united states environmental protection agency …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14...

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10 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL, SAFETY AND POLLUTION PREVENTION Elisa Estremera, The Clorox Company, c/o PS&RC; P.O. Box 493, Pleasant, CA 94566-0803 OCT -1 2014 Subject: EPA Registration: Application Date: Receipt Date: Submission #: Dear Elisa Estremera, Clorox QW 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable. Proposed Amendment: Revisions to the master label. General Comments A stamped copy of the labeling accepted with conditions is enclosed. Submit three (3) copies of your final printed labeling before distributing or selling the product bearing the revised labeling. Should you have any questions or comments concerning this letter, please contact Velma Noble PM Team 31 at (703) 308-6233 or Jamil Mixon at (703) 308-8032. Sincerely, Velma Noble, Product Manager, Team 31 Regulatory Management Branch Antimicrobials Division (751 OP) Enclosure

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Page 1: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

10

UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460

OFFICE OF CHEMICAL, SAFETYAND POLLUTION PREVENTION

Elisa Estremera,The Clorox Company,c/o PS&RC; P.O. Box 493,Pleasant, CA 94566-0803

OCT -1 2014

Subject:EPA Registration:Application Date:Receipt Date:Submission #:

Dear Elisa Estremera,

Clorox QW11346-47/2/147/7/14954579

The following amendment(s), submitted in connection with registration under Federal Insecticide,Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable.

Proposed Amendment:

• Revisions to the master label.

General Comments

A stamped copy of the labeling accepted with conditions is enclosed. Submit three (3) copies ofyour final printed labeling before distributing or selling the product bearing the revised labeling.

Should you have any questions or comments concerning this letter, please contact Velma NoblePM Team 31 at (703) 308-6233 or Jamil Mixon at (703) 308-8032.

Sincerely,

Velma Noble,Product Manager, Team 31Regulatory Management BranchAntimicrobials Division (751 OP)

Enclosure

Page 2: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bolt, italicized tertand (italicized text within parentheses) \$' nation for the reader and is not part of the label. [Bracketed]information and phrase sequence are optional unless specifil^ i CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 4(i-u, n. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (tex*) means removed.RC034021

EPA Reg. No. 11346-4 Clorox®QS Page1ot17

Clorox QSKEEP OUT OF REACH OF CHILDREN

CAUTION:SEE [SIDE] [BACK] LABEL -OR- PAMEL FOR ADDITIONALPRECAUTIONARY STATEMENTS.

ACTIVE INGREDIENTS:n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18)dimethyl benzyl ammonium chlorides 0.105%n-Alkyl (68% C12, 32% C14) dimethylethylbenzyl ammonium chlorides 0.105%OTHER INGREDIENTS: 99.790%TOTAL: 100.000%

[NET] [CONTENTS]

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I I OCT.1 2014 I

RC034021 .indd 1 7/2/14 7:59 AM

Page 3: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bolt, italicized text and (italicized text within parentheses) \si^ ''ation for the reader and is not part of the label. [Bracketed]information and phrase sequence are optional unless specifies^ CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 40 tf n. Listed uses and use sites can be used partially or in ttieirentirety. Highlighted text is new. Strike-through (tat) means removed.RC034021

EPA Reg. No. 11346-4 CloroxOQS Page2of17

PRECAUTIONARY STATEMENTS: HAZARDS TO HUMANS AND DOMESTIC ANIMALSCAUTION: Causes moderate eye irritation. Avoid contact with eyes, skin or clothing. Wash thoroughly with soap and water after handling andbefore eating, drinking, chewing gum, using tobacco, or using the toilet. Avoid contact with foods.

FIRST AID:IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first 5minutes, then continue rinsing eye. IF ON SKIN OR CLOTHING: Take off contaminated clothing. Rinse skin immediately with plenty of waterfor 15-20 minutes. Call a poison control center or doctor for treatment advice. Have the product container or label with you when calling apoison control center or doctor, or going for treatment. [Emergency Information: 1-800-446-1014.-or-Poison Control Center: (800)446-1014-or- Clorox Information Line: 1-888-797-7225 -or- Questions? Call 1-888-797-7225.]

