289 part 524—ophthalmic and top- ical dosage form new ani

289

Food and Drug Administration, HHS Pt. 524

(2) Indications for use. To reverse theeffects of xylazine in dogs.

(3) Limitations. For intravenous use indogs only. Not for use in food-pro-ducing animals. Safety of use in preg-nant dogs or in dogs intended for breed-ing has not been established. Federallaw restricts this drug to use by or onthe order of a licensed veterinarian.

(c) Sponsor. See 053923 in § 510.600(c) ofthis chapter for use of 5 milligrams permilliliter solution in deer and elk.

(1) Amount. 0.2 to 0.3 milligram perkilogram of body weight.

(2) Indications for use. As an antago-nist to xylazine sedation in free rang-ing or confined members of the familyCervidae (deer and elk).

(3) Limitations. For intravenous useonly. Do not use in domestic food-pro-ducing animals. Do not use for 30 daysbefore or during hunting season. Fed-eral law restricts this drug to use by oron the order of a licensed veterinarian.

[58 FR 8543, Feb. 16, 1993, as amended at 60FR 57832, Nov. 22, 1995]

§ 522.2680 Zeranol.(a) Specifications. Each pellet con-

tains 12 milligrams of zeranol.(b) Sponsor. See 000061 in § 510.600(c) of

this chapter.(c) Related tolerances. See § 556.760 of

this chapter.(d) Conditions of use. For use as a sub-

cutaneous ear implant as follows:(1) Beef cattle—(i) Amount. 36 milli-

grams (three 12-milligram pellets) peranimal.

(ii) Indications for use—(A) For in-creased rate of weight gain and im-proved feed conversion in weaned beefcalves, growing beef cattle, feedlotsteers, and feedlot heifers.

(B) For increased rate of weight gainin suckling calves.

(iii) Limitations. Implantsubcutaneously in ear only. Do not usein bulls intended for reproduction or indairy animals. Do not use before 1month of age or after weaning in heif-ers intended for reproduction.

(2) Feedlot lambs—(i) Amount. 12 milli-grams (1 pellet) per animal.

(ii) Indications for use. For increasedrate of weight gain and improved feedconversion.

(iii) Limitations. Implantsubcutaneously in ear only. Do not use

in breeding animals. Do not implantanimals within 40 days of slaughter.

(3) Steers—(i) Amount. 72 milligrams(six 12-milligram pellets) per animal.

(ii) Indications for use. For increasedrate of weight gain and improved feedefficiency in steers fed in confinementfor slaughter.

(iii) Limitations. Implantsubcutaneously in ear only.

[59 FR 19639, Apr. 25, 1994; 60 FR 26360, May17, 1995, as amended at 62 FR 61625, Nov. 19,1997; 64 FR 46840, Aug. 27, 1999]

PART 524—OPHTHALMIC AND TOP-ICAL DOSAGE FORM NEW ANI-MAL DRUGS

Sec.524.86 Amitraz liquid.524.154 Bacitracin or bacitracin zinc-neomy-

cin sulfate-polymyxin B sulfate oph-thalmic ointment.

524.155 Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hy-drocortisone acetate ophthalmic oint-ment.

524.321 Cephalonium, polymyxin B sulfate,flumethasone, iodochlorhydroxyquin,piperocaine hydrochloride topical-oticointment.

524.390 Chloramphenicol ophthalmic andtopical dosage forms.

524.390a Chloramphenicol ophthalmic oint-ment.

524.390b Chloramphenicol ophthalmic solu-tion.

524.390c Chloramphenicol-prednisolone-tet-racaine-squalane topical suspension.

524.390d Chloramphenicol-prednisolone oph-thalmic ointment.

524.402 Chlorhexidine diacetate ointment.524.450 Clotrimazole cream.524.463 Copper naphthenate solution.524.520 Cuprimyxin cream.524.575 Cyclosporine ophthalmic ointment.524.660 Dimethyl sulfoxide ophthalmic and

topical dosage forms.524.660a Dimethyl sulfoxide solution.524.660b Dimethyl sulfoxide gel.524.770 Doramectin.524.814 Eprinomectin.524.900 Famphur.524.920 Fenthion.524.960 Flumethasone, neomycin sulfate,

and polymyxin B sulfate ophthalmic so-lutions.

524.981 Fluocinolone acetonide ophthalmicand topical dosage forms.

524.981a Fluocinolone acetonide cream.524.981b Fluocinolone acetonide solution.524.981c Fluocinolone acetonide, neomycin

sulfate cream.

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21 CFR Ch. I (4–1–00 Edition)§ 524.86

524.981d Fluocinolone acetonide, dimethylsulfoxide solution.

524.981e Fluocinolone acetonide, dimethylsulfoxide otic solution.

524.1005 Furazolidone aerosol powder.524.1044 Gentamicin sulfate ophthalmic and

topical dosage forms.524.1044a Gentamicin ophthalmic solution.524.1044b Gentamicin sulfate,

betamethasone valerate otic solution.524.1044c Gentamicin ophthalmic ointment.524.1044d Gentamicin sulfate,

betamethasone valerate ointment.524.1044e Gentamicin sulfate spray.524.1044f Gentamicin sulfate,

betamethasone valerate topical spray.524.1044g Gentamicin sulfate,

betamethasone valerate, clotrimazoleointment.

524.1193 Ivermectin pour-on.524.1200 Kanamycin ophthalmic and topical

dosage forms.524.1200a Kanamycin ophthalmic ointment.524.1200b Kanamycin ophthalmic aqueous

solution.524.1204 Kanamycin sulfate, calcium

amphomycin, and hydrocortisone ace-tate.

524.1240 Levamisole.524.1376 2-Mercaptobenzothiazole solution.524.1443 Miconazole nitrate cream;

miconazole nitrate lotion; miconazole ni-trate spray.

524.1446 Milbemycin oxime solution.524.1451 Moxidectin.524.1465 Mupirocin ointment.524.1484 Neomycin sulfate ophthalmic and

topical dosage forms.524.1484a Neomycin sulfate ophthalmic oint-

ment.524.1484b Neomycin sulfate, isoflupredone

acetate, tetracaine hydrochloride, andmyristyl-gamma-picolinium chloride,topical powder.

524.1484c Neomycin sulfate, isoflupredoneacetate, tetracaine hydrochloride oint-ment.

524.1484d Neomycin sulfate, hydrocortisoneacetate, tetracaine hydrochloride earointment.

524.1484e Neomycin sulfate and polymyxin Bsulfate ophthalmic solution.

524.1484f Neomycin sulfate, prednisolone ac-etate, tetracaine hydrochloride eardrops.

524.1484g Neomycin sulfate-thiabendazole-dexamethasone solution.

524.1484h Neomycin, penicillin, polymyxin,hydrocortisone suspension.

524.1484i Neomycin sulfate, hydrocortisoneacetate, sterile ointment.

524.1484j [Reserved]524.1484k Neomycin sulfate, prednisolone,

tetracaine, and squalane topical-otic sus-pension.

524.1580 Nitrofurazone ophthalmic and top-ical dosage forms.

524.1580a [Reserved]

524.1580b Nitrofurazone ointment.524.1580c Nitrofurazone soluble powder.524.1580d [Reserved]524.1580e Nitrofurazone ointment with buta-

caine sulfate.524.1600 Nystatin ophthalmic and topical

dosage forms.524.1600a Nystatin, neomycin, thiostrepton,

and triamcinolone acetonide ointment.524.1600b Nystatin, neomycin, thiostrepton,

and triamcinolone acetonide ophthalmicointment.

524.1662 Oxytetracycline hydrochloride oph-thalmic and topical dosage forms.

524.1662a Oxytetracycline hydrochloride andhydrocortisone spray.

524.1662b Oxytetracycline hydrochloride,polymyxin B sulfate ophthalmic oint-ment.

524.1742 N-(Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate) emul-sifiable liquid.

524.1880 Prednisolone-neomycin sulfate oph-thalmic ointment.

524.1881 Prednisolone acetate ophthalmicand topical dosage forms.

524.1881a [Reserved]524.1881b Prednisolone acetate-neomycin

sulfate sterile suspension.524.1883 Prednisolone sodium phosphate-ne-

omycin sulfate ophthalmic ointment.524.1982 Proparacaine hydrochloride oph-

thalmic solution.524.2098 Selamectin.524.2101 Selenium disulfide suspension.524.2140 Squalane, pyrethrins and piperonyl

butoxide.524.2350 Tolnaftate cream.524.2481 Triamcinolone acetonide cream.524.2620 Liquid crystalline trypsin, Peru

balsam, castor oil.524.2640 Tylosin, neomycin eye powder.

AUTHORITY: 21 U.S.C. 360b.

SOURCE: 40 FR 13873, Mar. 27, 1975, unlessotherwise noted.

§ 524.86 Amitraz liquid.(a) Specifications. Amitraz liquid con-

tains 19.9 percent amitraz in an organicsolvent.

(b) Sponsor. See No. 000009 in§ 510.600(c) of this chapter.

(c) Conditions of use—(1) Indicationsfor use. For dogs for the treatment ofgeneralized demodicosis (Demodexcanis).

(2) Amount. One 10.6 milliliter bottleper 2 gallons of warm water (250 partsper million) for each treatment, for atotal of 3 to 6 treatments, 14 daysapart.

(3) Limitations. Continue treatmentuntil no viable mites are found in skin


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Food and Drug Administration, HHS § 524.321

scrapings at 2 successive treatments,or until 6 treatments have been ap-plied. Do not use for treatment of lo-calized demodicosis or scabies. Federallaw restricts this drug to use by or onthe order of a licensed veterinarian.

[47 FR 18589, Apr. 30, 1982]

§ 524.154 Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sul-fate ophthalmic ointment.

(a) Sponsor. To firms identified in§ 510.600(c) of this chapter as follows:

(1) To 000009; each gram contains 500units of bacitracin, 3.5 milligrams ofneomycin, and 10,000 units of poly-myxin B.

(2) To 000061 and 025463; each gramcontains 400 units of bacitracin zinc, 3.5milligrams of neomycin, and 10,000units of polymyxin B sulfate.

(b) Conditions of use. Dogs and Cats.(1) Amount. Apply a thin film over thecornea 3 or 4 times daily.

(2) Indications for use. Treatment ofsuperficial bacterial infections of theeyelid and conjunctiva of dogs and catswhen due to susceptible organisms.

(3) Limitations. Laboratory testsshould be conducted including in vitroculturing and susceptibility tests onsamples collected prior to treatment.Federal law restricts this drug to useby or on the order of a licensed veteri-narian.

[57 FR 37333, Aug. 18, 1992, as amended at 61FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19,1997]

§ 524.155 Bacitracin zinc-polymyxin Bsulfate-neomycin sulfate-hydro-cortisone or hydrocortisone acetateophthalmic ointment.

(a) Sponsor. To firms identified in§ 510.600(c) of this chapter as follows:

(1) To 000061; each gram of ointmentcontains 400 units of bacitracin zinc,10,000 units of polymyxin B sulfate, 5milligrams of neomycin sulfate (equiv-alent to 3.5 milligrams of neomycinbase), and 10 milligrams of hydro-cortisone.

(2) To 025463; each gram of ointmentcontains 400 units of bacitracin zinc,10,000 units of polymyxin B sulfate, 5milligrams of neomycin sulfate (equiv-alent to 3.5 milligrams of neomycin

base), and 10 milligrams of hydro-cortisone acetate.

(b) Conditions of use. Dogs and cats. (1)Amount. Apply a thin film over the cor-nea three or four times daily.

(2) Indications for use. For treatingacute or chronic conjunctivitis causedby susceptible organisms.

(3) Limitations. All topical ophthalmicpreparations containing corticosteroidswith or without an antimicrobial agentare contraindicated in the initial treat-ment of corneal ulcers. They shouldnot be used until the infection is undercontrol and corneal regeneration iswell underway. Federal law restrictsthis drug to use by or on the order of alicensed veterinarian.

[57 FR 37333, Aug. 18, 1992, as amended at 61FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19,1997]

§ 524.321 Cephalonium, polymyxin Bsulfate, flumethasone, iodochlorhy-droxyquin, piperocaine hydro-chloride topical-otic ointment.

(a) Specifications. Each gram of thedrug contains 10 milligramscephalonium, 5,000 units polymyxin Bsulfate, 0.25 milligram flumethasone, 30milligrams iodochlorhydroxyquin, and40 milligrams piperocaine hydro-chloride in a suitable and harmlessointment base.


(c) Conditions of use. The drug is rec-ommended for dermal and otic use ondogs and cats for the treatment of thefollowing conditions when complicatedby bacteria, yeast, or fungus:Pyodermatitis, allergic dermatitis,dermatophytosis, nonspecific pruritus,and external otitis. For mild inflam-mations a periodic treatment of apply-ing from once daily to twice weeklymay be indicated. In severe conditionsapply once or twice daily when contin-uous treatment may be indicated. Dos-age per treatment should not exceed300 milligrams of the ointment. Forotic use treatment should not exceed atotal of 12 days. For use only by or onthe order of a licensed veterinarian.


292

21 CFR Ch. I (4–1–00 Edition)§ 524.390

§ 524.390 Chloramphenicol ophthalmicand topical dosage forms.

§ 524.390a Chloramphenicol oph-thalmic ointment.

