ADOLIN 0.1% CREAM AND GEL ®CompositionActive ingredients: adapalene 0.1%IndicationsADOLIN is indicated for the topical treatment of acne VULGARIS.Dosage AdministrationADOLIN should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes. During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.StorageStore at controlled room temperature 20° - 25º C (68º - 77º F).PackagingADOLIN 0.1% is supplied in 30 gm.:

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AVALON DIAPER RASH CREAM ®Compositionzinc oxide 8% w/w , dexapanthenol 2% w/w, cetrimide 0.5% w/w, emulgin B2, castor oil, olive oil, cetostearyl alcohol, paraffin oil ,magnesium sulphate, perfume and waterIndicationsSoothe and remove diaper rash quickly, also it has an antibacterial effect.PackagingAvailable in 50 ml and 100 ml aluminum tubes

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AVALON POVIDONE-IODINE SHAMPOO ®CompositionPovidone-Iodine U.S.P. 7.5% w/vMechanism of ActionPovidone Iodine is an Iodine complex with Povidone (polyvinyl-pyrrolidone). Like Iodine the solution of the Iodine complex is bactericidal, fungicidal, virucidal, and trichomonacidal without the staining and irritating effect of the Iodine solution. Also the complex has long duration of action due to the continuous release of the free elemental Iodine from the complex.IndicationsAVALON Povidone Iodine shampoo is used for:- Damaged or chemically treated hair.- Controls dandruff and remove itching.- Seborrheic conditions of the scalp associated with erythema, scaling, exfoliation, pityriasis and pruritus, and cases of severe dandruff.- As a germicidal skin cleanser for prophylaxis of recurrent furunculosis and acute inflammatory skin lesions.ContraindicationsContraindicated for patients with thyroid disorders.Contraindicated for patients with known hypersensitivity to Iodine.Side EffectsIt is rare, may include local hypersensitivity.PrecautionsIf irritation, redness or swelling develops, stop the medication. Regular use should be avoided in patients on concurrent lithium therapyPregnancy and LactationConsult your physician before use in case of pregnancy and lactating mothers.Direction of UseRemove jewelry, wet the hair with water, and apply a sufficient amount (10-15ml) on the scalp and hair, using a warm water to lather. Rinse and repeat, massaging the scalp gently. Allow lather to remain for at least 5 minutes on the scalp. Work up lather then rinse thoroughly.Dosage AdministrationTwice weekly for 6 to 8 weeks, then once weekly or as directed by the physician.StorageStore below 30ºc. Protect from light.PackagingPlastic bottle of 125 ml.For external use onlyAvoid contact with the eyes

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AVALON WHITENING CREAM ®GeneralHydroquinone 1.9%CompositionEach gram contains 19 mg of Hydroquinone USP, Vitamine C, vitamine E, Emulgin B2, Cetostearyl Alcohol, Paraffin Oil, Benzoic Acid, Glycerine Propylene Glycol, Sodium Lauryl Sulfate, Citric Acid, Sodium Metabisulfite, Octyl Methoxy Cinnamate and Purified Water.PharmacologyHydroquinone application to skin provides depigmentation by inhibition of enzymatic oxidation of tyrosinase to 3,4 dihydroxyphylalanine.IndicationsWhitening cream is indicated for the bleaching of melanin hyperpigmentation. Its formula provides gentle and safe way to lighten the skin. ContraindicationsWhitening cream should not be used for patients who are sensitive to any of its components.Side EffectsNo systemic adverse reactions have been reported.If patient feels any hypersensitivity, discontinue medication and consult your physician

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AVOBAN 2% OINTMENT ®CompositionEach gram of AVOBAN ointment contains 20 mg of mupirocin in white translucent, water soluble polyethylene glycol base.PropertiesPharmacodynamicsAVOBAN ointment is topical antibacterial agent active against those organisms responsible for the majority of skin infections, eg. Staphylococcus aureus including methicillin –resistant strains, other staphylococci and streptococci,It is also active against some gram –ve pathogens such as haemophilus influenza.PharmacokineticsAbsorptionAVOBAN penetrates the intact skin but absorption is low.ExecrationSystemically absorbed AVOBAN ointment is rapidly metabolised to inactive metabolite form which is monic acid and quickly execrated by the kidneys.IndicationsBacterial skin infections e.g impetigo, folliculitis and furunculosis.ContraindicationsHyper sensitivity to AVOBAN ointment or other ingredients of the base.Side EffectsBurning localised to the area of application, itching erythema, stinging and dryness.Same like other antibiotic the prolonged use of AVOBAN can lead to overgrowth of non susceptible organisms including fungi.PrecautionsAVOBAN is not suitable for the ophthalmic or intra-nasal use, avoid use to the eye.In common with other polyethylene glycol-based ointments , AVOBAN should be used with caution if there is evidence of moderate or

severe renal impairment.

Pediatric use Safety and efficacy of Mupirocin 2% have been established in the range of 2month to 16 years.

Pregnancy and LactationCategory B. No data is available if Mupirocin is secreted in human milk.Dosage AdministrationAVOBAN is applied 3 times daily for 10 days , the area can be covered by dressing , patients not showing response within 3-5 days should be re- evaluated StorageStore below 30°CPackagingAVOBAN ointment is available in 15 & 30 gm aluminium tubes.

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AVOCAINE SPRAY ®GeneralLidocaine 10% w/wDescriptionEach gram of Avocaine 10% spray contains 100mg of Lidocaine base (10mg/dose)PropertiesPharmacodynamicAvocaine 10% Spray, like other local anesthetics, causes a reversible blockade of impulse propagation along nerve fibers by preventing the inward movement of sodium ions through the nerve membrane. Local anesthetics of the amide-type are thought to act within the sodium channels of the nerve membrane. Local anesthetics drugs may also have similar effects on excitable membranes in the brain and myocardium. If excessive amounts of the drug reach the systemic circulation rapidly, symptoms and signs of toxicity appear, emanating from the central nervous and cardiovascular system. Central nervous system toxicity usually precedes the cardiovascular effects since it occurs at lower plasma concentrations. Direct effects of local anesthetics on the heart include slow conduction, negative inotropism and eventually cardiac arrest.PharmacokineticLidocaine is absorbed following topical administration to mucous membranes; its rate and extent of absorption being dependent upon the concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anesthetic agents following topical application is most rapid after intratracheal and bronchial administration. Lidocaine is also well absorbed from the gastrointestinal tract, although little of the intact drug appears in the circulation because of biotransformation in the liver. The plasma protein binding of lidocaine is dependent on the drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 microgram of free base per ml, 60 to 80 percent of lidocaine is protein-bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Lidocaine is metabolised rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The elimination half-life of lidocaine following an intravenous bolus injection is typically 1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolised, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 microgram free base per ml.IndicationsFor the prevention of pain associated with the following procedures:Dental Practice