For containers 1 gallon or less:Nonref/liable bottlesSTORAGE AND DISPOSAL:Store only in a tightly closed container in a secure area inaccessible to children. Nonrefillable container. Do not reuse or refill empty container.Recycle empty container or discard in trash.

Refutable bottles intended to be refilled by the consumerSTORAGE AND DISPOSAL: Do not reuse or refill this container except as described in the directions for use. Refill only with this product.Recycle empty container or discard in trash.

Questions or Comments? Call (800) 492-9729 or visit us at www.clgroxcareconcepts.com.A list of this product's ingredients is available at www.lngredientslnside.com.-or- For more product ingredient information visit www.lngredientslnside.com.Contains no phosphorusMfd. for The Clorox Company.Packed for The Clorox Company, 1221 Broadway, Oakland, CA 94612.Clorox is a registered trademark of The Clorox Company.CareConcepts is a registered trademark of The Clorox Company.©2013 Made in the U.S.A.EPA Reg. No. 11346-4EPA Est. NO. 5813-CA-3 (A8 or H8); GA-1 (A4), 6A-2 (VG), IL-2 (VF); 8251-OH-1 (Q6), WI-3 (KV),

WI-5 (UQ); 58455-IN-1 (C6), IIM-2 (01); 71681-GA-1 (JG), IN-1 (GU), ll\l-2 (24); 71106-GA-2 (E8)

Beginning of batch code indicates Est. No.

2 MIN. CONTACT TIME:E.faeciumS.aureusK.pneumoniaeA.baumanniiP.aeruginosaE .aerogenes

Optional graphics/text. May be placed anywhere on label/container or collateral labeling.

C O N C E P T S

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PAPER

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Empty*Discard Sprayer

[[Use your phone to] go here -and/or- scan [[the] tag-or- [this] code] to learn -or- get -or- see [more] uses -or-information [on how-to-use [This Product]] -or- [how-to]tips -or- [how-to [-use]] videos] [(Data rates may apply)]

PLASTICBOTTLE

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I

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Page 4: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bold, italicized text and (italicized text within parentheses) is" -nation for the reader and is not part of the label. [Bracketed] /' EPAReg. No. 11346-4 CloroxOQS Page3o(17information and phrase sequence are optional unless specifii, ) CFR 156.10. Variables such as CAPITALIZATION, plurals \or singular, bold and italics are optional unless specified in 40 u,ri. Listed uses and use sites can be used partially or in their '•* 'entirety. Highlighted text is new. Strike-through (text) means removed.RC034021

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (I. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

Packaging Related StatementsTo Operate:Open hinged cover of sprayer and snap into opening on top. -or- Turn -or- Rotate nozzle [counterclockwise] to "spray" -or- "stream" -or-ON [setting], -or- Adjust [nozzle] to desired pattern.

-or-

To open, turn nozzle. Spray 6-8 inches from surface. Rub -or- wipe with brush -or- paper towel -or- sponge -or- lint-free cloth -or- cloth. Donot breathe spray or mist. . •

[When almost empty, -or- To spray every drop[,][:] tilt bottle downward -or- at a downward angle [while spraying].]

-or-

Operating TriggerTo Operate:Open hinged cover of sprayer and snap into opening on top. -or- Turn nozzle [counterclockwise] to "spray" -or-"stream" [setting], -or- Adjust [nozzle] to desired pattern.

-or- •

To open, turn nozzle. Spray 6-8 inches from surface. Rub -or- wipe with brush -or- paper towel -or- sponge -or- lint-free cloth -or- cloth.