(a) Specifications. Each gram contains10 milligrams chloramphenicol in apetrolatum base.

(b) Sponsor. See Nos. 000856 and 025463in § 510.600(c) of this chapter for use asin paragraph (c)(1)(i) of this section.See No. 017030 for use as in paragraph(c)(1)(ii) of this section.

(c) Conditions of use. Dogs and cats. (1)Amount. Apply as follows:

(i) Every 3 hours around the clock for48 hours after which night instillationsmay be omitted.

(ii) Four to six times daily to af-fected eye for the first 72 hours depend-ing upon the severity of the condition.A small amount of ointment should beplaced in the lower conjunctival sac.

(2) Indications for use. Treatment ofbacterial conjunctivitis caused bypathogens susceptible to chloramphen-icol.

(3) Limitations. Continue treatmentfor 48 hours (2 days) after eye appearsnormal. Therapy for cats should notexceed 7 days. Prolonged use in catsmay produce blood dyscrasias. If im-provement is not noted in a few days achange of therapy should be consid-ered. When infection may be cause ofdisease, especially in purulent or ca-tarrhal conjunctivitis, attempts shouldbe made to determine through suscep-tibility testing, which antibiotics willbe effective prior to applying oph-thalmic preparations. This chlor-amphenicol product must not be usedin animals producing meat, eggs, ormilk. The length of time that residuespersist in milk or tissues has not beendetermined. Federal law restricts thisdrug to use by or on the order of a li-censed veterinarian.

[57 FR 37333, Aug. 18, 1992]

§ 524.390b Chloramphenicol oph-thalmic solution.

(a) Specifications. Each milliliter con-tains 5 milligrams of chloramphenicol.


(c) Conditions of use. Dogs and Cats. (1)Amount. Apply one or two drops, 4 to 6times a day for the first 72 hours, de-

pending upon the severity of the condi-tion. Intervals between applicationsmay be increased after the first 2 days.

(2) Indications for use. Treatment ofbacterial conjunctivitis caused by or-ganisms susceptible to chloramphen-icol. Therapy should be continued for48 hours after the eye appears normal.

(3) Limitations. Therapy for catsshould not exceed 7 days. As with otherantibiotics, prolonged use may resultin overgrowth of nonsusceptible orga-nisms. If superinfection occurs, or ifclinical improvement is not notedwithin a reasonable period, discontinueuse, and institute appropriate therapy.Prolonged use in cats may produceblood dyscrasias. Chloramphenicolproducts must not be used in meat-,egg-, or milk-producing animals. Thelength of time that residues persist inmilk or tissues has not been deter-mined. Federal law restricts this drugto use by or on the order of a licensedveterinarian.

[57 FR 37333, Aug. 18, 1992]

§ 524.390c Chloramphenicol-prednis-olone-tetracaine-squalane topicalsuspension.

(a) Specification. Each milliliter con-tains 4.2 milligrams of chloramphen-icol, 1.7 milligrams of prednisolone, 4.2milligrams of tetracaine, and 0.21 mil-liliter of squalane.


(c) Conditions of use. Dogs and cats. (1)Amount. Apply two or three times dailyor as needed for not more than 7 days.Severe infections should be supple-mented by systemic therapy.

(2) Indications for use. Treatment ofacute otitis externa and pyodermas(acute moist dermatitis, vulvar folddermatitis, lip fold dermatitis, inter-digital dermatitis, and juvenile derma-titis) in dogs and cats.

(3) Limitations. The drug must not beused in the eyes. Prolonged use in catsmay produce blood dyscrasias. Labora-tory tests should be conducted, includ-ing in vitro culturing and suscepti-bility tests on samples collected priorto treatment. Chloramphenicol prod-ucts must not be used in meat-, egg-, ormilk-producing animals. The length oftime that residues persist in milk or


293


1 These conditions are NAS/NRC reviewedand found effective. Applications for theseuses need not include effectiveness data asspecified by § 514.111 of this chapter, but mayrequire bioequivalency and safety informa-tion.

tissues has not been determined. Fed-eral law restricts this drug to use by oron the order of a licensed veterinarian.

[57 FR 37334, Aug. 18, 1992]

§ 524.390d Chloramphenicol-prednis-olone ophthalmic ointment.

(a) Specifications. Each gram contains10 milligrams of chloramphenicol and2.5 milligrams of prednisolone acetate.


(c) Conditions of use. Dogs and cats. (1)Amount. Apply 4 to 6 times daily to theaffected eye for the first 72 hours de-pending upon the severity of the condi-tion. Continue treatment for 48 hoursafter the eye appears normal.

(2) Indications for use. Treatment ofbacterial conjunctivitis and ocular in-flammation caused by organisms sus-ceptible to chloramphenicol.

(3) Limitations. Therapy for catsshould not exceed 7 days, prolonged usein cats may produce blood dyscrasia.As with other antibiotics, prolongeduse may result in overgrowth of non-susceptible organisms. If superinfec-tion occurs or if clinical improvementis not noted within a reasonable period,discontinue use and institute appro-priate therapy. All topical ophthalmicpreparations containingcorticosteroids, with or without anantimicrobial agent, are contra-indicated in the initial treatment ofcorneal ulcers. They should not be useduntil the infection is under control andcorneal regeneration is well underway.Chloramphenicol products must not beused in meat-, egg-, or milk-producinganimals. The length of time that resi-dues persist in milk or tissues has notbeen determined. Federal law restrictsthis drug to use by or on the order of alicensed veterinarian.

[57 FR 37334, Aug. 18, 1992]

§ 524.402 Chlorhexidine diacetate oint-ment.

(a) Specifications. The product con-tains 1 percent of chlorhexidine diace-tate in an ointment base.


(c) Conditions of use. (1) The drug isused as a topical antiseptic ointment

for surface wounds on dogs, cats, andhorses.1

(2) The wound area is carefullycleansed and the drug is applied daily.1

(3) The drug is not to be used inhorses intended for use as food.1

§ 524.450 Clotrimazole cream.

(a) Specifications. Each gram of creamcontains 10 milligrams of clotrimazole.

(b) Sponsor. See 000859 in § 510.600(c).(c) Conditions of use—(1) Amount.

Apply 1⁄4-inch ribbon of cream persquare inch of lesion once daily for 2 to4 weeks.

(2) Indications of use. For the treat-ment of fungal infections of dogs andcats caused by Microsporum canis andTrichophyton mentagrophytes.

(3) Limitations. Wash hands thor-oughly after use to avoid spread of in-fection. Federal law restricts this drugto use by or on the order of a licensedveterinarian.

[40 FR 48128, July 18, 1980]

§ 524.463 Copper naphthenate solu-tion.

(a) Specifications. The drug contains37.5 percent copper naphthenate in asuitable solvent.

(b) Sponsor. See Nos. 000856 and 017135in § 510.600(c) of this chapter.

(c) Conditions of use—Horses andponies—(1) Amount. Apply daily to af-fected hooves until fully healed.

(2) Indications for use. As an aid intreating horses and ponies for thrushcaused by organisms susceptible tocopper naphthenate.

(3) Limitations. Use on horses andponies only. Remove debris and necrot-ic material before applying. Avoid con-tact around eyes. Do not use on ani-mals that are raised for food produc-tion. Do not contaminate feed. Do notallow runoff of excess drug into hairbecause contact with the drug maycause some hair loss.

[47 FR 4250, Jan. 29, 1982]


294

21 CFR Ch. I (4–1–00 Edition)§ 524.520

§ 524.520 Cuprimyxin cream.

(a) Specifications. The drug contains0.5 percent cuprimyxin (6-methoxy-1-phenazinol 5, 10-dioxide, cupric com-plex) in an aqueous cream base.


(c) Conditions of use. (1) Cuprimyxin isa broad spectrum antibacterial andantifungal cream for the topical treat-ment of superficial infections inhorses, dogs, and cats caused by bac-teria, dermatophytes (Trichophytonspp., Microsporum spp.) and yeast(Candida albicans) affecting skin, hair,and external mucosae.

(2) The cream is applied twice dailyto affected areas by rubbing into le-sions. Treatment should be continuedfor a few days after clinical recovery toavoid possible relapses.

(3) After application to cutaneousareas, a change in color from darkgreen to pink is due to the liberation offree myxin from its copper complex.

(4) If no response is seen within sevendays, diagnosis and therapy should bereevaluated. If any adverse local reac-tion is observed after topical applica-tion, discontinue treatment.

(5) Federal law restricts this drug touse by or on the order of a licensed vet-erinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 45FR 56799, Aug. 26, 1980]

§ 524.575 Cyclosporine ophthalmicointment.

(a) Specifications. Each gram of oint-ment contains 2 milligrams ofcyclosporine.


(c) Conditions of use—(1) Amount.Apply a 1/4-inch strip of ointment tothe affected eye(s) every 12 hours.

(2) Indications for use. For manage-ment of chronic keratoconjunctivitissicca (KCS) and chronic superficialkeratitis (CSK) in dogs.

(3) Limitations. Place ointment di-rectly on cornea or into the conjunc-tival sac. Safety of use in puppies,pregnant or breeding animals has notbeen determined. Federal law restricts

this drug to use by or on the order of alicensed veterinarian.

[60 FR 48651, Sept. 20, 1995, as amended at 62FR 48940, Sept. 18, 1997]

§ 524.660 Dimethyl sulfoxide oph-thalmic and topical dosage forms.

§ 524.660a Dimethyl sulfoxide solution.

(a) Specifications. Dimethyl sulfoxidecontains 90 percent of dimethyl sulf-oxide and 10 percent of water.


(c) Conditions of use. (1) It is used orintended for use as a topical applica-tion to reduce acute swelling due totrauma:

(i) In horses administered 2 or 3 timesdaily in an amount not to exceed 100milliliters per day. Total duration oftherapy should not exceed 30 days.

(ii) In dogs administered 3 or 4 timesdaily in an amount not to exceed 20milliliters per day. Total duration oftherapy should not exceed 14 days.

(2) Not for use in horses and dogs in-tended for breeding purposes nor inhorses slaughtered for food. Other top-ical medications should only be usedwhen the dimethyl sulfoxide treatedarea is thoroughly dry. Do not admin-ister by any other route.

(3) For use by or on the order of a li-censed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61FR 5507, Feb. 13, 1996]

§ 524.660b Dimethyl sulfoxide gel.

(a) Specifications. Dimethyl sulfoxidegel, veterinary contains 90 percent di-methyl sulfoxide in an aqueous gel.


(c) Conditions of use—(1) Indicationsfor use. For use on horses and dogs as atopical application to reduce acuteswelling due to trauma.

(2) Amount—(i) Horses. Administer 2or 3 times daily in an amount not toexceed 100 grams per day. Total dura-tion of therapy should not exceed 30days.

(ii) Dogs. Administer 3 or 4 timesdaily in an amount not to exceed 20grams per day. Total duration of ther-apy should not exceed 14 days.


295


(3) Limitations. Do not use in horsesand dogs intended for breeding pur-poses or in horses slaughtered for food.Restricted to topical use on horses anddogs only. Due to rapid penetratingability of dimethyl sulfoxide, rubbergloves should be worn when applyingthe drug. No other medications shouldbe present on the skin prior to applica-tion of the drug. Federal law restrictsthis drug to use by or on the order of alicensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 48FR 56205, Dec. 20, 1983; 61 FR 5507, Feb. 13,1996]

§ 524.770 Doramectin.(a) Specifications. Each milliliter of

solution contains 5 milligrams ofdoramectin.

(b) Sponsor. See 000069 in § 510.600(c) ofthis chapter.

(c) Related tolerances. See § 556.225 ofthis chapter.

(d) Conditions of use—Cattle—(1)Amount. 5 milligrams per 10 kilograms(5 milligrams per 22 pounds).

(2) Indications for use. For treatmentand control of gastrointestinalroundworms, lungworms, eyeworms,grubs, biting and sucking lice, hornflies, and mange mites. To control in-fections and to protect from reinfec-tion with Cooperia oncophora andDictyocaulus viviparus for 21 days,Ostertagia ostertagi, C. punctata, andOesophagostomum radiatum for 28 days,and Haemonchus placei for 35 days aftertreatment.

(3) Limitations. Administer as a singledose. Do not slaughter cattle within 45days of latest treatment. Not for use infemale dairy cattle 20 months of age orolder. Do not use in calves to be proc-essed for veal. Consult your veteri-narian for assistance in the diagnosis,treatment, and control of parasitism.

[62 FR 65753, Dec. 16, 1997, as amended at 63FR 68183, Dec. 10, 1998; 64 FR 49082, Sept. 10,1999]

§ 524.814 Eprinomectin.(a) Specifications. Each milliliter con-

tains 5 milligrams of eprinomectin.(b) Sponsor. See No. 000006 in

§ 510.600(c) of this chapter.(c) Related tolerances. See § 556.227 of

this chapter.

(d) Conditions of use—(1) Amount. Onemilliliter (5 milligrams) per 10 kilo-grams of body weight (500 microgramsper kilogram).