Before injections, dental impression, X-ray photography, removal of calculus. Introduction of instruments, tubes and catheters into the respiratory and digestive tract Provides surface anesthesia for the oropharyngeal and tracheal areas to reduce reflex activity, attenuate hemodynamic response and to facilitate insertion of the tube or the passage of instruments during endotracheal intubation, laryngoscopy, bronchoscopy and oesophagoscopy. ObstetricsDuring the final stages of delivery and before episiotomy and perineal suturing as supplementary pain control.Otorhinolaryngology – Puncture of the maxillary sinus and minor surgical procedures in the nasal cavity, pharynx and epipharynx. - Paracentesis. ContraindicationsKnown history of hypersensitivity to local anesthetics of the amide type or to any other components of the spray solution.Side EffectsIn extremely rare cases amide-type local anesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock). Local irritation at the application site has been described. Following application to laryngeal mucosa before endotracheal intubation, reversible symptoms such as “sore throat”, “hoarseness” and “loss of voice” have been reported. The use of Avocaine 10% Spray provides surface anesthesia during an endotracheal procedure but does not prevent post-intubation soreness. Systemic adverse reactions are rare and may result from high plasma levels due to excessive dosage or rapid absorption (e.g. following application to areas below the vocal chords) or from hypersensitivity, idiosyncrasy or reduced tolerance on the part of the patient. Such reactions involve the central nervous system and/or the cardiovascular system. CNS reactions are excitatory and/or depressant and may be characterized by nervousness, dizziness, convulsions, unconsciousness and possibly respiratory arrest. The excitatory reactions may be very brief or may not occur at all, in which case the first manifestations of toxicity may be drowsiness, merging into unconsciousness and respiratory arrest. Cardiovascular reactions are depressant and may be characterized by hypotension, myocardial depression, bradycardia and possibly cardiac arrest.PrecautionsExcessive dosage or short intervals between doses, may result in high plasma levels and serious adverse effects. Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Avocaine 10% Spray should be used with caution in patients with traumatized mucosa and/or sepsis in the region of the proposed application. If the dose or site of administration is likely to result in high blood levels, Avocaine 10% Spray, in common with other local anesthetics, should be used with caution in patients with epilepsy, cardiovascular disease and heart failure, impaired cardiac conduction, bradycardia, severe renal dysfunction, impaired hepatic function and in severe shock. Avocaine 10% Spray should also be used with caution in the elderly and patients in poor general health. In paralyzed patients under general anesthesia, higher blood concentrations may occur than in spontaneously breathing patients. Unanalyzed patients are more likely to swallow a large proportion of the dose, which then undergoes considerable first-pass hepatic metabolism following absorption from the gut. The oropharyngeal use of topical anesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. Avoid contact with the eyes. Patients treated with antiarrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. Avocaine 10% Spray should not be used on cuffs of endotracheal tubes (ETT) made of plastic. Avocaine 10% Spray base in contact with both PVC and non-PVC cuffs of endotracheal tubes may cause damage of the cuff. This damage is described as pinholes, which may cause leakage that could lead to pressure loss in the cuff.Pregnancy and LactationIn considering that a large number of pregnant women and women of child-bearing age have been given lidocaine. No specific disturbances to the reproductive process have so far been reported, e.g. no increased incidence of malformations. Like other local anesthetics lidocaine may enter the mother's milk, but in such small amounts that there is generally no risk of this affecting the neonate.Effects on ability to drive and use machinesDepending on the dose, local anesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.OverdosageAcute systemic toxicityToxic reactions originate mainly in the central nervous and the cardiovascular systems. Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are circumoral paraesthesia, numbness of the tongue, light-headedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of generalized convulsions. Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with normal respiration. In severe cases, apnea may occur. Acidosis increases the toxic effects of local anesthetics. Cardiovascular effects are only seen in cases with high systemic concentrations. Severe hypotension, bradycardia, arrhythmia and cardiovascular collapse may be the result in such cases. Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anesthetic or is heavily sedated with drugs such as a benzodiazepine or barbiturate. Recovery is due to redistribution and metabolism of the local anesthetic drug from the central nervous system. Recovery may be rapid unless large amounts of the drug have been administered. Treatment of acute toxicityThe objectives of treatment are to maintain oxygenation, stop convulsions and support the circulation. The necessary drugs and equipment should be immediately available. Ventilation should be maintained with oxygen by assisted or controlled respiration as required. An anticonvulsant should be given i.v. if the convulsions do not stop spontaneously in 15–20 sec. Thiopentone 100-150mg i.v. will abort the convulsions rapidly. Alternatively, diazepam 5-10mg i.v. may be used, although its action will be slow. Suxamethonium will stop the muscle convulsions rapidly, but will require tracheal intubation and artificial ventilation, and should only be used by those familiar with these procedures. If cardiovascular depression is evident (hypotension, bradycardia), ephedrine 5–10 mg i.v. should be given and repeated, if necessary, after 2–3 minutes. Should circulatory arrest occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance, since hypoxia and acidosis will increase the systemic toxicity of local anesthetics. Adrenaline 0.1-0.2 mg as intravenous or intracardiac injections should be given as soon as possible and repeated if necessary. Children should be given doses commensurate with their age and weightDrug InteractionsAvocaine 10% Spray should be used in caution with patients receiving agents structurally related to local anesthetics, e.g. tocainide, since the toxic effects are additive.Dosage AdministrationAvocaine 10% Spray is intended for use on mucous membranes and provides efficient surface anesthesia, which lasts for approximately 10-15 minutes. The anesthesia usually occurs within 1-5minutes, depending on the area of application. The following dosage

recommendations should be regarded as a guide; the clinician's experience and knowledge of the patient's physical status are of importance in calculating the proper required dose. As with any local anesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated or elderly patients and children over 12 years should be given doses commensurate with their age and physical condition. In children less than 12 years of age the dose should not exceed 3mg/Kg. and when used mainly in the larynx and trachea the dose should be reduced to 1.5 mg/Kg. In children less than 3 years of age less concentrated lidocaine solutions are recommended. Each activation of the metered dose valve delivers 10 mg lidocaine base. It is unnecessary to dry the site prior to application. No more than 20 spray applications should be used in any adult to produce the desired anesthetic effect. The number of sprays depend on the extent of the area to be anaesthetized. Dental practice 1–5 applications to the mucous membranes. Otorhinolaryngology 3 applications for puncture of the maxillary sinus. During delivery Up to 20 applications (200 mg lidocaine base). Introduction of instruments and catheters into the respiratory and digestive tract Up to 20 applications (200 mg lidocaine base) for procedures in pharynx, larynx, and trachea.