Trigger options:Switch to open-or-on-or- 'To refill: Twist trigger [on spray bottle] [1/4 turn] [counterclockwise] [and pull up -or- upward[s]] to remove. [Fill spraybottle with refill solution.] [After refilling spray bottle,] [to replace trigger,] Align [red tip] tube on trigger [head] over[small] opening -or-tube [on] [the] inside [of the bottle]. [[Note that] trigger [head] should point in [the] same directionas [the] tube [running] on the outer edge of the bottle.] Press [straight] down on the trigger [head], [applying evenpressure] [until it clicks -and/or- locks] [into place].

Packaging Related Claims:[Now] [New][!] -and/&/or- [Improved] to be used as a claims descriptor only for the first 6 months of product on shelf

1 Align to close•[Be] [Get] RefillSmart[™][!]• Get -or- Spray Every Drop[!][™]1 Last Drop Access1 No Waste -or- Wasteless Bottle

1 Patented design bottle1 Recyclable bottle• Smart Tube[®][™] Technology1 [Use as a] [Pourable] refill for this product

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Page 5: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Hole: Bold, italicized text and (italicized text within parentheses) is^ 'nation for the reader and is not.part of the label. [Bracketed]information and phrase sequence are optional unless specilieY /' CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 40'1'rH. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (text) means removed.RC034021

EPA Reg. No. 113464 Clorox®QS Page4of175

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

DIRECTIONS FOR USEIT IS A VIOLATION OF FEDERAL LAW TO USE THIS PRODUCT IN A MANNER INCONSISTENT WITH ITS LABELING.

For surfaces that may come in contact with food, a potable water rinse is required.

Do not use on soft vinyl, varnishes, or aluminum. If applied to those surfaces, rinse and wipe dry immediately. For painted surfaces, testsmall area first, -or- For best results, always test a small area before washing -or- applying.

Cleaning and General Use

DIRECTIONS FOR USE:General [Kitchen/Bathroom/Floor] Cleaning: [Remove cooking ingredients and cooked food from areas to be cleaned.] [To Use FullStrength:] Spray product directly onto soils and wipe clean, -or- Directly apply [this product] with a cloth, sponge, mop, or trigger sprayer tocompletely wet surface and wipe clean. No rinsing needed. Repeat for heavily soiled areas. [To Use Diluted:] [To clean large hard surfacesand floors:] Mix 8 oz -or-1 cup [of this product] with 1 gallon water. Wet surface completely with cloth, sponge, or mop.

To Clean/Remove Soap Scum: Spray product onto soils and wipe clean [with a dry paper towel or lint-free cloth or sponge], -or- Just sprayon and wipe off [with a dry paper towel or lint-free cloth or sponge]. No scrubbing or rinsing necessary. For best results, use a dry paper towelor lint-free cloth. Repeat for heavily soiled areas. For stubborn stains or heavily soiled areas or tougher jobs, allow product to penetrate [dirt-and/or- soap scum] before wiping. For best results, use regularly to prevent dirt and soap scum build up.

To Clean [Nonporous] Surfaces -and/or- Floors: Spray soiled area, then wipe clean, -or- For spot cleaning, spray and wipe clean with dampsponge -or- mop. [For larger areas, [remove trigger sprayer and] mix one cup of this product per gallon of warm water and apply with a sponge-or- mop.]

To Clean Toilets: To clean and deodorize toilet bowl, squirt liberally (1/2 cup) on toilet sides and upper toilet bowl rim. Swab -or- brush allsurfaces and flush.

RC034021.indd 4 7/2/14 7:59 AM

Page 6: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bali, ttalic'aei text and (italicized text within parentheses) iy"~'-Tiation for the reader and is not part of the label. [Bracketed] f EPA Reg. No. 11346-4 Clorox® QS Page 5 of 17information and phrase sequence are optional unless specific, ICFR 156.10. Variables such as CAPITALIZATION, plurals (or singular, bold and ita/i'cs are optional unless specified in 4(i\.,-rf. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (tot) means removed.RC034021.