(2) Indications for use. The drug isused in beef and dairy cattle for treat-ment and control of gastrointestinalroundworms (Haemonchus placei (adultand L4), Ostertagia ostertagi (adult andL4, including inhibited L4),Trichostrongylus axei (adult and L4), T.colubriformis (adult and L4), T.longispicularis (adult), Cooperiaoncophora (adult and L4), C. punctata(adult and L4), C. surnabada (adult andL4), Nematodirus helvetianus (adult andL4), Bunostomum phlebotomum (adultand L4), Oesophagostomum radiatum(adult and L4), Strongyloides papillosus(adults), Trichuris spp. (adults));lungworms (Dictyocaulus viviparus,adult and L4); cattle grubs (all para-sitic stages Hypoderma lineatum, H.bovis); lice (Damalinia bovis,Linognathus vituli, Haematopinuseurysternus, Solenopotes capillatus);mange mites (Chorioptes bovis, Sarcoptesscabiei); and horn flies (Haematobiairritans). Controls and protects from re-infection of D. vivaparus for 21 daysafter treatment and H. irritans for 7days after treatment.

(3) Limitations. Apply topically alongbackbone from withers to tailhead.Consult your veterinarian for assist-ance in the diagnosis, treatment, andcontrol of parasitism.

[62 FR 33997, June 24, 1997, as amended at 63FR 59715, Nov. 5, 1998]

§ 524.900 Famphur.(a) Chemical name. O,O- Dimethyl O-

[p-(dimethylsulfamoyl)phenyl]phosphorothioate.

(b) Specifications. The drug is in liquidform containing 13.2 percent famphur.

(c) Sponsor. See Nos. 000061 and 060594in § 510.600(c) of this chapter.

(d) Special considerations. Do not useon animals simultaneously or within afew days before or after treatment withor exposure to cholinesterase-inhib-iting drugs, pesticides, or chemicals.

(e) Related tolerances. See § 556.273 ofthis chapter.

(f) Conditions of use. (1) The drug isused as a pour-on formulation for thecontrol of cattle grubs and to reducecattle lice infestations.


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21 CFR Ch. I (4–1–00 Edition)§ 524.920

(2) It is used at the rate of 1 ounceper 200 pounds body weight, not to ex-ceed a total dosage of 4 ounces, appliedfrom the shoulder to the tail head as asingle treatment. It is applied as soonas possible after heel fly activityceases. Do not use on lactating dairycows or dry dairy cows within 21 daysof freshening, calves less than 3 monthsold, animals stressed from castration,over-excitement or dehorning, sick orconvalescent animals. Animals may be-come dehydrated and under stress fol-lowing shipment. Do not treat untilthey are in good condition. Brahmanand Brahman crossbreeds are less tol-erant of cholinesterase-inhibiting in-secticides than other breeds. Do nottreat Brahman bulls.

(3) Do not slaughter within 35 daysafter treatment. Swine should be elimi-nated from area where run-off occurs.

[40 FR 13873, Mar. 27, 1975, as amended at 49FR 34352, Aug. 30, 1984; 57 FR 7652, Mar. 4,1992; 59 FR 28769, June 3, 1994; 62 FR 55161,Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997]

§ 524.920 Fenthion.(a) Chemical name. O,O-Dimethyl O-[4-

(methylthio)-m- tolyl]phosphorothioate.

(b) Specifications. (1) The drug is in aliquid form containing 3 percent offenthion.

(2) Sponsor. See No. 000859 in§ 510.600(c) of this chapter.

(3) Special considerations. Do not useon animals simultaneously or within afew days before or after treatment withor exposure to cholinesterase-inhib-iting drugs, pesticides, or chemicals.

(4) Related tolerances. See 40 CFR180.214.

(5) Conditions of use. (i) The drug isused as a pour-on formulation for thecontrol of grubs and lice in beef andnonlactating cattle.

(ii) It is used at the rate of one-halffluid ounce per 100 pounds of bodyweight placed on the backline of theanimal. Only one application per sea-son should be made for grub controland this will also provide initial con-trol of lice. A second application forlice control may be made if animals be-come reinfested, but no sooner than 35days after the first treatment. Propertiming of treatment is important forgrub control; cattle should be treated

as soon as possible after heel-fly activ-ity ceases. Cattle should not be slaugh-tered within 35 days following a singletreatment. If a second application ismade for lice control, cattle should notbe slaughtered within 45 days of thesecond treatment. The drug must notbe used within 28 days of freshening ofdairy cattle. If freshening should occurwithin 28 days after treatment, do notuse milk as human food for the balanceof the 28-day interval. Do not treat lac-tating dairy cattle; calves less than 3months old; or sick, convalescent, orstressed livestock. Do not treat cattlefor 10 days before or after shipping,weaning, or dehorning or after expo-sure to contagious infectious diseases.

(c) Specifications. (1) The drug is in aliquid form containing 20 percentfenthion.


(3) Special considerations. Do not useon animals simultaneously or within afew days before or after treatment withor exposure to cholinesterase-inhib-iting drugs, pesticides, or chemicals.

(4) Related tolerances. See 40 CFR180.214.

(5) Conditions of use. (i) The drug isused for control of cattle grubs and asan aid in controlling lice on beef cattleand on dairy cattle not of breeding age.

(ii) It is applied as a single applica-tion placed on the backline of animalsas follows:

Weight of animal Dosage(milliliters)

150 to 300 lb ....................................................... 4301 to 600 lb ....................................................... 8601 to 900 lb ....................................................... 12901 to 1,200 lb .................................................... 16Over 1,200 lb ....................................................... 20

For most effective results, cattleshould be treated as soon as possibleafter heel-fly activity ceases. Host-parasite reactions such as bloat, saliva-tion, staggering and paralysis maysometimes occur when cattle are treat-ed while the common cattle grub(Hypoderma lineatum) is in the gullet,or while the northern cattle grub (H.bovis) is in the area of the spinal cord.Cattle should be treated before thesestages of grub development. Consultyour veterinarian, extension livestockspecialist, or extension entomologist


297


regarding the timing of treatment. If itis impossible to determine the areafrom which the cattle came and/orexact stage of the grubs, it is rec-ommended that the cattle receive onlya maintenance ration of low-energyfeed during the treatment period. Thislessens the likelihood of severe bloatwhich may occur in cattle on full feedwhen the common grub is killed whilein the gullet. A second application isrequired for animals heavily infestedwith lice or for those which become re-infested. A second application shouldbe made no sooner than 35 days afterthe first treatment.

(iii) Do not treat dairy cattle ofbreeding age; calves less than 3 monthsold; sick, convalescent, or severelystressed livestock.

(iv) Do not treat cattle for 10 days be-fore or after shipping, weaning, dehorn-ing, or after exposure to contagious orinfectious diseases.

(v) Do not slaughter within 45 days oftreatment.

(d) Specifications. (1) The drug is a so-lution containing either 5.6 or 13.8 per-cent fenthion. Each concentration isavailable in 2 volumes which are con-tained in single-dose applicators.


(3) Special considerations. Fenthion isa cholinesterase inhibitor. Do not usethis product on dogs simultaneouslywith or within 14 days before or aftertreatment with or exposure to cholin-esterase-inhibiting drugs, pesticides, orchemicals. Do not use with flea or tickcollars.

(4) Conditions of use—(i) Amount. Fourto 8 milligrams per kilogram of bodyweight.

(ii) Indications for use. For flea con-trol on dogs only.

(iii) Limitations. Apply the contentsof the proper size, single-dose tube di-rectly to one spot on the dog’s skin.Frequency of repeat treatments de-pends upon rate of flea reinfestations.Do not use more often than once every2 weeks. Treatment at 2-week intervalsis not to exceed 6 months. Do not useon puppies under 10 weeks of age. Donot use on sick, stressed, or conva-lescing dogs. Safe use in breedingmales has not been established. Federal

law restricts this drug to use by or onthe order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 41FR 16656, Apr. 21, 1976; 42 FR 58741, Nov. 11,1977; 45 FR 62425, Sept. 19, 1980; 50 FR 19169,May 7, 1985]

§ 524.960 Flumethasone, neomycin sul-fate, and polymyxin B sulfate oph-thalmic solutions.

(a) Specifications. Each milliliter ofophthalmic preparation contains 0.10milligram flumethasone, 5.0 milligramsneomycin sulfate (3.5 milligrams neo-mycin base), and 10,000 units of poly-myxin B sulfate, with or withouthydroxypropyl methylcellulose.


(c) Conditions of use—(1) Amount—(i)Preparation containing hydroxypropylmethylcellulose. Dogs: 1 to 2 drops pereye, every 6 hours.

(ii) Preparation without hydroxyproplymethylcellulose. Dogs and cats: 2 to 3drops per eye, every 4 hours.

(2) Indications for use. Treatment ofthe inflammation, edema, and sec-ondary bacterial infections associatedwith topical ophthalmological condi-tions of the eye such as corneal inju-ries, incipient pannus, superficial kera-titis, conjunctivitis, acutenongranulomatous anterior uveitis,keratoconjunctivitis, and blepharitis.

(3) Limitations. (i) In treating oph-thalmological conditions associatedwith bacterial infections, the drug iscontraindicated in those cases in whichmicroorganisms are not susceptible tothe antibiotics incorporated in thedrug.

(ii) The drug is contraindicated in in-fectious tuberculous lesions of the eye,early acute stages of viral diseases ofthe cornea and conjunctiva, herpessimplex lesions of the eye, and fungalinfections of the conjunctiva and eye-lids.

(iii) The usual precautions and con-traindications for corticosteroids andadrenocorticoids are applicable withthis drug. Corticosteroids may inhibitessential inflammatory responses in-trinsic to the fundamental healingmechanism. Adrenocorticoid com-pounds have been reported to cause an


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21 CFR Ch. I (4–1–00 Edition)§ 524.981

increase in intraocular pressure. Intra-ocular pressure should be checked fre-quently. Ocular reexaminations shouldbe made at frequent intervals duringlong-term therapy.

(iv) Federal law restricts this drug touse by or on the order of a licensed vet-erinarian.


§ 524.981 Fluocinolone acetonide oph-thalmic and topical dosage forms.

§ 524.981a Fluocinolone acetonidecream.

(a) Specifications. The drug contains0.025 percent fluocinolone acetonide.

(b) Sponsor. See No. 099207 in§510.600(c) of this chapter.

(c) Conditions of use. (1) The drug isindicated for the relief of pruritus andinflammation associated with certainsuperficial acute and chronicdermatoses in dogs. It is used in thetreatment of allergic and acute moistdermatitis and for the relief of super-ficial inflammation caused by chemicaland physical abrasions and burns.

(2) A small amount is applied to theaffected area two or three times daily.


[40 FR 13873, Mar. 27, 1975, as amended at 62FR 40932, July 31, 1997]

§ 524.981b Fluocinolone acetonide so-lution.

(a) Specifications. The drug contains0.01 percent fluocinolone acetonide inpropylene glycol with citric acid.

(b) Sponsor. See No. 099207 in§510.600(c) of this chapter.

(c) Conditions of use. (1) The drug isindicated for the relief of pruritus andinflammation associated with otitisexterna and certain superficial acuteand chronic dermatoses in the dog. It isalso indicated for the relief of pruritusand inflammation associated withacute otitis externa and certain super-ficial acute and chronic dermatoses inthe cat.

(2) A small amount of solution is ap-plied to the affected area 2 or 3 timesdaily.



§ 524.981c Fluocinolone acetonide, neo-mycin sulfate cream.

(a) Specifications. The drug contains0.025 percent fluocinolone acetonideand 0.5 percent neomycin sulfate (0.35percent neomycin base).


(c) Conditions of use. (1) The drug isused in the relief of pruritus and in-flammation associated with superficialacute and chronic dermatoses in dogs.It is used in the treatment of such con-ditions as allergic and acute moistdermatoses and nonspecific dermatosesin dogs. It is used in the treatment ofwound infections in dogs and cats.

(2) A small amount is applied to theinfected area two or three times daily.



§ 524.981d Fluocinolone acetonide, di-methyl sulfoxide solution.

(a) Specifications. Each milliliter ofsolution contains 0.01 percentfluocinolone acetonide and 20 percentdimethyl sulfoxide with propylene gly-col and citric acid.


(c) Conditions of use. (1) The drug isused in dogs for the relief of impactioncommonly present in apparently nor-mal anal sacs, for the reversal of in-flammatory changes associated withabnormal anal sacs, and to counteractthe offensive odor of anal sac secre-tions.

(2) It is administered by instillationof 1 to 2 milliliters into each anal sacfollowing expression of anal sac con-tents. It may be necessary to repeattreatment at 60-day intervals to main-tain an odor-free state. The total dos-age used should not exceed 2 millilitersper anal sac per treatment.


299


(3) For use only by or on the order ofa licensed veterinarian.


§ 524.981e Fluocinolone acetonide, di-methyl sulfoxide otic solution.

(a) Specifications. Each milliliter ofsolution contains 0.01 percent offluocinolone acetonide in 60 percent di-methyl sulfoxide with propylene glycoland citric acid.


(c) Conditions of use. (1) The drug isused in dogs for the relief of pruritisand inflammation associated withacute and chronic otitis.

(2) It is administered at 4 to 6 drops(0.2 milliliter) twice daily into the earcanal for a maximum period of 14 days.The total dosage used should not ex-ceed 17 milliliters. The ear canalshould be cleansed by some appropriatemethod prior to instillation of the so-lution and the ear should be massagedgently following instillation.