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AVOCIN 1% ®General(clindamycin phosphate topical solution, concentration equivalent to 10 mg clindamycin per 1 ml alcohol and water solution.CompositionAVOCIN 1% Topical Solution and AVOCIN 1% Topical solution contain clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per milliliter.AVOCIN 1% Topical Solution applicator is designed to provide facility to use the medication.Clindamycin Phosphate molecule:

Proper Name: Clindamycin Phosphate molecular weight is 504.97 g/mol.PropertiesClindamycin is a white to off-white, hygroscopic, crystalline powder. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol , propylene glycol, and water as solvent. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D galactooctopyranoside 2-(dihydrogen phosphate).Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the anti bacterially active clindamycin. Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin.Safety of clindamycin in in vivo concentrations:Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of AVOCIN 1% Topical Solution for 4 weeks was 597 mcg/g of comedonal material (range 0–1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4mcg/mL).Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.IndicationsAVOCIN 1% Topical Solution is indicated in the treatment of acne vulgaris.In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.(See CONTRAINDICATIONS, WARNINGS and Side effects.)ContraindicationsAVOCIN 1% Topical Solution, is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.Side EffectsIn 18 clinical studies of various formulations of AVOCIN 1% using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events. Number of Patients Reporting Events Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin.Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.PrecautionsOrally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death.

Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.Studies indicate a toxin(s) produced by clostridia is one primary cause of antibioticassociated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus.Endoscopic examination may reveal pseudomembranous colitis.Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severediarrhea.Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile.The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.GeneralAVOCIN 1% Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.AVOCIN 1% should be prescribed with caution in atopic individuals.Pregnancy and LactationPregnancy: Teratogenic effects—Pregnancy Category BReproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.It is not known whether clindamycin is excreted in human milk following use of AVOCIN 1%. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Pediatric UseSafety and effectiveness in pediatric patients under the age of 12 have not been established.Geriatric UseClinical studies for Avocin 1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.Drug InteractionsClindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.Dosage AdministrationApply a thin film of AVOCIN 1% Topical Solution, twice daily to affected area. Keep in a tightly closed container.StorageStore at controlled room temperature 15°c to 30°C.Protect from freezing.PackagingAVOCIN 1% Topical Solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in:30 ml applicator bottle.

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AVOCIN VAGINAL CREAM ®CompositionAvocin VC contains the following per gram: Clindamycin phosphate equivalent to clindamycin base: 20 mgBenzyl alcohol (preservative): 1%m/mPropertiesPharmacological Action Clindamycin phosphate is a synthetic antibiotic produced from lincomycin.Mechanism of action Clindamycin phosphate is hydrolysed in vivo to clindamycin, which inhibits bacterial protein synthesis. It binds to the 50S subunit of the bacterial ribosome and thereby prevents peptide bond formation.Microbiology Clindamycin is an antimicrobial agent which has been shown to have in vitro activity against the following organisms which are associated with bacterial vaginosis:Garderella vaginalisMobiluncus sppBacteroides sppMycoplasma hominisPeptostreptococcus sppPharmacokinetics Following once a day dosing of 100 mg of vaginally administered clindamycin phosphate, at a concentration equivalent to 20 mg of clindamycin per gram of cream, peak serum clindamycin levels average 20 ng/mL (range, 3 to 93  ng/mL) in normal volunteers. Approximately 3% (range, 0,1 to 7%) of the administered dose is absorbed systemically. In women with bacterial vaginosis, the amount of clindamycin absorbed following vaginal administration of 5 grams of Avocin VC (clindamycin 20 mg/g) is 4% (range, 0,8 to 8%) which is approximately the same as in normal volunteers.IndicationsAvocin VC is indicated in the treatment of symptomatic bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, Corynnebacterium vaginitis or anaerobic vaginosis) in non-pregnant women. Other pathogens commonly associated with vulvovaginitis e.g. Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis, Neisseria gonorrhoeae and Herpes simplex virus should be ruled out by appropriate methods.ContraindicationsAvocin VC is contraindicated in patients with a history of hypersensitivity to clindamycin or lincomycin.Pregnancy and lactation, as safety has not been demonstrated.

Side EffectsVaginal irritation or itching increased white discharge from the vagina, dizziness, headache, heartburn, nausea, vomiting, constipation, pain in the lower abdomen, diarrhea, skin rash and urticaria.PrecautionsThe use of clindamycin may result in the overgrowth of non-susceptible organisms particularly yeasts (like Candida albicans).Clindamycin has been associated with diarrhoea and in some cases pseudomembranous colitis. Minimal absorption (approximately 4%) occurs following the use of clindamycin phosphate cream intravaginally; however, if significant or prolonged diarrhoea occurs the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary. Safety in pregnancy has not been established. Safety in lactation has not been established.Drug InteractionsCross-resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin in vitro.IncompatibilitiesAvocin VC contains mineral oil that may weaken latex or rubber products, such as condoms or vaginal contraceptive diaphragms, and make them less effective as a barrier method of contraception or as protection from sexually transmitted diseases. The use of such products within 72 hours following treatment with Avocin VC is not recommended.Dosage AdministrationThe recommended dose is one applicator full (approximately 5 grams, which contains approximately 100 mg of clindamycin phosphate) of cream intravaginally, preferably at bedtime, for 3 to 7 consecutive days.Concomitant use with other intra-vaginal products is not recommended.Directions for use

1. Plastic disposable applicators are provided with this package. They are designed to allow proper vaginal administration of the cream.

2. Remove cap from cream tube. Screw a plastic applicator on the threaded end of the tube.

3. Rolling tube from the bottom, squeeze gently and force the medication into the applicator. The applicator is filled when the plunger reaches its pre-determined stopping point.

4. Unscrew the applicator from the tube and replace the cap.

5. While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort.

6. Slowly push the plunger until it stops.

7. Carefully withdraw applicator from the vagina, and discard applicator.StorageStore at room temperature (15 - 30°C). Protect from freezing. Keep out of reach of children.PackagingCream containing 2% clindamycin base (as the phosphate), intended for intravaginal use. Avocin VC is packaged in a 40  gram tube, accompanied by 7 disposable applicators. Each applicator full of cream (i.e one dose), contains approximately 5  grams of cream (100 mg of clindamycin).