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

DIRECTIONS FOR USE Continued:DISINFECTION

To [Clean and] Disinfect [hard, nonporous surfaces]: [Set trigger to SPRAY.] Spray 6-8 inches from surface until surface is thoroughly wet.Let stand for contact time listed below -or- on label. Wipe excess. [Rinse.] Allow to air dry. Rinse with potable water for food-contact surfaces.For all others, no rinsing is required. Gross filth should be removed prior to disinfecting. [If streaking is observed, wipe with a clean, damp[cloth or] paper towel.]

MOLD AND MILDEW: To control mold and mildew: Apply to precleaned hard, nonporous inanimate surfaces. Allow to air dry. Repeatapplication weekly or when growth reappears.

(to tie used in an educational insert for "Home Healthcare kits")Use [the] (insert ABN) -or- this product to spray surfaces to be disinfected -or- treated. Refer to [the] [product] label for directions for useand precautionary statements.-or-Use [the] (insert ABN) -or- this product to spray surfaces to be disinfected -or- treated. To Disinfect: Hold container 6-8 inches from thesurface to be treated and spray area until it is covered with the solution. Allow this product to penetrate and remain wet. Let stand for contacttime listed below -or- on label (input contact times/organisms from organism table). Then wipe. For heavily soiled areas, a precleaning isrequired. For food contact surfaces such as counter, tables and appliance exteriors, rinse disinfected surface with potable water. Do not useon glasses, dishes, or utensils.

NOTE TO REVIEWER: This statement to be used on home healthcare labels with medical devices and/or bloodborne pathogens:This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into thehuman body, either into or in contact with the bloodstream, or normally sterile areas of the body, or (2) contacts intact mucous membranes,but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used topreclean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection.For products with medical devices listed on the label, the following must be used:This product is not for use on critical or semi-critical medical device surfaces.

Special Instructions for Use Against HIV-1, HBV, and HCVThis product kills HIV-1, HBV and HCV on precleaned hard, nonporous surfaces/objects previously soiled with blood/body fluids in health caresettings or other settings in which there is an expected likelihood of soiling of surfaces/objects with blood or body fluids, and in which thesurfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission of Human ImmunodeficiencyVirus (HIV-1) (associated with AIDS), Human Hepatitis B [(Virus)] (HBV) and HumanHepatitis C [(Virus)J(HCV).

Special instructions for using this product to clean and decontaminate against HIV-1, HBV and HCV on surfaces/objects soiled with blood/body fluids: Personal Protection: When handling items soiled with blood or body fluids, use disposable impervious gloves, gowns,masks and eye coverings. Cleaning Procedure: Blood and other body fluids must be thoroughly cleaned from surfaces and other objectsbefore applying this product. Contact Time: Allow surface to remain wet for HBV, HCV and HIV-1 for 1 min[ute]. These contact times will notcontrol other common types of viruses and bacteria. Disposal of Infectious Materials: Use disposable impervious gloves, gowns, masks andeye coverings. Blood and other body fluids must be autoclaved and disposed of according to local regulations for infectious waste disposal.

This product [-or- product name] is a one step germicidal [disinfectant] cleaner and deodorant [odor counteractant] [odor neutralizer]Designed for general cleaning, [and] disinfecting [deodorizing] [of] hard, nonporous inanimate surfaces. Quickly removes dirt, grime, mold,mildew, food residue and other organic matter. It [also] eliminates odors leaving [restroom] surfaces smelling clean and fresh. Use whereodors are a problem.

[This product] is a ready to use [broad spectrum] [germicidal] [disinfectant] cleaner and deodorizer designed for general cleaning [and]disinfecting [deodorizing] [of] hard, nonporus surfaces. Quickly removes dirt, grime, mold, mildew, food residue and other organic matter.

RC034021.irdd 5 7/2/14 7:59 AM

Page 7: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

EPA Reg. No. 1 1 346-4 Clorox® QS Page 6 of 1 7Note: Bold, italicized ten and (italicized text within parentheses) if'"" ration for the reader and is not part of the label. [Bracketed] /information and phrase sequence are optional unless specific J CFR 156.10. Variables such as CAPITALIZATION, plurals Ior singular, bold and italics are optional unless specified in 40surrt. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (ted) means removed. • .RC034021

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit. "

Cleaning and General Use Claims:Now-and/or- New [!] and -or- & Improved [!] io be used as a claim descriptor only for the first 6 months of product on shelf.