(3) There should be careful initialevaluation and followup of infectedears. Incomplete response or exacer-bation of corticosteroid-responsive le-sions may be due to the presence of aninfection which requires identificationor antibiotic sensitivity testing, andthe use of the appropriate anti-microbial agent. As with anycorticosteroid, animals with a general-ized infection should not be treatedwith this product without proper sup-portive antimicrobial therapy. Prep-arations with dimethyl sulfoxideshould not be used in pregnant ani-mals. For use by or on the order of a li-censed veterinarian.

§ 524.1005 Furazolidone aerosol pow-der.

(a) Specifications. The product con-tains either 4 or 10 percent furazolidonein inert dispersing agent and propel-lant.

(b) Sponsors. (1) See No. 000069 in§ 510.600(c) of this chapter for use of the10 percent product as in paragraphs(c)(2) (i) through (iii) of this section.

(2) See No. 017135 for use of the 4 per-cent product as in paragraph (c)(2)(iv)of this section.

(c) Conditions of use—(1) Amount. Holdcontainer about 6 to 12 inches from theeye or affected area and apply onlyenough powder to impart a light yellowcolor.

(2) Indications of use—(i) Dogs. Fortreatment or prevention of bacterialinfection of superficial wounds, abra-sions, lacerations, and pyogenic derma-titis.

(ii) Horses. For treatment or preven-tion of bacterial infection of superficialwounds, abrasions, lacerations, and fol-lowing firing (heat or electrocautery).

(iii) Cattle. For treatment of bac-terial infections of the bovine eye andfor treatment and to reduce the inci-dence of additional cases of infectiousbovine keratoconjunctivitis (pink eye)caused by Moraxella bovis.

(iv) Horses and ponies. For treatmentor prevention of bacterial infection ofsuperficial wounds, abrasions, and lac-erations caused by Staphylococcusaureus, Streptococcus spp. and Proteusspp. sensitive to furazolidone.

(3) Limitations. For topical applica-tion in horses, ponies, and dogs: Cleanaffected area thoroughly, apply drugonce or twice daily, and repeat treat-ment as required. For treatment ofbacterial infections of the bovine eyeand infectious bovinekeratoconjunctivitis (pink eye) causedby Moraxella bovis: Treat affected eyesonce daily on each of 3 to 5 consecutivedays; to reduce incidence of additionalcases of infectious keratoconjunctivitisalso medicate unaffected eyes. Evi-dence of clinical improvement of bo-vine eye infections should be notice-able after 5 treatments; if not, recon-sult veterinarian. Use only as rec-ommended by a veterinarian in treat-ment of puncture wounds, wounds re-quiring surgical debridement or sutur-ing, those of a chronic nature involvingproud flesh, generalized and chronic in-fections of the skin, and those skinconditions associated with intenseitching. If redness, irritation, or swell-ing persists or increases, discontinueuse and reconsult veterinarian. Not foruse in horses intended for food.

[45 FR 49543, July 25, 1980, as amended at 50FR 30153, July 24, 1985; 56 FR 50653, Oct. 8,1991; 57 FR 31314, July 15, 1992; 60 FR 55659,Nov. 2, 1995]


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21 CFR Ch. I (4–1–00 Edition)§ 524.1044

§ 524.1044 Gentamicin sulfate oph-thalmic and topical dosage forms.

§ 524.1044a Gentamicin ophthalmic so-lution.

(a) Specifications. Each milliliter ofsterile aqueous solution containsgentamicin sulfate equivalent to 3 mil-ligrams of gentamicin.


(c) Conditions of use. (1) The drug isused in dogs and cats for the topicaltreatment of infections of the con-junctiva caused by susceptible bac-teria.

(2) Administer 1 or 2 drops into theconjunctival sac 2 to 4 times a day.


[41 FR 14189, Apr. 2, 1976, as amended at 52FR 7832, Mar. 13, 1987]

§ 524.1044b Gentamicin sulfate,betamethasone valerate otic solu-tion.

(a) Specifications. Each cubic centi-meter of solution contains gentamicinsulfate equivalent to 3 milligrams ofgentamicin base and betamethasonevalerate equivalent to 1 milligram ofbetamethasone alcohol.


(c) Conditions of use. (1) The drug isused or indicated for use in dogs in thetreatment of acute and chronic otitisexterna caused by bacteria sensitive togentamicin; the drug is also used or in-dicated for use in dogs and cats in thetreatment of superficial infected le-sions caused by bacteria sensitive togentamicin.

(2)(i) For the treatment of acute andchronic canine otitis externa caused bybacteria sensitive to gentamicin, thedrug is administered by instillation of3 to 8 drops of solution into the earcanal twice daily for 7 to 14 days. Dura-tion of treatment will depend upon theseverity of the condition and the re-sponse obtained. The duration of treat-ment and/or frequency of the dosagemay be reduced but care should betaken not to discontinue therapy pre-maturely. The external ear and earcanal should be properly cleaned anddried before treatment. Remove foreign

material, debris, crusted exudates, etc.,with suitable nonirritating solutions.Excessive hair should be clipped fromthe treatment area of the external ear.

(ii) For the treatment of canine andfeline superficial infected lesionscaused by bacteria sensitive togentamicin, the lesion and adjacentarea should be properly cleaned beforetreatment. Excessive hair should be re-moved. A sufficient amount of the drugshould be applied to cover the treat-ment area. The drug should be adminis-tered twice daily for 7 to 14 days.

(3) If hypersensitivity to any of thecomponents occurs treatment with thisproduct should be discontinued and ap-propriate therapy instituted. Concomi-tant use with other drugs known to in-duce ototoxicity is not recommended.This preparation should not be used inconditions where corticosteroids arecontraindicated. Do not administerparenteral corticosteroids during treat-ment with this drug. The antibioticsensitivity of the pathogenic organismshould be determined prior to use ofthis preparation.


[40 FR 13873, Mar. 27, 1975. Redesignated at 41FR 14189, Apr. 2, 1976, and amended at 52 FR7832, Mar. 13, 1987; 61 FR 48624, Sept. 16, 1996]

§ 524.1044c Gentamicin ophthalmicointment.

(a) Specifications. Each gram of sterileointment contains gentamicin sulfateequivalent to 3 milligrams ofgentamicin.


(c) Conditions of use. (1) The drug isused on dogs and cats for topical treat-ment of conjunctivitis caused by sus-ceptible bacteria.

(2) Apply approximately a 1⁄2-inchstrip to the affected eye 2 to 4 times aday.


[41 FR 14188, Apr. 2, 1976, as amended at 52FR 7832, Mar. 13, 1987]

§ 524.1044d Gentamicin sulfate,betamethasone valerate ointment.

(a) Specifications. Each gram of oint-ment contains gentamicin sulfate


301

Food and Drug Administration, HHS § 524.1044f

equivalent to 3 milligrams ofgentamicin base and betamethasonevalerate equivalent to 1 milligram ofbetamethasone.


(c) Conditions of use. (1) The drug isused or indicated for use in dogs in thetreatment of acute and chronic canineotitis externa and canine infected su-perficial lesions caused by bacteriasensitive to gentamicin.

(2)(i) For the treatment of acute andchronic canine otitis externa the drugis administered by instillation of 3 to 8drops into the ear canal twice daily for7 days. The external ear and ear canalshould be properly cleaned and driedbefore treatment. Remove foreign ma-terial, debris, crusted exudates, etc.,with suitable nonirritating solutions.Excessive hair should be clipped fromthe treatment area of the external ear.

(ii) For the treatment of canine in-fected superficial lesions, the lesionand adjacent area should be properlycleaned before treatment. Excessivehair should be removed. A sufficientamount of the drug should be appliedto cover the treatment area. The drugshould be administered twice daily for7 to 14 days.

(3) If hypersensitivity to any of thecomponents occurs, treatment shouldbe discontinued and appropriate ther-apy instituted. Concomitant use ofdrugs known to induce ototoxicityshould be avoided. Observe patients forsigns of adrenocorticoid overdosage.The antibiotic susceptibility of thepathogenic organism should be deter-mined prior to use of this preparation.Administration of recommended dosesbeyond 7 days may result in delayedwound healing. Animals treated longerthan 7 days should be monitored close-ly.


[47 FR 26378, June 18, 1982, as amended at 52FR 7832, Mar. 13, 1987]

§ 524.1044e Gentamicin sulfate spray.(a) Specification. Each milliliter of

sterile aqueous solution containsgentamicin sulfate equivalent to 1.07milligrams of gentamicin.


(c) Conditions of use. (1) The drug isindicated for the treatment of pink eyein cattle (infectious bovinekeratoconjunctivitis) caused byMoraxella bovis.

(2) One actuation of the sprayer de-livers 0.7 milliliter containing 0.75 mil-ligram gentamicin. The sprayer shouldbe held upright 3 to 6 inches from theaffected eye, with the opening directedtowards the eye, and pumped once. It isadvisable to treat once a day for up to3 days.

(3) Conditions other than bacterialinfections of the bovine eye and infec-tious keratoconjunctivitis caused byMoraxella bovis may produce similarsigns. If conditions persists or in-creases, discontinue use and consultveterinarian.

[48 FR 41157, Sept. 14, 1983, as amended 52 FR7833, Mar. 13, 1987]

§ 524.1044f Gentamicin sulfate,betamethasone valerate topicalspray.

(a) Specifications. Each milliliter ofspray contains gentamicin sulfateequivalent to 0.57 milligram ofgentamicin base and betamethasonevalerate equivalent to 0.284 milligramof betamethasone.


(c) Conditions of use. (1) The drug isused in dogs in the treatment of in-fected superficial lesions caused bybacteria sensitive to gentamicin.

(2) For the treatment of infected su-perficial lesions, the lesion and adja-cent area should be properly cleanedbefore treatment. Excessive hairshould be removed. Hold bottle upright3 to 6 inches from the lesion and de-press the sprayer head twice. One actu-ation of the sprayer delivers 0.7 milli-liter of the spray. The drug should beadministered with two spray actu-ations 2 to 4 times daily for 7 days.

(3) If hypersensitivity to any of thecomponents occurs, treatment shouldbe discontinued and appropriate ther-apy instituted. The antibiotic suscepti-bility of the pathogenic organismshould be determined prior to use ofthis preparation. Administration ofrecommended doses beyond 7 days may


302

21 CFR Ch. I (4–1–00 Edition)§ 524.1044g

result in delayed wound healing. Ani-mals treated longer than 7 days shouldbe monitored closely.


[50 FR 740, Jan. 7, 1985, as amended at 52 FR7833, Mar. 13, 1987; 62 FR 10220, Mar. 6, 1997]

§ 524.1044g Gentamicin sulfate,betamethasone valerate,clotrimazole ointment.

(a) Specifications. Each gram (g) ofointment contains gentamicin sulfateequivalent to 3 milligrams (mg)gentamicin base, betamethasone val-erate equivalent to 1 mgbetamethasone, and 10 mgclotrimazole.

(b) Sponsor. See 000061 and 051259 in§ 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug isused for the treatment of canine otitisexterna associated with yeast(Malassezia pachydermatis, formerlyPityrosporum canis) and/or bacteria sus-ceptible to gentamicin.

(2) For 7.5 or 15 g tube, instill 4 dropsof ointment twice daily into the earcanal of dogs weighing less than 30pounds, instill 8 drops twice daily fordogs weighing 30 pounds or more. For215 g bottle, instill 2 drops of ointmenttwice daily into the ear canal of dogsweighing less than 30 pounds, instill 4drops twice daily for dogs weighing 30pounds or more. Therapy should con-tinue for 7 consecutive days.

(3) The external ear should be cleanedand dried before treatment. Removeforeign material, debris, crustedexudates, etc., with suitable solutions.Excessive hair should be clipped fromthe treatment area. If hypersensitivityoccurs, treatment should be discon-tinued and alternate therapy insti-tuted.

(4) Corticosteroids administered todogs, rabbits, and rodents during preg-nancy have resulted in cleft palate inoffspring. Other congenital anomaliesincluding deformed forelegs,phocomelia, and anasarca have been re-ported in offspring of dogs which re-ceived corticosteroids during preg-nancy. Clinical and experimental datahave demonstrated that corticosteroidsadministered orally or parenterally toanimals may induce the first stage of

parturition if used during the last tri-mester of pregnancy and may precipi-tate premature parturition followed bydystocia, fetal death, retained pla-centa, and metritis.


[58 FR 38973, July 21, 1993, as amended at 63FR 31932, June 11, 1998]

§ 524.1193 Ivermectin pour-on.(a) Specifications. Each milliliter of

solution contains 5 milligrams ofivermectin.

(b) Sponsors. (1) See No. 050604 in§ 510.600(c) of this chapter for use as inparagraph (d) of this section.

(2) See No. 059130 for use as in para-graphs (d)(1), (d)(2)(i), and (d)(3) of thissection.


(d) Conditions of use—(1) Amount. Onemilliliter per 22 pounds of body weight.

(2) Indications for use. (i) For cattle:It is used for the treatment and controlof: Gastrointestinal roundworms(adults and fourth-stage larvae)Ostertagia ostertagi (including inhibitedstage), Haemonchus placei,Trichostrongylus axei, T. colubriformis,Cooperia spp., Oesophagostomumradiatum; (adults) O. venulosum,Strongyloides papillosus, Trichuris spp.;lungworms (adults and fourth-stagelarvae) Dictyocaulus viviparus; cattlegrubs (parasitic stages) Hypodermabovis, H. lineatum; mites Chorioptesbovis, Sarcoptes scabei var. bovis; liceLinognathus vituli, Haematopinuseurysternus, Damalina bovis, Solenoptescapillatus; horn flies Haematobiairritans.