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AVOCOM 0.1% ®GeneralCream & OintmentMometasone Fuorate U.S.P 0.1% w/wFor dermatologic use only.CompositionEach gram of Avocom 0.1% cream and ointment contains 1 mg of Mometasone furoate U.S.P and Dexapanthenol.PropertiesPharmacodynamicsMometazone is a synthetic corticosteroid, which has an anti-inflammatory, antipruritic and vasoconstrictive properties. PharmacokineticsSystemic absorption of topical corticosteroids will be increased if extensive body surface areas treated, so suitable precaution should be taken as long as when long-term use is anticipated especially in infants and children.IndicationsAvalon mometazone cream and ointment 0.1% are used for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, such as psoriasis and atopic dermatitis.Contraindications

Avalon mometazone cream and ointment 0.1% are contraindicated in patients who have sensitivity to mometazone or any other ingredients or excipients or any other corticosteroids.Side EffectsVery rare adverse reactions have been reported with Avalon mometazone cream 0.1%, include paresthesia, pruritus, and signs of skin atrophy. Rare adverse reactions have been reported with Avalon mometazone ointment 0.1% include burning, pruritus, tingling and signs of skin atrophy. With the usage of other topical corticosteroids the following local adverse reactions have been reported, irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae and mammillaria.PrecautionsIf irritation develops with the use of Avalon mometazone cream and ointment 0.1% the treatment should be stopped and start an appropriate therapy. In the presence of an infection, use antifungal or antibacterial agent. And if there is no response the Avalon mometazone cream and ointment 0.1% should be stopped until the infection is controlled. Any of the side effects that have been reported with the use of systemic corticosteroid (including adrenal suppression) may occur with topical corticosteroids, especially in infants and children. Excessive, prolonged use of corticosteroids can suppress pituitary adrenal function resulting in secondary adrenal insufficiency.Pediatric usePediatric patients have a larger skin surface area to body weight ratio than mature patients, so they demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary axis suppression and Cushing‘s syndrome. Use of topical corticosteroids for children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic Use corticosteroids in children may interfere with their development and growth.Pregnancy and LactationSince there is no available data about using Avalon mometazone cream or ointment 0.1% for pregnant women, physician should take in

consideration benefit-risk ratio. Corticosteroids should not be used on pregnant patients in large amounts or for prolonged periods of time.

It is not known whether topical application of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Decision to stop feeding or stop the medication should be taken taking in consideration the importance of the drug to the mother..Dosage AdministrationApply a thin film of Avalon mometazone cream or ointment 0.1% to the affected skin areas once daily, massage gently and thoroughly Do not expose to direct sunlight after use.StorageStore below 30ºcPackagingAvocom 0.1% cream is available in 30g aluminum tube.

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AVODYL MOUTH WASH ®GeneralCompositionDomiphen bromide 0.01%IndicationsEffectively prevents dental plaque formation. Treatment of gingivitis and periodontitis. Control of mouth ulcers and oral thrush. Provide a good oral hygienic condition.PrecautionsFor external use only. Do not swallow.Dosage AdministrationRinse thoroughly with 10 ml twice daily and before bed time.StorageStore below 30ºc away from light.

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AVOGAIN 2% &5% ®GeneralDescriptionAVOGAIN 2% &5% solution is a topical solution for hair growth stimulation, and is also used to prevent hair loss and management of thinning hair.CompositionMinoxidil 2% & 5% topical solutionPharmacologyMinoxidil 2% & 5% is poorly absorbed from normal intact skin. Only about 1.4% of the dose may be absorbed by the systemic circulation. The drug's percutaneous absorption rate controls the level of serum minoxidil resulting from topical application.After cessation of the minoxidil topical treatment, about 95% of the systematically absorbed minoxidil is eliminated through renal excretion within four days.IndicationsAVOGAIN 2% &5% solution formula provides the patient with a gentle and safe way for hair growth stimulation and treatment of hair loss. And used in cases such as:Alopecia androgenetica (baldness of the vertex in male, diffuse hair loss or thinning of the hair in the frontoparietal areas in females.)Alopecia areata (inflammatory patchy loss of the hair as in the beard and scalp).ContraindicationsAVOGAIN is contraindicated in patients who are may have sensitivity to the drug or to any of its components. No data available on the safety and efficacy in patients below 18 years or above 65 years.Side EffectsThe most frequently encountered adverse effects are dermatitis of the scalp. The most common reactions include irritation, flushing, dermatitis, dry skin and burning sensations.Rarely reported adverse effects include allergic reactions, dizziness, tingling sensation, light headedness, weakness, neuritis, oedema, eye irritation, altered taste, blood pressure changes, ear infection and visual disturbances.Precautions

For topical use only. Keep out of reach of children. Use according to the instructions. Wash hands thoroughly after use. Avogain 2% & 5% solution may cause burning and irritation of the eye, in case of accidental contact with the eye or abraded skin or mucous membranes the area should be washed thoroughly with copious amounts of cool tap water.Pregnancy and LactationUsed under medical supervision for pregnant women and new mothers.OverdosageNo over dose cases have been reported for Avogain 2% & 5% solution as it is intended for external topical use only. In case of accidental ingestion, it may has an effect on the cardiovascular system such as tachycardia which can be controlled by administration of beta-adrenergic blocking agents or hypotension which can be managed by administration of intravenous normal saline and finally fluid retention which can be controlled with diuretic medications.Dosage AdministrationDry both scalp and hair before Avogain 2% & 5% application. apply a dose of 1 ml (spray 8 times of Avogain 2% & 5% on the area) spread the solution with massage using fingertips, leave to dry and don't use hair dryer as it may decrease the efficacy of the Avogain 2% & 5%. Continuous twice daily use is required for at least 4 months for best distinguished results.StorageAvogain 2% & 5% solution should be stored below 30ºc. Don't freeze. Keep tightly closed. Protect from light.PackagingAvogain 2% solution is available in 50 ml PE plastic bottle.Avogain 5% solution is available in 50 ml PE plastic bottle.