Non-disinfectancy-related bullets/bursts/sentences:• Advanced cleaning formula• An effective, [non-food contact surface] cleaner for use in the

kitchen, bathroom, bedroom, and other areas• Be ready• Bleach-free when used with Clorox® alternate brand name• Care -or- caregiving concepts•Clean Home• Clean[-up] -or- manage -or- handle bodily -or- biological fluids

-or- vomit -and/or- urine -and/or- feces.• Clean up with the one thing that can handle the kitchen• [Cleaner] [Quick] [Easy] [Effective] [Fast Effective] [Convenient]• Cleaning [made easy]• Cleans and Deodorizes in One Easy Step• Cleans everyday kitchen -and/or- bathroom messes• Cleans [everyday messes] [grease and grime] throughout the

house• Cleans [Fast,] [All Over the House] [in Kitchens and Bathrooms]• Cleaner• Cleans grease• Cleans hard, nonporous surfaces• Cleans kitchen -and/or- bathroom surfaces• Cleans quick[ly]• Cleans soap scum -or- dirt -or- build-up•Cleans [surfaces] [throughoutthe house]•Cleans the toughest soils• Cleans tough [grease] [kitchen] [bathroom] messes [without

smearing] [fast]• Cleans tough messes• Clorox® clean• Colored surfaces• Contains no abrasives, harsh acids• Contains no bleach [when used with Clorox® alternate

brand name]• Cuts cleaning time• Cuts -or- Cleans greasy dirt -and/or- soap scum -and/or- bathroom

soils [fast]• Deep cleaning] [cleaner -or- formula]• [Delivers] a clean you can see and smell• Deodorizes• Designed for Home Healthcare -and/or- patients -and/or-

caregivers• Designed for use on multiple surfaces• Does not contain bleach [when used with Clorox® alternate brand

name]• Dries quickly

• [Easily cleans the] -and/or- Toughest [on] grease [and grime][throughout the house]

1 Designed -or- developed for Home Caregivers• Designed -or- developed for use in Home Healthcare -or- Home Care•Easyto handle• Easy [and convenient] to use• Effectively removes [everyday] soils [on: Table A]• Eliminates -or- Removes [kitchen] [bathroom] odors• Fights -and/or- helps eliminate -and/or- controls odors at the source• Fights -and/or- helps eliminate -and/or- controls odors on [hard-to-treat] [areas like] (insert use site/surface) -and/or- hard, nonporoussurfaces

1 For a cleaner, fresher household• [For] general use• [For] Home [Care]1 For [home] healthcare use1 For Home Use• For more advice -or- tips -or- education -or- support -or-

information) call us [toll free] at (insert phone number)• For more advice -or- tips -or- education -or- support -or-

information) visit us at our Facebook page atwww.(insert website).com

• For more advice -or- tips -or- education -or- support -or-information) visit us at www.(//;serf website).com

• [For] Surface [care]• [For] Surface cleaning• For Use by Home Caregivers• For Use in Home Healthcare1 For use on bathroom surfaces1 For use on hard, nonporous surfaces only1 Freshensp Good for everyday cleaning -and/or- for your toughest messes1 Great for use around the home• Great in the Kitchen and Bathroom> (Insert product Brand) is a new (To be used as a claim descriptoronly for the first 6 months on shelf) line of home caregiving productand practical resources. Kits are available for the most commoncaregiving needs [as well as refill -and/or- replenishment items.]