(ii) For cattle: It is also used to con-trol infections of gastrointestinalroundworms O. ostertagi, O. radiatum,H. placei, T. axei, Cooperia punctata, andC. oncophora for 14 days after treat-ment.

(3) Limitations. For use on skin sur-face only. Do not treat cattle within 48days of slaughter. Because a with-drawal time in milk has not been es-tablished, do not use in female dairycattle of breeding age. Drug has beenassociated with severe adverse reac-tions in sensitive dogs; therefore drugis not recommended for use in animals


303


other than cattle. Consult your veteri-narian for assistance in the diagnosis,treatment, and control of parasitism.

[55 FR 50551, Dec. 7, 1990, as amended at 62FR 38908, July 21, 1997; 62 FR 63271, Nov. 28,1997; 63 FR 44385, Aug. 19, 1998]

§ 524.1200 Kanamycin ophthalmic andtopical dosage forms.

§ 524.1200a Kanamycin ophthalmicointment.

(a) Specifications. The drug, which isin a suitable and harmless ointmentbase, contains 3.5 milligrams ofkanamycin activity (as the sulfate) pergram of ointment.


(c) Conditions of use. It is indicatedfor use in dogs in various eye infectionsdue to kanamycin sensitive bacteria. Itis used treating conditions such as con-junctivitis, blepharitis, dacryocystitis,keratitis, and corneal ulcerations andas a prophylactic in traumatic condi-tions, removal of foreign bodies, andintraocular surgery. Apply a thin filmto the affected eye three or four timesdaily or more frequently if deemed ad-visable. Treatment should be continuedfor at least 48 hours after the eye ap-pears normal. For use only by or on theorder of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]

§ 524.1200b Kanamycin ophthalmicaqueous solution.

(a) Specifications. The drug, which isin an aqueous solution including suit-able and harmless preservatives andbuffer substances, contains 10 milli-grams of kanamycin activity (as thesulfate) per milliliter of solution.


(c) Conditions of use. It is indicatedfor use in dogs in various eye infectionsdue to kanamycin sensitive bacteria. Itis used in treating conditions such asconjunctivities, blepharitis,dacryocystitis, keratitis, and cornealulcerations and as a prophylactic intraumatic conditions, removal of for-eign bodies, and intraocular surgery.Instill a few drops into the affected eyeevery 3 hours or more frequently ifdeemed advisable. Administer as fre-

quently as possible for the first 48hours, after which the frequency of ap-plications may be decreased. Treat-ment should be continued for at least48 hours after the eye appears normal.For use only by or on the order of a li-censed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]

§ 524.1204 Kanamycin sulfate, calciumamphomycin, and hydrocortisoneacetate.

(a) Specifications. (1) Calciumamphomycin is the calcium salt ofamphomycin. It conforms to the fol-lowing specifications:

(i) Its potency is not less than 863micrograms of amphomycin per milli-gram;

(ii) Its moisture content is not morethan 10 percent; and

(iii) Its pH in a 2-percent aqueoussuspension is 6.0 to 7.5.

(2) The drug is in a water-miscibleointment or cream base and each gramof ointment or cream contains: 5.0 mil-ligrams of kanamycin activity as thesulfate, 5.0 milligrams of amphomycinactivity as the calcium salt, and 10.0milligrams of hydrocortisone acetate.


(c) Conditions of use. (1) It is indicatedfor use in dogs in the following condi-tions associated with bacterial infec-tions caused by organisms susceptibleto one or both antibiotics: Acute otitisexterna, furunculosis, folliculitis, pru-ritus, anal gland infections, erythema,decubital ulcer, superficial wounds, andsuperficial abscesses.

(2) The ointment should be applied tothe affected areas of the skin at leasttwice daily. In severe or widespread le-sions it may be desirable to apply theointment more than twice daily. Aftersome improvement is observed, treat-ment can usually be reduced to oncedaily. Before application, hair in theaffected area should be closely clippedand the area should be thoroughlycleansed of crusts, scales, dirt, or otherdetritus. When treating infections ofthe anal gland, the drug should be in-troduced into the orifice of the glandand not through any fistulous tract. If


304

21 CFR Ch. I (4–1–00 Edition)§ 524.1240

no response is evident in 7 days, diag-nosis and therapy should be reevalu-ated.


[40 FR 13858, Mar. 27, 1975, as amended at 53FR 12512, Apr. 15, 1988; 53 FR 27851, July 25,1988; 64 FR 404, Jan. 5, 1999]

§ 524.1240 Levamisole.(a) Specifications. The drug contains

200 milligrams of levamisole per milli-liter of diethylene glycol monobutylether (DGME) solution.

(b) Sponsor. See 000061 and 010042 in§ 510.600(c) of this chapter.


(d) Conditions of use. Cattle—(1)Amount. 2.5 milliliters per 110 pounds(10 milligrams of levamisole per kilo-gram) of body weight as a single dosetopically to the back of the animal.

(2) Indications for use. Anthelminticeffective against stomach worms(Haemonchus, Trichostrongylus,Ostertagia), intestinal worms(Trichostrongylus, Cooperia,Nematodirus, Bunostomum,Oesophagostomum, Chabertia), andlungworms (Dictyocaulus).

(3) Limitations. Conditions of constanthelminth exposure may require re-treatment within 2 to 4 weeks after thefirst treatment. Cattle must not beslaughtered within 9 days followinglast treatment. Do not administer todairy animals of breeding age. Do nottreat animals before dipping or prior toexposure to heavy rain. Consult yourveterinarian for assistance in the diag-nosis, treatment, and control of para-sitism, and before using in severely de-bilitated animals.

[52 FR 10887, Apr. 6, 1987, as amended at 53FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19,1997]

§ 524.1376 2-Mercaptobenzothiazole so-lution.

(a) Specifications. The drug contains1.3 percent 2-mercaptobenzothiazole ina suitable solvent.


(c) Conditions of use—(1) Amount.Apply twice daily to affected area.

(2) Indications for use. For dogs as anaid in treating moist dermatitis and

hotspots and as first aid for scrapesand abrasions.

(3) Limitations. Clip hair from affectedarea before applying. If no improve-ment is seen within 1 week, consult aveterinarian.

[48 FR 15618, Apr. 12, 1983]

§ 524.1443 Miconazole nitrate cream;miconazole nitrate lotion;miconazole nitrate spray.

(a) Specifications. (1) The cream con-tains 23 milligrams of miconazole ni-trate (equivalent to 20 milligrams ofmiconazole base) per gram.

(2) The lotion contains 1.15 percent ofmiconazole nitrate (equivalent to 1percent miconazole base).

(3) The spray product consists of adispensing container, sprayer pump as-sembly, and lotion which contains 1.15percent of miconazole nitrate (equiva-lent to 1-percent miconazole base).

(b) Sponsor. See No. 000061 in§ 510.600(c) of this chapter for use ofcream, lotion, and spray; see No. 051259in § 510.600(c) of this chapter for use oflotion and spray.

(c) Conditions of use. (1) Miconazolenitrate is an antifungal agent for top-ical treatment of infections in dogs andcats caused by Microsporum canis,Microsporum gypseum, and Trichophytonmentagrophytes.

(2) Apply once daily by rubbing intoor spraying a light covering on the in-fected site and the immediate sur-rounding vicinity. Continue treatmentfor 2 to 4 weeks until infection is com-pletely eradicated as determined by ap-propriate laboratory examination.

(3) Accurate diagnosis of infecting or-ganism is essential. Identify by micro-scopic examination of a mounting ofinfected tissue in potassium hydroxidesolution or by culture on an appro-priate medium.

(4) If no improvement is observed in 2weeks, reevaluate diagnosis and ther-apy.

(5) Avoid contact with eyes since irri-tation may result.


[40 FR 13873, Mar. 27, 1975, as amended at 53FR 26242, July 12, 1988; 62 FR 55161, Oct. 23,1997; 62 FR 61626, Nov. 19, 1997]


305

Food and Drug Administration, HHS § 524.1484a

§ 524.1446 Milbemycin oxime solution.(a) Specifications. Each tube contains

0.25 milliliter of a 0.1 percent solutionof milbemycin oxime.


(c) Conditions of use—(1) Amount. Onetube administered topically into eachexternal ear canal as a single treat-ment.

(2) Indications for use. For the treat-ment of ear mite (Otodectes cynotis) in-festations in cats and kittens 8 weeksof age and older. Effectiveness is main-tained throughout the life cycle of theear mite.

(3) Limitations. Federal law restrictsthis drug to use by or on the order of alicensed veterinarian.

[65 FR 13905, Mar. 15, 2000]

§ 524.1451 Moxidectin.(a) Specifications. Each milliliter con-

tains 5 milligrams of moxidectin (0.5percent solution).



(d) Conditions of use–(1) Amount. 0.5milligrams moxidectin per kilogram(2.2 pounds) of body weight.

(2) Indications for use. Beef and non-lactating dairy cattle for treatmentand control of internal and externalparasites: gastrointestinal roundworms(Ostertagia ostertagi (adult and L4, in-cluding inhibited larvae), Haemonchusplacei (adult), Trichostrongylus axei(adult and L4), T. colubriformis (adult),Cooperia oncophora (adult), C. punctata(adult), Bunostomum phlebotomum(adult), Oesophagostomum radiatum(adult), Nematodirus helvetianus(adult)); lungworms (Dictyocaulusviviparus, adult and L4); cattle grubs(Hypoderma bovis, H. lineatum); mites(Chorioptes bovis, Psoroptes ovis (P.Communis var. bovis)); lice (Linognathusvituli, Haematopinus eurysternus,Solenopotes capillatus, Damalinia bovis);and horn flies (Haematobia irritans). Tocontrol infections and to protect fromreinfection with O. ostertagi for 28 daysafter treatment and with D. viviparusfor 42 days after treatment.

(3) Limitations. Apply topically alongthe top of the back from the withers to

the tailhead. Because a withdrawaltime for milk has not been established,do not use on female dairy cattle ofbreeding age. A withdrawal period hasnot been established for this producton preruminating calves. Do not use oncalves to be processed for veal. Consultyour veterinarian for assistance in thediagnosis, treatment, and control ofparasitism.

[63 FR 14036, Mar. 24, 1998]

§ 524.1465 Mupirocin ointment.(a) Specifications. Each gram contains

20 milligrams of mupirocin.(b) Sponsor. See No. 000069 in

§ 510.600(c) of this chapter.(c) Conditions of use—(1) Dogs:(i) Indications for use. Topical treat-

ment of bacterial infections of theskin, including superficial pyoderma,caused by susceptible strains of Staphy-lococcus aureus and Staphylococcusintermedius.

(ii) Limitations. Apply twice daily.Treatment should not exceed 30 days.Because of potential hazard ofnephrotoxicity due to polyethyleneglycol content, care should be exer-cised in treating deep lesions. Safety ofuse in pregnant or breeding animalshas not been determined. Not for oph-thalmic use. Federal law restricts thisdrug to use by or on the order of a li-censed veterinarian.

(2) [Reserved]

[53 FR 39085, Oct. 5, 1988, as amended at 56 FR50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

§ 524.1484 Neomycin sulfate oph-thalmic and topical dosage forms.

§ 524.1484a Neomycin sulfate oph-thalmic ointment.

(a) Specifications. Each gram of theointment contains 5 milligrams of neo-mycin sulfate equivalent in activity to3.5 milligrams of neomycin base.


(c) Conditions of use. (1) The drug isintended for use in dogs and cats forthe treatment of superficial ocular bac-terial infections limited to the con-junctival or the anterior segment ofthe eye.

(2) The drug is applied four timeseach day.


306

21 CFR Ch. I (4–1–00 Edition)§ 524.1484b

(3) The drug is applied by insertingthe tip of the tube beneath the lowerlid and by expressing a small quantityof ointment into the conjunctival sac.The tip of the tube should not come incontact with the eye surface.

(4) Severe infections should be sup-plemented by systemic therapy.

(5) Prolonged administration of thedrug may permit overgrowth of orga-nisms that are not susceptible to neo-mycin. If new infections due to bac-teria or fungi appear during therapy,appropriate measures should be taken.


[40 FR 13873, Mar. 27, 1975, as amended at 44FR 49666, Aug. 24, 1979]

§ 524.1484b Neomycin sulfate,isoflupredone acetate, tetracainehydrochloride, and myristyl-gamma-picolinium chloride, topicalpowder.

(a) Specifications. The product con-tains 5 milligrams of neomycin sulfate,equivalent to 3.5 milligrams of neomy-cin base, 1 milligram of isoflupredoneacetate, 5 milligrams of tetracaine hy-drochloride and .2 milligram ofmyristyl-gamma-picolinium chloridein each gram of the product in a specialadherent powder base.