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AVOHEX MOUTH WASH ®CompositionChlorhexidine gluconate 0.2% w/vIndicationsFor oral hygiene ContraindicationsHistory of hypersensitivity to chlorhexidinePrecautionsAvoid using for children below 6 years old. For external use onlyIn case of contact with eyes or ears wash out promptly and thoroughly with water. Initially change of taste and/or numbness burning or tingling of the tongue may occur but in case of permanent symptoms stop use and consult doctor. Superficial discoloration of the teeth and tongue may occur. For tooth brush, either brush before using and rinse thoroughly, or use at different time of the day. Keep out of reach of children Pregnancy and LactationThere is no evidence of any adverse effects of AVOHEX Mouth Wash on fetus or infants during breast feedingOverdosageConsult doctor for appropriate actionDosage AdministrationNormal routine use: thoroughly rinse the mouth with 10 ml for 1 minute twice daily.StorageStore below 30°C

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AVOMACK SOLUTION ®GeneralDescriptionAvomack solution is a topical solution for the treatment of corns, calluses, hardened skin and warts. (Keratolytic)CompositionSalicylic acid 16.7% w/w and Lactic acid 16.7% w/w.IndicationsAvomack solution is specially designed to treat warts, corns and callusesContraindicationsAvomack solution should not be used for patients who are sensitive to salicylic acid, salicylate or any other components. Do not to be used for children under two years age. Do not apply on birthmarks, hairy warts, warts in the genital area or face. Use under medical supervision in renal insufficiency, pregnancy and after delivery.Side EffectsNo side effects have been reported for topical treatment with Avomack solutionDosage AdministrationSoak the wart, calluses or corn in warm water for 5 minutes, dry the rub the surface carefully with pumice stone or emery board. Put the applicator sheet on the affected area where you can see the affected area within whole. Hold the sheet well. Use the brush to apply Avomack solution on the affected area. Allow to dry and cover with plaster if the affected area is large or on the foot. Continuous daily use is required until the wart, corn or calluses disappeared.StorageAvomack solution should be stored below 25ºc, away from any flame source. Keep tightly closed, protect from lightPackagingAvomack solution is available in 10 ml amber glass bottle with brush and supplied with applicator.

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AVOMEB OINTMENT ®GeneralIS-Sitosterol 0.25% w/w CompositionAvomeb Ointment contains p-Sltosterol in a concentration of 0.25% w/w. Description

Avomeb Ointment is developed to fulfill the theory of moist exposed burn therapy (MEBT). The concept of this therapy is to expose the wound to a physiological moist environment to enhance natural healing process, whereby keratinocytes migration, angiogenesis, and interaction with growth factors are facilitated. PropertiesAvomeb Ointment works by: - Providing an optimum physiological moisture necessary for regeneration and repair. - Inducing an anti-inflammatory effect which helps to reduce edema and erythema. - Developing an unfavorable environment for bacterial and fungal colonization. - Producing an analgesic effect by isolating and protecting the exposed and injured nerve endings. - Isolating and protecting the wound bed from environmental factors while maintaining drainage and gaseous exchange. - Providing local nutrition for wound bed cells.- Liquefying the necrotic tissue. - Reducing body fluids loss from damaged skin (burns). - Absorbing residual heat in acute burn wounds. - Accelerating epithelialization and providing a highly accepted cosmetic appearance. IndicationsAvomeb Ointment is indicated for: - First degree burns, where the pain relief and the fast healing are remarkable, e.g. Sunburn. - Second degree burns, superficial and deep. If properly applied, no need for skin grafting and the regeneration takes place from hair follicles and glands in the dermis and subcutaneous tissue. - Third degree burns, to isolate the wound, reduce pain and expedite nonsurgical debridement of the necrotic tissue to prepare the wound for grafting. - Donor site, to decrease pain, control infection, and expedite healing (in average of 7 days). - Chronic wounds including bed ulcers, diabetic foot, and leg ulcers. - Post laser resurfacing, chemical peeling, and derma abrasion. - Surgical wounds including obstetrical wounds. - Wound of circumcision. - Mucous membrane wounds such as buccal ulcers. - Cracked heels and cracked nipples. Method of Application:1. Burns First degree burns (superficial burns) Avomeb Ointment should be applied as immediately as possible. A thin layer (about 1 mm thickness)Should cover the burnt area and should keep the burn exposed, but if there is a need, a light dressing can be used. Re-application should be done 3 to 4 times daily if exposed or twice daily if closed. Second degree burns - First phase: Liquefying period, apply a thin layer of Avomeb Ointment on the burnt area 3 to 4 times daily. Before reapplication necrotic tissue and the residues of the old Avomeb Ointment should be wiped off gently. It is better to keep the wound exposed, but if there is a need,a light dressing can be applied and renewed twice daily. - Second phase: Repair period, Avomeb Ointment should be applied as before, but less frequently (2-3 times daily). - Third phase: Avomeb Ointment should be applied only once daily. Third degree bums Avomeb Ointment should be applied as mentioned before to liquefy the necrotic tissue. A thin layer should cover the burned site and renewed 3 to 4 times daily. 2. Donor Site A thin layer of Avomeb Ointment should cover the donor site and renewed 3 to 4 times daily if exposed or twice daily if closed. 3. Leg Ulcers A sterile gauze should be impregnated with Avomeb Ointment and should fill the cavity of the ulcer, and renewed twice daily. 4. Surgical and Obstetrical Wounds Avomeb Ointment should cover the wound in a relatively thick layer (about 3mm) under a sterile dressing and renewed twice daily. 5. Cracked Nipples A thin layer of Avomeb Ointment should be applied to the nipple under a light pad, and renewed 3 to 4 times daily. Side EffectsRare allergic reaction to sesame oil. PackagingAvomeb Ointment is available in aluminum tubes of 15g, 30g, 50g and 70g.

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AVOQUIN CREAM ®GeneralHydroquinone 4%CompositionEach gram of Avoquin 4% cream contains 40 mg of Hydroquinone USP, Viatmin C, Vitamin E, Emulgin B2, Cetostearyl Alcohol, Paraffin Oil, Benzoic Acid, Glycerine Propylene Glycol, Sodium Lauryl Sulfate, Citric Acid, Sodium Metabisulfite, Octyl Methoxy Cinnamate and Purified Water.PharmacologyHydroquinone application to skin provides depigmentation by inhibition of enzymatic oxidation of tyrosinase to 3,4 dihydroxyphylalanine.IndicationsAvoquin 4% cream is indicated for the bleaching of melanin hyperpigmentation of the skin such as chloasma, melasma, freckles and other unwanted areas of melanin hyperpigmentation, post-inflammatory hyperpigmentation. Its formula provides gentle and safe way to lighten the skin. ContraindicationsAvoquin 4% cream should not be used for patients who are sensitive to any of its components.Side EffectsNo systemic adverse reactions have been reported. If patient feels any hypersensitivity, discontinue medication and consult your physician. Avoquin 4% cream is used once to twice daily. On application through day time, sunblock should be used. Apply to the affected area and rub gently.StorageStore below 30ºc

PackagingAvoquin 4% cream is supplied in 30g & 50g aluminum tubes.