•Just spray and wipe• Leaves area smelling clean with a light [fresh] [citrus] [lemon]

[mist] [orange] scent'• Making home health care [more] manageable -or- easier -or-

simpler• Maximum Cleaning, Minimum Effort• Multi-Purpose [Cleaner]• Multi-surface

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Page 8: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bald, Italicized text and (italicized text within parentheses) if nation (or the reader and is not part of the label. [Bracketed] i EPA Reg, No. 11346-4 CloroxOQS Page 7 of 17information and phrase sequence are optional unless specifiev j CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 40 l/l-R. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (text) means removed.RC034021

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanilizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

Cleaning and General Use Claims Continued:Now-and/or- New [!] and -or- & Improved [!] \o be used as a claim descriptor only for the first 6 months of product on shelf.

1 Neutralizes odors [(doesn't [just] mask)]1 Mo harsh chemical odors or fumes• No [Unpleasant] Fumes1 Non-abrasive formula [will not scratch surfaces]1 Non-bleach [when used with Clorox® alternate brand name]• Passes the kitchen everyday use -or- torture test1 Perfect -or- Ideal for [greasy] [tough] [grimy] messes [around -qr-in the [kitchen] [bathroom] [bedroom]]

• Products and [practical] advice -or- tips for cleaning after messescaused by -or- like bodily fluids -or- urine [,] -and/or- vomitf,]-and/or- feces.

1 Produces] -and/or- support for Cleaning[-up] -or- managing -or-handling bodily -or- biological fluids -or- vomit -and/or- urine-and/or- feces.

1 Removes [tough] stains

• Removes urine -and/or- feces -and/or- vomit stains on hard surfaces• Shelf-stable formula• Starts cleaning [-or- to work] on contact [-or- instantly]• [The] One Step Cleaner• [The] smell of clean•This product is a multi-surface cleaner[, for use on [insertsurfaces

from Table A]]• [This product] is for non-scratch cleaning of [insertsurtace(s) from

Table A]• This product's formula cleans• Usable on a variety of soils.• Versatile• Won't leave a room smelling of strong chemicals• You can be sure your -or- the surfaces are clean

Cleaning And Stain Removal Claims:

To clean -and/or- remove stains: Spray surface; [rinse and] let air dry. [If streaking is observed, wipe with a clean, damp [cloth or] paper towel.

Now -and/or- New [!] and -or- & Improved [!] to be used as a claim descriptor only for the first 6 months of product on shelf.

Claims:• Removes -and/or- Cleans the following insert stain.-or-• Works on -or- effective against -or- removes insert stain

Stains/Soils:[Automotive] [Splattered] GreaseBathtub RingBeverage StainsBodily FluidsBody oils[Common] soilsCosmeticsCrayon and Pencil [Marks]Dead skinDefecation

DirtFecal matterFecesFingerprintsFood -or- Greasy -or- Oily Spills

-or- Splatters -or- Messes[Food] stainsGrimeHeel Marks -or- scuffsJuice Stains

MucusMudOutdoor GrimePen -or- Ink [Marks]Pet StainsPhlegmProtein-based matterSalivaSmudgesSoap Scum

Spitftle]SputumSticky Food Messes -or- SpillsStoolThrow-UpTough SoilsUrineVomitWine Stains

Fragrance/Scent Descriptors and Claims:

1 Fragrance Free • Unscented

Page 9: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Hole: Bold, italicized text and (italicized text within parentheses) if lation for the reader and is not part of the label. [Bracketed]information and phrase sequence are optional unless specified ,. J CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 40 CFR. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (text) means removed.RC034021

EPA Reg. No. 11346-4 Clorox® OS Page 8 of 17

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (I. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

Now -and/or- New [!] and -or- & ImprovedDisinfection/Pesticidal Claims:

] to be used as a claim descriptor only for the first 6 months of product on shelf.