(c) Conditions of use. (1) It is used inhorses, dogs, and cats in the treatmentor adjunctive therapy of certain earand skin conditions when such condi-tions are caused by or associated withneomycin-susceptible organisms and/orallergy. In addition the product is indi-cated as superficial dressing applied tominor cuts, wounds, lacerations, abra-sions, and for postsurgical applicationwhere reduction of pain and inflam-matory response is deemed desirable.The product may be used as a dustingpowder following amputation of tails,claws, and dew-claws and following eartrimming, castrating, and such sur-gical procedures asovariohysterectomies. The productmay also be used in the treatment ofacute otitis externa in dogs, acutemoist dermatitis and interdigital der-matitis in dogs.


[40 FR 13873, Mar. 27, 1975, as amended at 43FR 18172, Apr. 28, 1978]

§ 524.1484c Neomycin sulfate,isoflupredone acetate, tetracainehydrochloride ointment.

(a) Specifications. The drug contains 5milligrams of neomycin sulfate (equiv-alent to 3.5 milligrams of neomycinbase), 1 milligram of isoflupredone ace-tate, and 5 milligrams of tetracaine hy-drochloride in each gram of ointment.


(c) Conditions of use. (1) It is used intreating such conditions as acute otitisexterna in dogs and to a lesser degree,chronic otitis externa in dogs. It also iseffective in treating anal gland infec-tions and moist dermatitis in the dogand is a useful dressing for minor cuts,lacerations, abrasions, and post-sur-gical therapy in the horse, cat, anddog. It may also be used following am-putation of dewclaws, tails and claws,following ear trimming and castratingoperations.

(2) In treatment of otitis externa andother inflammatory conditions of theexternal ear canal, a quantity of oint-ment sufficient to fill the external earcanal may be applied one to threetimes daily. When used on the skin ormucous membranes, the affected areashould be cleansed, and a small amountof the ointment applied and spread orrubbed in gently. The involved areamay be treated one to three times aday and these daily applications con-tinued in accordance with the clinicalresponse.

(3) Tetracaine and neomycin have thepotential to sensitize. Care should betaken to observe animals being treatedfor evidence of hypersensitivity or al-lergy to the drug. If such signs arenoted, therapy with the drug should bestopped. Treatment should be limitedto the period when local anesthesia isessential to control self-inflicted trau-ma.


[40 FR 13873, Mar. 27, 1975, as amended at 43FR 18172, Apr. 28, 1978]


307

Food and Drug Administration, HHS § 524.1484f

1 These conditions are NAS/NRC reviewedand deemed effective. Applications for theseuses need not include effectiveness data asspecified by § 514.111 of this chapter, but mayrequire bioequivalency and safety informa-tion.

§ 524.1484d Neomycin sulfate, hydro-cortisone acetate, tetracaine hydro-chloride ear ointment.

(a) Specifications. The product con-tains 5 milligrams of neomycin sulfate,equivalent to 3.5 milligrams of neomy-cin base, 5 milligrams of hydro-cortisone acetate, and 5 milligrams oftetracaine hydrochloride in each gramof ointment.


(c) Conditions of use. (1) It is indicatedfor treating acute otitis externa and,to a lesser degree, chronic otitisexterna in dogs and cats. In treatmentof ear canker and other inflammatoryconditions of the external ear canal, aquantity of ointment sufficient to fillthe external ear canal may be appliedone to three times daily.1

(2) Tetracaine and neomycin have thepotential to sensitize. Care should betaken to observe animals being treatedfor evidence of hypersensitivity or al-lergy to the product. If such signs arenoted, therapy with the product shouldbe stopped. Incomplete response or ex-acerbation of corticosteroid responsivelesions may be due to the presence ofnonsusceptible organisms or to pro-longed use of antibiotic-containingpreparations resulting in overgrowth ofnonsusceptible organisms, particularlyMonilia.1

(3) Federal law restricts this drug touse by or on the order of a licensed vet-erinarian.1

[40 FR 13873, Mar. 27, 1975, as amended at 49FR 21922, May 24, 1984]

§ 524.1484e Neomycin sulfate and poly-myxin B sulfate ophthalmic solu-tion.

(a) Specifications. Each milliliter ofthe ophthalmic preparation contains5.0 milligrams neomycin sulfate (3.5milligrams neomycin base), and 10,000Units of polymyxin B sulfate.


(c) Conditions of use. (1) The drug isrecommended for the treatment of bac-terial infections associated with top-ical ophthalmological conditions suchas corneal injuries, superficial kera-titis, conjunctivitis, keratocon-junctivities, and blepharitis in the dog.

(2) The recommended dosage is 1 to 2drops per eye every 6 hours.

(3) In treating ophthalmological con-ditions associated with bacterial infec-tions the drug is contraindicated inthose cases in which microorganismsare nonsusceptible to the antibioticsincorporated in the drug.



§ 524.1484f Neomycin sulfate, prednis-olone acetate, tetracaine hydro-chloride eardrops.

(a) Specifications. The product con-tains 5 milligrams of neomycin sulfateequivalent to 3.5 milligrams of neomy-cin base, 2.5 milligrams of prednisoloneacetate, and 5 milligrams of tetracainehydrochloride in each milliliter of ster-ile suspension.


(c) Conditions of use. (1) It is useful intreating such conditions as acute otitisexterna and, to a lesser degree, chronicotitis externa in dogs and cats. It is in-dicated as treatment or adjunctivetherapy of certain ear conditions indogs and cats caused by or associatedwith neomycin-susceptible organismsand/or allergy. In otitis externa, 2 to 6drops may be placed in the external earcanal two or three times daily.1

(2) Incomplete response or exacer-bation of corticosteroid responsive le-sions may be due to the presence ofnonsusceptible organisms or to pro-longed use of antibiotic-containingpreparations resulting in overgrowth ofnonsusceptible organisms, particularlyMonilia. Thus, if improvement is notnoted within 2 or 3 days, or if redness,irritation, or swelling persists or in-creases, the diagnosis should be rede-termined and appropriate therapeuticmeasures initiated. Tetracaine and ne-omycin have the potential to sensitize.


308

21 CFR Ch. I (4–1–00 Edition)§ 524.1484g


Care should be taken to observe ani-mals being treated for evidence ofhypersensitivity or allergy. If suchsigns are noted, therapy should bestopped.1

(3) Federal law restricts this drug touse by or on the order of a licensed vet-erinarian.1

§ 524.1484g Neomycin sulfate-thiabendazole-dexamethasone solu-tion.

(a) Specifications. Each cubic centi-meter of neomycin sulfate-thiabendazole-dexamethasone solutioncontains: 40 milligrams ofthiabendazole, 3.2 milligrams of neo-mycin (from neomycin sulfate), and 1milligram of dexamethasone.


(c) Conditions of use. (1) The drug isrecommended for use as an aid in thetreatment of bacterial, mycotic, andinflammatory dermatoses and otitisexterna in dogs and cats.

(2) In treating dermatoses affectingareas other than the ear, the surface ofthe lesions should be well moistened(two to four drops per square inch)twice daily. In treating otitis externa,five to 15 drops of the drug should beinstilled in the ear twice daily. Thedrug is limited to 7 days maximum du-ration of administration.

(3) For use only by or on order of a li-censed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62FR 63271, Nov. 28, 1997]

§ 524.1484h Neomycin, penicillin, poly-myxin, hydrocortisone suspension.

(a) Specifications. Each milliliter ofsuspension contains 25 milligrams ofneomycin sulfate equivalent to 17.5milligrams of neomycin, 10,000 inter-national units of penicillin G procaine,5,000 international units of polymyxinB sulfate, 2 milligrams of hydro-cortisone acetate, and 1.25 milligramsof hydrocortisone sodium succinate.


(c) Special considerations. The labelingshall state: This medication containspenicillin. Allergic reactions in hu-mans are known to occur from topicalexposure to penicillin.

(d) Conditions of use—dogs—(1)Amount. Rub a small amount into theinvolved area 1 to 3 times a day. Afterdefinite improvement, it may be ap-plied once a day or every other day.

(2) Indications for use. Treatment ofsummer eczema, atopic dermatitis,interdigital eczema, and otitis externacaused by bacteria susceptible to neo-mycin, penicillin, and polymyxin B.

(3) Limitations. For use in dogs only.Shake drug thoroughly and clean le-sion before using. If redness, irritation,or swelling persists or increases, dis-continue use and reevaluate diagnosis.Federal law restricts this drug to useby or on the order of a licensed veteri-narian.

[59 FR 5105, Feb. 3, 1994]

§ 524.1484i Neomycin sulfate, hydro-cortisone acetate, sterile ointment.

(a) Specifications. The drug contains 5milligrams of neomycin sulfate, equiv-alent to 3.5 milligrams of neomycinbase, and 5 milligrams of hydro-cortisone acetate in each gram of oint-ment.1

(b) Sponsor. No. 000009 in § 510.600(c) ofthis chapter.

(c) Conditions of use. (1) Amount.Apply three or four times daily intothe conjunctival sac. With improve-ment, frequency may be reduced to twoor three times daily. For treatment ofear canker and other inflammatoryconditions of the external ear canal,fill external ear canal one to threetimes daily.1

(2) Indications for use. For treating in-fections, allergic, and traumatic kera-titis, conjunctivitis, acute otitisexterna and, to a lesser degree, chronicotitis externa in dogs and cats.1

(3) Limitations. All topical ophthalmicpreparations containingcorticosteroids, with or without anantimicrobial agent, are contra-indicated in the initial treatment ofcorneal ulcers. They should not be useduntil infection is under control andcorneal regeneration is well underway.Incomplete response or exacerbation ofcorticosteroid responsive lesions may


309

Food and Drug Administration, HHS § 524.1580c

be due to the presence of nonsuscep-tible organisms or to prolonged use onantibiotic-containing preparations re-sulting in overgrowth of nonsusceptibleorganisms, particularly Monilia. Fed-eral law restricts this drug to use by oron the order of a licensed veterinarian.1

[43 FR 40456, Sept. 12, l978]

§ 524.1484j [Reserved]

§ 524.1484k Neomycin sulfate, prednis-olone, tetracaine, and squalane top-ical-otic suspension.

(a) Specifications. Each milliliter ofsuspension contains 5 milligrams neo-mycin sulfate (equivalent to 3.5 milli-grams neomycin base), 2 milligramsprednisolone, 5 milligrams tetracaine,and 0.25 milliliter squalane.


(c) Conditions of use—(1) Amount. 2 to3 applications daily or as needed.

(2) Indications for use. Indicated foruse in dogs and cats for treating acuteotitis externa and as adjunctive ther-apy in management of chronic otitisexterna. The product may also be usedfor treating moist dermatitis in dogs.

(3) Limitations. Tetracaine and neo-mycin have the potential to sensitize.If signs of irritation or sensitivity de-velop, discontinue use. Prolonged useof this product may result in over-growth of nonsusceptible organisms. Ifnew infections due to bacteria or fungiappear during therapy, appropriatemeasures should be taken. Federal lawrestricts this drug to use by or on theorder of a licensed veterinarian.

[48 FR 5265, Feb. 4, 1983; 48 FR 8055, Feb. 25,1983]

§ 524.1580 Nitrofurazone ophthalmicand topical dosage forms.

§ 524.1580a [Reserved]

§ 524.1580b Nitrofurazone ointment.(a) Specifications. The drug contains

0.2 percent nitrofurazone in a water-soluble base.

(b) Sponsor. For use on dogs, cats, orhorses, see Nos. 000010, 000857, 000864,000069, 050749, 023851, and 051259 in§ 510.600(c) of this chapter. For use ondogs and horses, see No. 017135 in§ 510.600(c) of this chapter. For use on

horses, see No. 017153 in § 510.600(c) ofthis chapter.

(c) Conditions of use—(1) Indicationsfor use. For prevention or treatment ofsurface bacterial infections of wounds,burns, and cutaneous ulcers of dogs,cats, or horses.1

(2) Limitations. Apply directly on thelesion with a spatula or first place on apiece of gauze. Use of a bandage is op-tional. The preparation should remainon the lesion for at least 24 hours. Thedressing may be changed several timesdaily or left on the lesion for a longerperiod. For use only on dogs, cats, andhorses (not for food use). In case ofdeep or puncture wounds or seriousburns, use only as recommended byveterinarian. If redness, irritation, orswelling persists or increases, dis-continue use; consult veterinarian.1

[46 FR 43402, June 27, 1980, as amended at 49FR 6476, Feb. 22, 1984; 50 FR 49373, Dec. 2,1985; 52 FR 18691, May 19, 1987; 53 FR 32610,Aug. 26, 1988; 53 FR 40728, Oct. 18, 1988; 54 FR29544, July 13, 1989; 54 FR 37097, Sept. 7, 1989;55 FR 8462, Mar. 8, 1990; 55 FR 20455, May 17,1990; 56 FR 37473, Aug. 7, 1991; 56 FR 50653,Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997]

§ 524.1580c Nitrofurazone soluble pow-der.

(a) Specifications. The drug contains0.2 percent nitrofurazone in a water-soluble base.

(b) Sponsor. See Nos. 000010, 000069,and 050749 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount.Apply several times daily to the lesionor affected area from the plasticsqueeze bottle.