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AVORAL SHAMPOO ®CompositionEach gram of Avoral Shampoo contains 20 mg of Ketoconazole, Sodium Lauryl Ether Sulphate, PEG 120, Propylene Glycol, Collagen, Coconut Fatty Acid Diethanolamide, Hydrochloric Acid, Disodium Monolaueyl Ether Sulphosuccinate, Imidurea, Sodium Chloride, Sodium Hydroxide, Erythrosin, Ethanol, Perfume and Purified waterPharmacologyKetoconazole, a synthetic imidazole dioxolane derivative, has a potent antimycotic activity against dermatophytes such as Trichophyton sp., Epidermophyton floccosum and Microsporum sp. and against yeast, such as Candida sp. and Malasszia spp. (Pityrosporum spp). PropertiesAvoral Shampoo formula provides you with an effective way for removing dandruff and itching which are usually associated with seborrhoeic dermatitis of the scalp and Pityriasis versicolor. The natural process of scalp-cell renewal is accelerated when fitting off Pityrosporum ovale causing dead cells to fall off faster. This is a leading cause of dandruff and all the symptoms that go with it; the flaking, scaling and itching. The antifungal properties of Ketoconazole related to its ability to impair the synthesis of ergosterol, a component of fungal cell membrane. Maintains your hair's vitality, texture and luster. Avoral Shampoo scent is clean and fresh and it leaves your hair smelling even better. IndicationsAvoral Shampoo is used for treatment and prophylaxis of pityriasis versicolor, seborrhoeic dermatitis and dandruff.ContraindicationsLike all medications, Avoral Shampoo should not be used for persons who have sensitivity to any of its components.Side EffectsRare side effects can be anticipated where the treatment with Ketoconazole is well tolerated. Like all other shampoo products a local burning sensation, itching, contact dermatitis or loss in curl of permanently waved hair may occur. For patient with chemically damaged hair or gray hair a discoloration of the hair may be observed (very rare).Precautions- For external use only- Avoid contact with eyes. If contact occurs rinse the eyes thoroughly with water - No caution for using Avoral Shampoo in pregnancy and lactation cases where it is not absorbed in the skin through topical application.OverdosageNo systematic reactions are associated with Avoral Shampoo since it is intended for external use.Dosage AdministrationThoroughly wet the hair with warm water. Apply a palmful of the shampoo with rubbing with the hair and scalp; let the shampoo be absorbed for five minutes before rinsing with water.Treatment:Pityriasis versicolor: Once daily for 5 daysdandruff and seborrhoeic dermatitis: Twice weekly for 4 weeksProphylaxis:Pityriasis versicolor: Once daily for 3 days before summer.Dandruff and seborrhoeic dermatitis: Once weekly for 2 weeks.StorageStore below 30ºC.PackagingAvoral Shampoo is available in 100ml HDPE plastic bottle.

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AVOTIN-A CREAM ®GeneralTretinoin USP 0.05% w/wCompositionEach 1 g of Avotin-A Cream contains 0.5 mg Tretinoin USP.IndicationsAvotin-A Cream is indicated for the treatment of acne vulgaris.Mode of ActionTretinoin, also known as retinoic acid or vitamin A acid (VAA). Tretinoin, an oxidation product of vitamin A initiates increased cells turnover in both normal follicles and comedones and reduces the cohesion between keratinized cells. It acts specifically on microcomedones (the precursor lesion of all forms of acne), causing fragmentation and expulsion of the microplug, expulsion of comedones, and conversion of closed comedones to open comedones. New comedones formation is prevented by continued use. So as a result of the treatment with AVALON Tretinoin Cream: Open comedones –as a consequence of increased cell proliferation- lifted to the surface usually without any symptoms of inflammation. Closed comedones are either transferred to open ones or changed temporarily into papules or pustules, respectively, that heal without scarring as soon as the keratic plug is cast off. Prevent the formation of new comedones.Application TechniquesThe area of skin to be treated should be washed with water and a mild non-medicated soap, but not more than twice a day. After washing, the skin should be dried gently and completely without rubbing it. Areas of the skin being treated should be allowed to dry completely by waiting for 20-30 minutes before application of Avotin-A Cream. Cosmetics and moisturizers may be used during the treatment with Avotin-A Cream but the areas of the skin to be treated should be washed thoroughly before the application. Astringent cosmetics should be avoided. Avotin-A Cream is applied in a thin layer once daily. Medication is applied to the entire area, not just to individual lesions. An amount of the pea is enough for a full facial application. Patient with a sensitive skin or those living in cold, dry climates may start with an application every other or every third day. The corners of nose, the mouth and the eyes should be avoided; these areas are the most sensitive and the most easily irritated. Tretinoin is applied to the chin less frequently during the initial stages of therapy; the chin is sensitive and is usually the first area to become red and scaly. Sunscreens should be used during the summer months if exposure is anticipated.Response to Treatment

Therapeutic effect may be noticed after two to three weeks of use but more than six weeks of therapy may be required before definite beneficial effects are seen. During the early weeks of treatment, an apparent exacerbation of inflammatory lesions may occur. This is due to the action on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.ContraindicationsHypersensitivity to any component of the product.Side EffectsA short sensation of warmth and /or burning may be noticed following the Avotin-A Cream application. Slight reddening of the skin may occur within the early weeks of treatment. In case of too severe skin irritation the intervals between applications should be prolonged. The most reported undesirable effects were dry skin, burning, stinging, warmth, erythema, pruritis, peeling and temporarily hypo or hyperpigmentation. Rare: blistering and crusting of the skin.PrecautionsAvoid the contact with the eyes, eyelids, angles of the nose and lips to avoid any irritation in these sensitive areas. Medicated soaps and shampoos, waxing preparation and astringent lotions can sometimes irritate even normal skin; so avoid the contact of these preparations with the areas to be treated with Avotin-A Cream. Some patients may suffer from severe irritation on the application of Avotin-A Cream which may induce swelling, burning or stinging, crusting and peeling. In that case the patient should stop the use temporarily or use it less frequently. Patients should avoid procedures which may cause skin irritation such as hair removal at night before applying Avotin-A Cream.For external use only Exposure to Sunlight:Exposure to the sunlight or the ultraviolet sunlamps may provoke additional irritation. So exposure to the sunlight should be avoided or minimized during the treatment with Avotin-A Cream. When exposure to the sunlight cannot be avoided, using of sunscreen is highly recommended.Drug InteractionsConcomitant topical applications, medicated soaps and cleansers, soaps or cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents should be used with caution because of possible interaction with Avotin-A Cream. Particular caution should be considered in using preparations containing sulfur, resorcinol or salicylic acid with Avotin-A Cream. If the patient is using such preparations it is advisable to rest the patient's skin for a time before starting the treatment with Avotin-A Cream.Dosage AdministrationAvotin-A Cream is used once daily to the area of skin where acne lesions occur.StorageStore below 30ºC away from direct light.PackagingAvotin-A Cream is available in 30 g Aluminum tubes. To be dispensed by medical prescription only.