• A combination disinfectant [sanitizer -and/or- deodorizer,] andmulti-purpose cleaner

• An effective disinfectant for use in the kitchen, bathroom,bedroom, and other areas

• Antibacterial [Formula]• Antibacterial Formula Cleans and Disinfects•Antibacterial -or- Germicidal Cleaner [on hard, nonporoussurfaces] [for Kitchens and Bathrooms]

• Antibacterial -or- Germicidal [Formula]• Broad Spectrum Disinfectant• Can help reduce the spread of germs on surfaces• Clean and disinfect in one easy step• Cleaner, degreaser, disinfectant• Cleaner and disinfectant in one• [Cleans and] Disinfects•Cleans, Disinfects & Deodorizes• Cleans, Disinfects and Deodorizes in one easy step• Demonstrated Effectiveness against (insert organims from list) [on

hard, nonporous surfaces -or- on (insert use site from Table A)]• Designed -or- developed to clean -and/or- disinfect -and/or- and

deodorize surfaces after human messes -or- [liquid-and/or- solid]waste

• Designed -or- Developed to manage -or-handle -or- clean-up-and/or- disinfect after difficult -or- challenging -and/or- biological-or- bodily -or- messes -or- liquid -and/or- solid waste.

• Disinfect hard, nonporous surfaces after messes caused by-or- like bodily -or- biological fluids -or- vomit -and/or- urine-and/or- feces.

• Disinfectant• Disinfectant Cleaner• Disinfects [Germs]• Disinfects [washable] kitchen surfaces including killing [99.9% of]

germs -and/or- bacteria -and/or- viruses:): -and/or- fungi• Easily clean and disinfect• [For] Disinfecting• [For] Germ Kill• For handling tough messes -or- [liquid -and/or- solid] waste

consider (insert Kit Name), to clean, disinfect, and deodorizesurfaces after human messes -or- [liquid -and/or- solid] waste

• For preventing the spread of germs consider Clorox®CareConcepts™ (Insert Kit Name), products and practical advicefor preventing the spread of common home care germs.

• Fungicidal -or- Antifungal• Hard surface disinfectant• (Insert product Brand, e.g. Clorox®) is a new (To be used asa claim descriptor only for the first 6 months on shelf) line ofproducts and practical advice [that includes help with killing germs][that may be brought home from the hospital or outside]. Thedisinfecting products included [are designed to] kill germs [andprevent the spread of germs] [on hard, nonporous surfaces].

• (Insert Kit Name) provides a means to manage, deodorize, anddisinfect areas where biological messes -or- [liquid -and/or- solid]waste may occur.

• Kills [99.9% of] Bacteria• Kills [99.9% of] Germs• Kills [99.9% of] [kitchen] [bathroom] bacteria [in minutes]• Kills bacteria -or- germs -or- viruses:): on washable kitchen

-and/or- bathroom surfaces and fixtures• Kills bacteria -or- germs -or- viruses:): [while it cleans] [tough]

[everyday] [kitchen] [bathroom] [messes]• Kills bacteria -or- viruses}• Kills Flu Virusf [Influenza A virus]• Kills [household] bacteria [without bleaching]• Kiljs Influenza A virus [, the virus that causes the common flu]• Kills -or- Fights -or- is effective against (insert organims from list)

[on hard, nonporous surfaces-or-on (insert use site from Table A)]• Kills [Salmonella enterica] [kitchen germs]• Products and [practical] advice -or- tips for cleaning -and/or-

disinfecting surfaces after messes caused by -or- like bodily fluids• Product[s]'-and/or- support for handling -or- cleaning-up

-and/or- disinfecting after difficult -or- challenging -and/or-biological -or- bodily -or- messes -or- liquid -and/or- solid waste.

• Produces] -and/or- support for disinfecting hard, nonporoussurfaces after messes caused by -or- like bodily -or- biologicalfluids -or- vomit -and/or- urine -and/or- feces.