(2) Indications for use. For preventionor treatment of surface bacterial infec-tions of wounds, burns, skin ulcers, andabscesses after incision.1

(3) Limitations. In case of deep orpuncture wounds or serious burns, useonly as recommended by veterinarian.If redness, irritation, or swelling per-sists or increases, discontinue use; con-sult veterinarian. For use only on dogs,cats, and horses (not for food use).1

[45 FR 43402, June 27, 1980, as amended at 47FR 43368, Oct. 1, 1982; 48 FR 28984, June 24,1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542,July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995;62 FR 35077, June 30, 1997]


310

21 CFR Ch. I (4–1–00 Edition)§ 524.1580d


§ 524.1580d [Reserved]

§ 524.1580e Nitrofurazone ointmentwith butacaine sulfate.

(a) Specifications. The drug contains0.2 percent nitrofurazone and 0.5 per-cent butacaine sulfate in a water-solu-ble base.


(c) Conditions of use—(1) Indicationsfor use. For prevention or treatment ofsurface bacterial infections of ears,wounds, burns, and cutaneous ulcers ofdogs, cats, and horses.1

(2) Limitations. Apply directly on thelesion with a spatula or first place on apiece of gauze. Use of a bandage is op-tional. The preparation should remainon the lesion for at least 24 hours. Thedressing may be changed several timesdaily or left on the lesion for a longerperiod. For use only on dogs, cats, andhorses (not for food use). In case ofdeep or puncture wounds or seriousburns, use only as recommended by aveterinarian. If redness, irritation, orswelling persists or increases, dis-continue use; consult veterinarian.1

[49 FR 9417, Mar. 13, 1984]

§ 524.1600 Nystatin ophthalmic andtopical dosage forms.

§ 524.1600a Nystatin, neomycin,thiostrepton, and triamcinoloneacetonide ointment.

(a) Specifications. Each milliliter ofpetrolatum base or each gram of van-ishing cream base ointment contains:100,000 units of nystatin; neomycin sul-fate equivalent to 2.5 milligrams of ne-omycin base; 2,500 units ofthiostrepton; and 1.0 milligram oftriamcinolone acetonide.

(b) Sponsors. For petrolatum baseointments see 000031, 000069, 000332,025463, 051259, and 053501 in § 510.600(c) ofthis chapter. For vanishing cream baseointments see 051259 and 053501.

(c) Conditions of use—(1) Amount. (i)For topical dermatological use: Cleanaffected areas and remove any en-

crusted discharge or exudate, and applysparingly either ointment in a thinfilm.

(ii) For otic use: Clean ear canal ofimpacted cerumen, remove any foreignbodies such as grass awns and ticks,and instill three to five drops of petro-latum base ointment. Preliminary useof a local anesthetic may be advisable.

(iii) For infected anal glands and cys-tic areas: Drain gland or cyst and fillwith petrolatum base ointment.

(2) Indications for use. (i) Topically:Use either ointment in dogs and catsfor anti-inflammatory, antipruritic,antifungal, and antibacterial treat-ment of superficial bacterial infec-tions, and for dermatologic disorderscharacterized by inflammation and dryor exudative dermatitis, particularlyassociated with bacterial or candidal(Candida albicans) infections.

(ii) Otitis, cysts, and anal gland in-fections: Use petrolatum base ointmentin dogs and cats for the treatment ofacute and chronic otitis and interdig-ital cysts, and in dogs for anal glandinfections.

(3) Limitations. For mild inflamma-tions, use once daily to once a week.For severe conditions, apply initiallytwo to three times daily, decreasingfrequency as improvement occurs. Notintended for treatment of deep ab-scesses or deep-seated infections. Notfor ophthalmic use. Federal law re-stricts this drug to use by or on theorder of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43FR 29770, July 11, 1978; 50 FR 41490, Oct. 11,1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb.3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653,Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999]

§ 524.1600b Nystatin, neomycin,thiostrepton, and triamcinoloneacetonide ophthalmic ointment.

(a) Specifications. Each cubic centi-meter of ointment contains: 100,000units of nystatin, neomycin sulfateequivalent to 2.5 milligrams of neomy-cin base, 2,500 units of thiostrepton,and 1.0 milligram of triamcinoloneacetonide.


(c) Conditions of use. (1) The drug isrecommended for ophthalmic use as an


311

Food and Drug Administration, HHS § 524.1662b

anti-inflammatory, antipruritic,antifungal (Candida albicans), andantibacterial ointment for local ther-apy in keratitis and conjunctivitis incats and dogs and for infectious kerato-conjunctivitis (pink eye) in cattle.

(2) It is to be administered as follows:(i) For conjunctivitis and keratitis:

Apply one drop of ointment to the af-fected eye(s) two or three times daily.Treatment may be continued for up to2 weeks if necessary.

(ii) For bovine infectious kerato-con-junctivitis: Apply small line of oint-ment to the affected eye(s) once daily.Treatment may be continued for up to2 weeks if necessary.

(iii) Frequency of administration isdependent on the severity of the condi-tion. For mild inflammations, applica-tions may range from once daily toonce a week; for severe conditions thedrug may be applied as often as two tothree times daily. Frequency of treat-ment may be decreased as improve-ment occurs.


[40 FR 13873, Mar. 27, 1975, as amended at 50FR 41490, Oct. 11, 1985]

§ 524.1662 Oxytetracycline hydro-chloride ophthalmic and topicaldosage forms.

§ 524.1662a Oxytetracycline hydro-chloride and hydrocortisone spray.

(a) Specifications. Each 3-ounce unitof oxytetracycline hydrochloride andhydrocortisone spray contains 300 mil-ligrams of oxytetracycline hydro-chloride and 100 milligrams of hydro-cortisone with an inert freon propel-lant such that a 1-second spray treat-ment will deliver approximately 2.5milligrams of oxytetracycline hydro-chloride and 0.8 milligram of hydro-cortisone.


(c) Conditions of use. (1) The drug isindicated for relief of discomfort andcontinued treatment of many allergic,infectious, and traumatic skin condi-tions. The indications include preven-tion of bacterial infections in super-ficial wounds, cuts, and abrasions,treatment of allergic dermatoses, in-cluding urticaria, eczemas, insect

bites, and cutaneous drug reactions, in-fections associated with minor burnsand wounds, and nonspecific pruritusin dogs and cats.

(2) A small quantity should besprayed on the affected surface byholding the container about 6 inchesfrom the area to be treated and press-ing the nozzle for 1 or 2 seconds. Onlysufficient spray to coat the skin thinlyis necessary. The application of smallamounts at frequent intervals will givebest results. Before treating animalswith long or matted hair, it may benecessary to clip the affected area orspread the hairs to allow the medica-tion to contact the skin surface. Reliefmay be noted following the first or sec-ond treatment; however, treatmentshould not be discontinued too soonafter the initial favorable response hasbeen obtained.

(3) Keep away from eyes or other mu-cous membranes; avoid inhaling; usewith adequate ventilation; in case ofdeep or puncture wounds or seriousburns, consult a veterinarian.

§ 524.1662b Oxytetracycline hydro-chloride, polymyxin B sulfate oph-thalmic ointment.

(a) Specifications. Each gram of theointment contains oxytetracycline hy-drochloride equivalent to 5 milligramsof oxytetracycline and 10,000 units ofpolymyxin B sulfate.


(c) Conditions of use. (1) The drug isused for the prophylaxis and localtreatment of superficial ocular infec-tions due to oxytetracycline- and poly-myxin-sensitive organisms. These in-fections include the following: Ocularinfections due to streptococci,rickettsiae, E. coli, and A. aerogenes(such as conjunctivitis, keratitis, pink-eye, corneal ulcer, and blepharitis indogs, cats, cattle, sheep, and horses);ocular infections due to secondary bac-terial complications associated withdistemper in dogs; and ocular infec-tions due to bacterial inflammatoryconditions which may occur secondaryto other infectious diseases in dogs,cats, cattle, sheep, and horses.

(2) It is administered topically to theeye two to four times daily.


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21 CFR Ch. I (4–1–00 Edition)§ 524.1742

(3) Allergic reactions may occasion-ally occur. Treatment should be dis-continued if reactions are severe. Ifnew infections due to nonsensitive bac-teria or fungi appear during therapy,appropriate measures should be taken.

§ 524.1742 N-(Mercaptomethyl) phthal-imide S-(O,O-dimethylphosphorodithioate) emulsifiableliquid.

(a) Specifications. The emulsifiableliquid contains 11.6 percent N-(mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate).


(c) Conditions of use—(1) Methods ofapplication. Methods of application tocontrol the following conditions onbeef cattle:

To control/method of useDilution rate

(gal. drug: gal.of water)

Grubs:Dip ......................................................... 1:60Pour-on .................................................. 1:2Spray ..................................................... 1:49

Lice:Dip ......................................................... 1:60Pour-on .................................................. 1:2 or 1:5Spray ..................................................... 1:49 or 1:100

Hornflies:Dip ......................................................... 1:60Spray ..................................................... 1:49 or 1:100

Cattle Ticks:Dip ......................................................... 1:60 or 1:240Spray ..................................................... 1:49

Southern cattle ticks:Dip ......................................................... 1:60 or 1:240Spray ..................................................... 1:49

Scabies mites:.Dip ......................................................... 1:60

Lone Star Ticks:Dip ......................................................... 1:60Spray ..................................................... 1:49 or 1:100

(i) Dip vat procedure. (a) Prior tocharging vat, empty old contents andthoroughly clean the vat. Dip vatsshould be calibrated to maintain an ac-curate dilution. Add water, then drugto the vat according to the dilutionrate indicated in the table. Add superphosphate at a rate of 100 pounds per1,000 gallons of vat solution. Superphosphate is added to control the pH ofthe solution and ensure vat stability.Super phosphate is usually available atmost fertilizer dealers as 0–45–0 or 0–46–0. Stir the dip thoroughly, preferablywith a compressed air device; however,any form of thorough mixing is ade-quate. Re-stir vat contents prior to

each use. During the dipping operation,each time the dip’s volume is reducedby 1⁄8 to 1⁄4 of its initial volume, replen-ish with water and add the drug at arate of 1 gallon for each 50 or 200 gal-lons water added—depending on dilu-tion rate 1:60 or 1:240. Also add superphosphate as necessary to maintain pHbetween 4.5 and 6.5. Stir well and re-sume dipping. Repeat replenishmentprocess as necessary. For evaportion,add additional water accordingly. Foradded water due to rainfall, merely re-plenish dip with the product accordingto directions. If overflow occurs, eitheranalyze for drug concentration and ad-just accordingly or dispose of vat con-tents and recharge. Check pH aftereach addition of water or super phos-phate to assure proper pH controls.

(b) Dip maintenance. (1) With use ofdip vat tester, dipping may continue aslong as the drug concentration is main-tained between 0.15 and 0.25 percent,and the dip is not too foul for satisfac-tory use as indicated by foul odor orexcessive darkening (i.e., color changesfrom beige to very dark brown).

(2) Without use of dip vat tester, vatshould be emptied, cleaned, and re-charged each time one of the followingoccurs: When the dip has been chargedfor 120 days; when the dip becomes toofoul for satisfactory use, within the120-day limit; if the number of animalsdipped equals twice the number of gal-lons of the initial dip volume, withinthe 120-day limit.

(ii) Spray method. To prepare thespray, mix drug with water accordingto table and stir thoroughly. Apply thefresh mixture as a high-pressure spray,taking care to wet the skin, not justthe hair. Apply to the point of ‘‘run-off,’’ about 1 gallon of diluted spray peradult animal. Lesser amounts will per-mit runoff for younger animals.

(iii) Pour-on method. Dilute the drugwith water according to table by slow-ly adding water to the product whilestirring. Apply 1 ounce of the dilutedmixture per 100 pounds of body weight(to a maximum of 8 ounces per head)down the center line of the back.

(2) Timing of applications for cattlegrub control. For optimum cattle grubcontrol, it is important to treat assoon as possible after the heel fly sea-son, before the grub larvae reach the


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Food and Drug Administration, HHS § 524.1881b

gullet or spinal canal, as the rapid killof large numbers of larvae in these tis-sues may cause toxic side effects, suchas bloat, salivation, staggering, and pa-ralysis.

(3) Treatment regimens. (i) Control ofscabies mites requires two treatments,10 to 14 days apart.

(ii) Control of Lone Star Ticks andhornflies requires two treatments, 7days apart.

(4) Warnings. The drug is a cholin-esterase inhibitor. Do not use this drugon animals simultaneously or within afew days before or after treatment withor exposure to cholinesterase-inhib-iting drugs, pesticides, or chemicals.Do not apply within 21 days of slaugh-ter. For use on beef cattle only. Do nottreat sick, convalescent, or stressedcattle, or calves less than 3 months oldexcept in Federal or State eradicationprograms where immediate treatmentof all animals in an infested herd ismandatory. Be sure free access todrinking water is available to cattleprior to dipping. Do not dip excessivelythirsty animals. Do not dip animalswhen overheated. Repeat treatment asnecessary but not more often thanevery 7 to 10 days. Treatment for lice,ticks, hornflies, and scabies mites maybe made any time of the year exceptwhen cattle grub larvae are in the gul-let or spinal canal. Treatment for lice,ticks, and scabies mites may be madeany time 7 to 10 days following treat-ment for grubs. Do not treat grubswhen the grub larvae are in the gulletor spinal canal. Do not get in eyes, onskin, or on clothing. Do not breathespray mist. Wear rubber gloves, gog-gles, and protective clothing. In case ofskin contact, wash immediately withsoap and water; for eyes, flush withwater. Wash all contaminated clothingwith soap and hot water before re-use.