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EZ-CLEAN ®CompositionEthanol 70% v/v, Glycerin, Thickeners, Vitamin-E, Propylene Glycol and Purified Water. PropertiesEZ-CLEAN kills 99.9% of germs within few seconds, with no soap or water needed. lt contains moisturizing agents and is enriched with Vitamin-E to keep skin well-nourished and soft. EZ CLEAN'” can also be used to clean and disinfect surfaces to help prevent the spread of Infections. EZ -CLEAN is a hand disinfectant gel that has a wide ideal spectrum. IndicationsTo help reduce the threat of transfer of germs and bacteria, Avalon has produced the EZ-Clean family of hand-cleaning products. EZ- Clean is easy to use, employs a strong anti-bacterial and anti-fungal agent, and it works on contact. Hospitals everywhere rely on Ez-Clean to fight infection. Convenient EZ-Clean Gel goes on easily, dries quickly and provide immediate cleansing. Plus, Avalon has added soothing, skin-friendly Vitamin-E and an attractive fresh scent.

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EZ-GLIDE ®GeneralCompositionPoIyquatemium, propylene glycol. glycerin. hydroxy ethyl cellulose, methyl paraben, propyl paraben ant purified water.PropertiesWater soluble, ultra slippery, non-sticky, easily washed with water and will not stain.Not flavored or colored to avoid triggering allergy.Safe to use with condoms, diaphragms, douches and enemas.Prolonged lubrication and will not dry out.Designed to mimic the body's natural lubricating fluid.Slightly acidic pH level as in normal healthy vagina to avoid yeast infections.Relieve vaginal dryness and moisturize the vagina.Experience a new level of intimacy.This product is not a contraceptive.IndicationsEz-Glide Personal lubricant is a transparent, water soluble lubricant for- intimate activity.PackagingEz-Glide Is supplied in 75 ml Bottle.Ez-Glide is supplied In 40 ml Tube.

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PRILA 5% CREAM ®GeneralCompositionPRILA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram tubes.Properties

Pharmacokinetic propertiesPRILA Cream is a eutectic mixture of lidocaine 2.5% and prilocaine 2.5% formulated as an oil in water emulsion. In this eutectic mixture, both anesthetics are liquid at room temperature and the penetration and subsequent systemic absorption of both prilocaine and lidocaine are enhanced over that which would be seen if each component in crystalline form was applied separately as a 2.5% topical cream.Absorption: The amount of lidocaine and prilocaine systemically absorbed from PRILA Cream is directly related to both the duration of application and to the area over which it is applied. In two pharmacokinetic studies.Distribution: When each drug is administered intravenously, the steady-state volume of distribution is 1.1 to 2.1 L/kg (mean 1.5, ±0.3 SD, n=13) for lidocaine and is 0.7 to 4.4 L/kg (mean 2.6, ± 1.3 SD, n=13) for prilocaine. The largerdistribution volume for prilocaine produces the lower plasma concentrations of prilocaine observed when equal amounts of prilocaine and lidocaine are administered. At concentrations produced by application of PRILA Cream, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 μg/mL of free base) the plasma protein binding of lidocaine is concentration dependent. Prilocaine is 55% bound to plasma proteins. Both lidocaine and prilocaine cross the placental and blood brain barrier, presumably by passive diffusion.Metabolism: It is not known if lidocaine or prilocaine aremetabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine. The metabolite, 2,6-xylidine, has unknown pharmacologic activity. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively. Prilocaine is metabolized in both the liver and kidneys by amidases to various metabolites including ortho-toluidine and N-n-propylalanine. It is not metabolized by plasma esterases. The ortho-toluidine metabolite has been shown to be carcinogenic in several animal models.Elimination:- The half-life of lidocaine elimination from the plasma following IV administration is approximately 65 to 150 minutes (mean 110, ±24 SD, n=13). More than 98% of an absorbed dose of lidocaine can be recovered in the urine as metabolites or parent drug. The systemic clearance is 10 to 20 mL/min/kg (mean 13, ±3 SD, n=13). The elimination half-life of prilocaine is approximately 10 to 150 minutes (mean 70, ±48 SD, n=13). The systemic clearance is 18 to 64 mL/min/kg (mean 38, ±15 SD, n=13). During intravenous studies, the elimination half-life of lidocaine was statistically significantly longer in elderly patients (2.5 hours) than in younger patients (1.5 hours). No studies are available on the intravenous pharmacokinetics of prilocaine in elderly patients.Pediatrics: Some pharmacokinetic (PK) data are available in infants (1 month to <2 years old) and children (2 to <12 years old). One PK study was conducted in 9 full-term neonates (mean age: 7 days and mean gestational age: 38.8 weeks). The study results show that neonates had comparable plasma lidocaine and prilocaine concentrations and blood methemoglobin concentrations as those found in previous pediatric PK studies and clinical trials. There was a tendency towards an increase in methemoglobin formation. However, due to assay limitations and very little amount of blood that could be collected from neonates, large variations in the above reported concentrations were found.Special Populations: No specific PK studies were conducted. The half-life may be increased in cardiac or hepatic dysfunction. Prilocaine's half-life also may be increased in hepatic or renal dysfunction since both of these organs are involved in prilocaine metabolism.IndicationsPRILA Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:- normal intact skin for local analgesia.- genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. PRILA Cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studiesContraindicationsPRILA Cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivityto local anesthetics of the amide type or to any other component of the product.Side EffectsLocalized Reactions: During or immediately after treatment with PRILA Cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of PRILA Cream have been reported. The relationship to PRILA Cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 PRILA Cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions which were ascribed to PRILA Cream.Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of PRILA Cream.In patients treated with PRILA Cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%. In clinical studies on genital mucous membranes involving 378 PRILA Cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).Allergic Reactions: Allergic and anaphylactoid reactions associated with lidocaine or prilocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.PrecautionsApplication of PRILA Cream to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious adverse effects.Studies in laboratory animals (guinea pigs) have shown that PRILA Cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to PRILA Cream in the external auditory canal only, showed no abnormality. PRILA Cream should not be used in any clinical situation in which its penetration or migration beyond the tympanic membrane into the middle ear is possible.General:Repeated doses of PRILA Cream may increase blood levels of lidocaine and prilocaine. PRILA Cream should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated, or elderly patients. PRILA Cream coming in contact with the eye should be avoided because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of PRILA Cream in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however PRILA Cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine. Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth. The effect of PRILA Cream on intradermal injections of live vaccines has not been determined.Drug Interactions: PRILA Cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition.Pregnancy and Lactation