(d) Related tolerances. See 40 CFR180.261.

[40 FR 13873, Mar. 27, 1975, as amended at 46FR 27914, May 22, 1981; 48 FR 39607, Sept. 1,1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873,Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR5255, Feb. 2, 1998]

§ 524.1880 Prednisolone-neomycin sul-fate ophthalmic ointment.

(a) Specifications. Prednisolone-neo-mycin sulfate ophthalmic ointment

contains 2 milligrams prednisolone and5 milligrams neomycin sulfate (equiva-lent to 3.5 milligrams neomycin base)in each gram of ointment.


(c) Conditions of use. The drug is rec-ommended for use in superficial ocularinflammations or infections limited tothe conjunctiva or the anterior seg-ment of the eye of cats and dogs, suchas those associated with allergic reac-tions or gross irritants. A small quan-tity of the ointment should be ex-pressed into the conjunctival sac fourtimes a day for 7 days. After 7 days, ifclinical improvement is not noted, re-evaluation of the diagnosis should beconsidered. All topical ophthalmicpreparations containing corticosteroidswith or without an antimicrobial agentare contraindicated in the initial treat-ment of corneal ulcers. They shouldnot be used until the infection is undercontrol and corneal regeneration iswell underway. For use only by or onthe order of a licensed veterinarian.

§ 524.1881 Prednisolone acetate oph-thalmic and topical dosage forms.

§ 524.1881a [Reserved]

§ 524.1881b Prednisolone acetate-neo-mycin sulfate sterile suspension.

(a) Specifications. Prednisolone ace-tate-neomycin sulfate sterile suspen-sion contains 2.5 milligrams of prednis-olone acetate and 5 milligrams of neo-mycin sulfate (equivalent to 3.5 milli-grams of neomycin base) in each milli-liter of sterile suspension.


(c) Conditions of use. (1) The drug isindicated for treating infectious, aller-gic and traumatic keratitis and con-junctivitis, acute otitis externa, andchronic otitis externa in dogs and cats.

(2) For beginning treatment of acuteocular inflammations 1 or 2 drops maybe placed in the conjunctival sac 3 to 6times during a 24 hour period. Whenimprovement occurs, the dosage maybe reduced to 1 drop 2 to 4 times daily.In otitis externa, 2 to 6 drops may beplaced in the external ear canal 2 or 3times daily.

(3) All topical ophthalmic prepara-tions containing corticosteroids with


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21 CFR Ch. I (4–1–00 Edition)§ 524.1883


or without an anti-microbial agent arecontraindicated in the initial treat-ment of corneal ulcers. They shouldnot be used until infection is undercontrol and corneal regeneration iswell underway.


§ 524.1883 Prednisolone sodium phos-phate-neomycin sulfate ophthalmicointment.

(a) Specifications. Prednisolone so-dium phosphate-neomycin sulfate oph-thalmic ointment contains prednis-olone sodium phosphate equivalent to2.5 milligrams prednisolone 21-phos-phate and 5 milligrams neomycin sul-fate (equivalent to 3.5 milligrams neo-mycin base) in each gram of ointment.


(c) Conditions of use. (1) The drug isrecommended for use in superficial oc-ular inflammations or infections lim-ited to the conjunctiva or the anteriorsegment of the eye of cats and dogs,such as those associated with allergicreactions or gross irritants.1

(2) A small quantity of the ointmentshould be expressed into the conjunc-tival sac 4 times a day (at intervals of1 to 8 hours) for a few days until thereis a favorable response, then the fre-quency of application may be reducedto twice daily as long as the conditionremains under control. Treatment mayrequire from a few days to severalweeks.1

(3) All topical ophthalmic prepara-tions containing corticosteroids withor without an antimicrobial agent arecontraindicated in the initial treat-ment of corneal ulcers. They shouldnot be used until the infection is undercontrol and corneal regeneration iswell underway.1

(4) For use only by or on the order ofa licensed veterinarian.1

[40 FR 13873, Mar. 27, 1975, as amended at 62FR 63271, Nov. 28, 1997]

§ 524.1982 Proparacaine hydrochlorideophthalmic solution.

(a) Specifications. The drug is an aque-ous solution containing 0.5 percentproparacaine hydrochloride, 2.45 per-cent glycerin as a stabilizer, and 0.2percent chlorobutanol (choral deriva-tive) and 1:10,000 benzalkonium chlo-ride as preservatives.


(c) Special considerations. Thelongterm toxicity of proparacaine isunknown. Prolonged use may possiblydelay wound healing.

(d) Conditions of use. (1) The drug isindicated for use as a topical oph-thalmic anesthetic in animals. It isused as an anesthetic in cauterizationof corneal ulcers, removal of foreignbodies and sutures from the cornea,and measurement of intraocular pres-sure (tonometry) when glaucoma issuspected. Local applications may alsobe used as an aid in the removal of for-eign bodies from the nose and earcanal, as an accessory in the examina-tion and treatment of painful otitis, inminor surgery, and prior to catheter-ization.

(2) It is administered as follows:(i) For removal of sutures: Instill one

to two drops 2 or 3 minutes before re-moval of stitches.

(ii) For removal of foreign bodiesfrom eye, ear, and nose: For oph-thalmic use, instill three to five dropsin the eye prior to examination; forotic use, instill five to 10 drops in theear; for nasal use, instill five to 10drops in each nostril every 3 minutesfor three doses.

(iii) For tonometry: Instill one totwo drops immediately before measure-ment.

(iv) As an aid in treatment of otitis:Instill two drops into the ear every 5minutes for three doses.

(v) For minor surgery: Instill one ormore drops as required.

(vi) For catheterization: Instill twoto three drops with a blunt 20-gaugeneedle immediately before insertingcatheter.


[40 FR 13873, Mar. 27, 1975, as amended at 50FR 41490, Oct. 11, 1985]


315


§ 524.2098 Selamectin.(a) Specifications. Each milliliter con-

tains 60 or 120 milligrams ofselamectin.


(c) [Reserved](d) Conditions of use—(1) Amount. 2.7

milligrams of selamectin, topically,per pound (6 milligrams per kilogram)of body weight.

(2) Indications for use. Kills adult fleasand prevents flea eggs from hatchingfor 1 month, and it is indicated for theprevention and control of flea infesta-tions (Ctenocephalides felis), preventionof heartworm disease caused byDirofilaria immitis, and treatment andcontrol of ear mite (Otodectes cynotis)infestations in dogs and cats. Treat-ment and control of sarcoptic mange(Sarcoptes scabiei) and control of tick(Dermacentor variabilis) infestations indogs. Treatment of intestinalhookworm (Ancylostoma tubaeforme)and roundworm (Toxocara cati) infec-tions in cats. For dogs and cats 6 weeksof age and older.

(3) Limitations. Federal law restrictsthis drug to use by or on the order of alicensed veterinarian.

[64 FR 37401, July 12, 1999, as amended at 64FR 48707, Sept. 8, 1999]

§ 524.2101 Selenium disulfide suspen-sion.

(a) Specifications. The product con-tains 0.9-percent weight in weight (w/w)selenium disulfide (1-percent weight involume (w/v)).

(b) NAS/NRC status. These conditionsare NAS/NRC reviewed and found effec-tive. NADA’s for similar products forthese conditions of use need not in-clude effectiveness data as specified by§ 514.111 of this chapter, but may re-quire bioequivalency and safety infor-mation.

(c) Sponsors. See 000061, 017135, 023851,and 050604 in § 510.600(c) of this chapter.

(1) Indications for use. For use on dogsas a cleansing shampoo and as an agentfor removing skin debris associatedwith dry eczema, seborrhea, and non-specific dermatoses.

(2) Amount. One to 2 ounces per appli-cation.

(3) Limitations. Use carefully aroundscrotum and eyes, covering scrotum

with petrolatum. Allow the shampoo toremain for 5 to 15 minutes before thor-ough rinsing. Repeat treatment once ortwice a week. If conditions persist or ifrash or irritation develops, discontinueuse and consult a veterinarian.

[47 FR 53351, Nov. 26, 1982, as amended at 48FR 32762, July 19, 1983; 54 FR 36962, Sept. 6,1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025,Aug. 2, 1993; 63 FR 26981, May 15, 1998]

§ 524.2140 Squalane, pyrethrins andpiperonyl butoxide.

(a) Specifications. The drug contains25 percent squalane (hexame-thyltetracosane), 0.05 percentpyrethrins and 0.50 percent technicalpiperonyl butoxide.


(c) Conditions of use. (1) The drug isused for the treatment of ear mites indogs and cats.

(2) It is administered as follows: Catsand dogs 5–15 pounds body weight, 4 to5 drops in each ear daily. Dogs 16–30pounds body weight, 5 to 10 drops ineach ear daily. Dogs 30 pounds bodyweight and over 10 to 15 drops in eachear daily. The recommended treatmentis for 7 to 10 days with repeated treat-ment in 2 weeks if necessary.

§ 524.2350 Tolnaftate cream.

(a) Specifications. The drug contains 1percent tolnaftate (2-naphthyl-N-meth-yl-N-(3-tolyl) thionocarbamate) in ananhydrous cream base.


(c) Conditions of use. (1) The drug isindicated for treatment of ringwormlesions due to Microsporum canis andMicrosporum gypseum in dogs and cats.

(2) A small amount of the cream isapplied to the affected areas once ortwice a day for 2 to 4 weeks. The areasto be treated are first cleared ofexudate and the hair clipped if theareas are not already denuded. Thecream is massaged into each lesion andimmediate surrounding area until thecream is no longer visible.

(3) If no response is seen after 2weeks of treatment with the drug thediagnosis should be reviewed.


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21 CFR Ch. I (4–1–00 Edition)§ 524.2481


[43 FR 29289, July 7, 1978, as amended at 52FR 7833, Mar. 13, 1987]

§ 524.2481 Triamcinolone acetonidecream.

(a) Specifications. Triamcinoloneacetonide cream contains 0.1 percenttriamcinolone acetonide in an aqueousvanishing cream base.

(b) Sponsor. See No. 051259 and 053501in § 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug isrecommended for use on dogs as ananti-inflammatory, antipruritic, andantiallergic agent for topical treat-ment of allergic dermatitis and sum-mer eczema.

(2) The drug is applied by rubbinginto affected areas two to four timesdaily for 4 to 10 days.


[40 FR 13873, Mar. 27, 1975, as amended at 50FR 41490, Oct. 11, 1985; 65 FR 16817, Mar. 30,2000]

§ 524.2620 Liquid crystalline trypsin,Peru balsam, castor oil.

(a)(1) Specifications. The drug is a liq-uid for direct application or an aerosolpreparation formulated so that eachgram delivered to the wound site con-tains 0.12 milligram of crystallinetrypsin, 87.0 milligrams of Peru bal-sam, and 788.0 milligrams of castor oil.


(b)(1) Specifications. The drug is a liq-uid for direct application or an aerosolpreparation formulated so that eachgram delivered to the wound site con-tains 0.1 milligram of crystallinetrypsin, 72.5 milligrams of Peru bal-sam, and 800 milligrams of castor oil.


(c) Conditions of use. The drug is usedas an aid in the treatment of externalwounds and assists healing by facili-tating the removal of necrotic tissue,exudate and organic debris.

[40 FR 13873, Mar. 27, 1975, as amended at 41FR 56307, Dec. 28, 1976; 50 FR 9800, Mar. 12,1985; 54 FR 25565, June 16, 1989; 56 FR 37474,Aug. 7, 1991]

§ 524.2640 Tylosin, neomycin eye pow-der.

(a) Specifications. Tylosin is the anti-biotic substance produced by growth ofStreptromyces fradiae or the same anti-biotic substance produced by any othermeans. Tylosin, present as the tartratesalt, conforms to the appropriate anti-biotic standard. Tylosin contains atleast 95 percent tylosin as a combina-tion of tylosin A, tylosin B, tylosin C,and tylosin D of which at least 80 per-cent is tylosin A as determined by amethod entitled ‘‘Determination ofFactor Content in Tylosin by High Per-formance Liquid Chromatography,’’which is incorporated by reference.Copies are available from the DocketsManagement Branch (HFA–305), Foodand Drug Administration, rm. 1–23,12420 Parklawn Dr., Rockville, MD20857, or available for inspection at theOffice of the Federal Register, 800North Capitol Street, NW., suite 700,Washington, DC 20001.


(c) Conditions of use. (1) It is used incattle for the treatment of pinkeye (in-fectious keratoconjunctivitis).

(2) It is administered by holding theeyelids open and dusting powder intoboth eyes. The treatment is repeateddaily for up to 7 days depending on theseverity of the infection. Affected ani-mals should be protected from directsunlight, dust, and flies. In an affectedherd, all animals with or without signsof the disease should receive at leastone treatment.

(3) If there is severe eye damage or ifthe condition persists or increases, dis-continue administering the drug andconsult a veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 50FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28,1994]

PART 526—INTRAMAMMARYDOSAGE FORMS

Sec.526.88 Amoxicillin trihydrate for

intramammary infusion.526.363 Cephapirin benzathine.526.365 Cephapirin sodium for

intramammary infusion.526.464 Cloxacillin intramammary dosage

forms.


289 part 524—ophthalmic and top- ical dosage form new ani

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