Category B.Labor and Delivery: Neither lidocaine nor prilocaine are contraindicated in labor and delivery. PRILA Cream when used concomitantly with other products containing lidocaine and/or prilocaine, total doses contributed by all formulations must be considered.Nursing Mothers: Lidocaine, and probably prilocaine, are excreted in human milk. Therefore, caution should be exercised when PRILA Cream is administered to a nursing mother since the milk: plasma ratio of lidocaine is 0.4 and is not determined for prilocaine.Pediatric Use: Controlled studies of PRILA Cream in children under the age of seven years have shown less overall benefit than in older children or adults. These results illustrate the importance of emotional and psychological support of younger children undergoing medical or surgical procedures. PRILA Cream should be used with care in patients with conditions or therapy associated with methemoglobinemia When using PRILA Cream in young children, especially infants under the age of 3 months, care must be taken to insure that the caregiver understands the need to limit the dose and area of application, and to prevent accidental ingestionDosage AdministrationAdult Patients – Intact SkinA thick layer of PRILA Cream is applied to intact skin and covered with an occlusive dressing.Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of PRILA Cream (1/2 the 5 g tube) over 20 to 25 cm² of skin surface for at least 1 hour. In controlled clinical trials using PRILA Cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of PRILA Cream per 10 cm² of skin and allow to remain in contact with the skin for at least 2 hours.Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of PRILA Cream (1 g/10 cm²) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of PRILA Cream.Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream.Adult Female Patients – Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5- 10 grams) of PRILA Cream for 5 to 10 minutes. Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the PRILA Cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of PRILA Cream.Pediatric Patients – Intact SkinThe following are the maximum recommended doses, application areas and application times for PRILA Cream based on a child's age and weight:Application Time0 up to 3 months or < 5 kg 1 g 10 cm² 1 hour3 up to 12 months and > 5 kg 2 g 20 cm² 4 hours 1 to 6 years and > 10 kg 10 g 100 cm² 4 hours7 to 12 years and > 20 kg 20 g 200 cm² 4 hoursPRILA Cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents.StorageStore at controlled room temperature 15–30°C (59–86°F). Do not freezePackagingPRILA Cream is available as the following:5 gram tube*5, box contains 5 transparent dressings.

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SALINOSE ®GeneralNasal Sodium Chloride SolutionCompositionEach 1 ml of Salinose contains Sodium Chloride 9mgIndicationsSalinose provides soothing relief from clogged nasal passage without stinging or burning. It also provides immediate relief for dry, inflamed nasal membranes due to colds, low humidity, minor nose bleeding, over use of topical nasal decongestants and other nasal irritants. Side EffectsIn general, Salinose has no associated side effects.Dosage AdministrationFor infants 2 to 6 drops in each nostril as needed or as directed by the physician. For children (6 years) and adults 1 to 3 sprays in each nostril 1-3 times daily or as directed by the physician.StorageStore below 30ºc, and protect from direct line.Packaging20 ml plastic dropper bottles (Salinose baby)30 ml plastic sprayer bottles (Salinose Adult)

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SALINOSE NASAL GEL ®CompositionSodium Chloride 1% w/wProperties and IndicationsSalinose nasal gel moistens the dry or inflamed nose mucous membranes due to cold, low humidity, minor nose bleeding, overuse of topical nasal decongestant and other nasal irritants.Restore nasal membranes function especially after chronic use of nasal corticosteroidsSide EffectsIn general, Salinose nasal gel is generally well tolerated and non-irritant.Dosage AdministrationApply Salinose nasal gel in each nostril with gentle massage. Once or twice daily or as directed by the physician.StorageStore below 30ºc, and protect from direct line.PackagingSalinose nasal gel is available in 30 g aluminum tube. Supplied with nozzle applicator for easy use.

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SALINOSE PLUS NASAL SPRAY ®CompositionEach 1ml of Salinose plus nasal spray contains:3.3 mg of sodium chloride8.3 mg of sodium bicarbonateIndicationsProvides soothing moisture to dry, inflamed nasal membranes in cases of:Colds, Allergies. Low humidity and other nasal irritants.Enhance mucus clearance in conditions of:Rhinitis, acute and chronic rhinosinusitis, allergic, non-allergic and atrophic rhinitis.ContraindicationsThere is no experience of contraindications against Salinose nasal spray. However after nose operations or accidents a doctor should be consulted before using Salinose nasal spray.Side EffectsIf used correctly, side effects are not to be expectedPrecautionsDue to reasons of hygiene and to avoid infections, every bottle of Salinose nasal spray should only be used by one person.For pregnant and nursing mothers, consult your physician before using Salinose nasal spray.Dosage AdministrationAdult and children (from two years onwards): spray 1-2 puffs into each nostril several times daily.Infants and children (up to age of 2 years): Spray 1 puff into each nostril several times daily.AdministrationInsert the spray nozzle into the nostril and apply pump mechanism. In doing so keep the bottle vertical and don‘t bend head backwards. During the spraying process breathe normally through the nose.StorageStore at temperature below than 30ºc, away from direct sunlight.PackagingSalinose nasal spray is available in 20 ml PE spray bottle.

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VAGINAL DOUCHE PLUS ®GeneralContains 10% w/v Povidone Iodine U.S.P. PropertiesAvalon Vaginal Douche has the broad antimicrobial spectrum of Iodine, but has no undesirable features and disadvantages associated with elemental Iodine. It kills gram positive and gram negative bacteria, fungi, protozoa, spores and viruses. It is active against antibiotic-resistant microorganism. No resistance to Avalon Vaginal Douche microbicidal effect has been observed. It has an immediate onset and prolonged duration of action. Its activity is not affected by blood, pus, soap or bile. Avalon Vaginal Douche is a vaginal cleanser with a broad spectrum of activity. it rapidly eliminates all vaginal pathogens, drastically reduces the risk of infection and prevents recurrence of symptoms. It is non-irritant to the vaginal mucosa. IndicationsFor non-specific vaginitis, mixed vaginal infection, candidal vaginitis, trichomonal vaginitis or preoperative preparation of the vagina. Characteristics of “Avalon Applicator” 1- Easily held in one hand 2- Design allows for effective spurting inside vagina. 3- It can be easily cleaned. PrecautionsDiscontinue use in rare cases of sensitivity. Should not be used in case of known Iodine sensitivity. Only use under medical supervision in pregnancy and after delivery. Dosage AdministrationFor the treatment of vaginitis: Once a day for 14 days, throughout the menstrual cycle preferably before bedtime. If further therapy is required, douching should be continued through the next two cycles. It may be-recommendable for the patient to return for an office visit following two weeks of therapy. For routine vaginal douching: Once or twice a week. Important Notes for the patient 1- Please use warm water (tap water) when preparing the solution, as cold water will contract vaginal membrane resulting in improper douching. 2- Wash the applicator after use with clean water and wipe it dry. 3- Don't lend your applicator to others. NOT TO BE USED BY VIRGINS