• Products [and solutions] for controlling -or- neutralizing [common][home healthcare] odors [around the house -and/or- at the source-and/or- in home healthcare]

1 Products [and solutions] that fight -or- help eliminate [common][home healthcare] odors [around the house -and/or- at the source-and/or- in home healthcare]

• Ready to use cleaner and disinfectant• Ready to use disinfectant cleaner• Ready to use formula provides cleaning, disinfecting and

deodorizing in one step• Suite -or- Collection -or- Set -or- Selection -or- Assortment of

products that [work] together [to] help eliminate -and/or- fight-and/or- control -and/or- neutralize [common] [home healthcare]odors [around the house -and/or-at the source -and/or-in homehealthcare]

• Suite -or- Collection -or- Set -or- Selection -or- Assortment ofproducts that [work] together [to] help eliminate -and/or- fight-and/or- control -and/or-neutralize odors on [hard-to-treat] [areaslike] (insert use site/surface) -and/or- hard, nonporous surfaces

• [This product] cleans, shines, deodorizes and disinfects hard,nonporous surfaces -or- insert use site from Table A

RC034021.indd 8 7/2/14 7:59 AM

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r l. .*-. 'lation for the reader and is not part of the label. (Bracketed) f EPA Reg. No. 11346-4 Clorox® QS Page 9 of 17

information and pnrase sequence are opuonai unless specmet^ ,j CFR 156.10. Variables such as CAPITALIZATION, plurals \ ,or singular, bold and italics are optional unless specified in 40 CFR. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (tart) means removed.RC034021

The following is to be used on the home healthcare labeling, "HomeHealthcare"ABN of this product label and/or theeducational kit insert.The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

Disinfection/Pesticidal Claims Continued:

• [This product] is a no rinse disinfectant cleaner that disinfects,cleans and deodorizes in one labor saving step

• [This product] will disinfect hard, nonporous surfaces -or- listany use surfaces: Table A. -or- list any use sites: Table A.

•Tuberculocidal• Use [the] (insert ABN) -or- this product to clean and disinfect high-touch areas.

• Use [this product] to clean and disinfect nonporous [insert usesites/surfaces from Table A]. [Rinse all equipment that comes inprolonged contact with skin before reuse with clean warm water(120°), and allow to air dry. (Cleaning at 120°F temperature will .avoid overheating and distortion of the personal safety equipmentthat would necessitate replacement.)]

• [Virucidalt] [Tuberculocidal] [Bactericidal] [Pseudomonicidal][Fungicidal] [Mildewcidal] [Deodorizer]

**on precleaned hard, nonporous surfaces

Germicidal against the following [organisms]: -or- [This product]kills the following [organisms]: -or- Disinfects against thefollowing [organisms]:

Organisms:See organism list

Note to reviewer: a qualifier will be used if virucidal claimappears on the label

RC034021 .indd 9 7/2/14 7:59 AM

Page 11: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bold, italicized tea and (italicized text within parentheses] i}' lation (or the reader and is not part of the label. (Bracketed] -information and phrase sequence are optional unless specific^ j CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 40 &R. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (tort) means removed.RC034021 •

EPA Reg. No. 11346-4 Clorox®QS Page 10 of 17

Table A - Use Sites/Surfaces:[For use on hard, non porous surfaces [such as]]:

appliance exteriors[baked] enamel[bath] tubs[bathroom] fixturesbed rails/railingbed framesbedpansbedroom[s]bedside commodesbedside tablesbrassbrush handlescabinetscaneschromecommodes[common] hard, nonporoussurfaces

coppercordscounter[top]scrutchesdashboarddesk[s]diagnostic equipment

dialysis machine exteriorsdiaper pailsdining room[s]dish racksdoorknobsexam tablesexterior surfaces of electronic

devicesfloorsFormica®m countertops

-and/or- flooringfreezer exteriorsglassglazed porcelainglucometer exteriorsgrab barsgurneyshome healthcare [settings]homeskitchen[s]laminated surfaceslinoleumliving roommedication cartsoven exteriors

painted surfacespatient chairsprescription containersplasticplastic mattress coversPlexiglass®!"] -or- acrylic glass[portable] bathroom[s]railing[s]refrigerator exteriorfs]remote control exteriorsrespirator exteriorsrocking chairssafety railsscalesscooters (Avoid wetting plug orcharging port by covering with atowel) Note to reviewer:

"(Avoid wetting plug orcharging port by coveringwith a towel)" is notoptional text.

sealed granitesealed woodshopping cartsshower curtains

shower wallsshower[s] -or- shower stallssilversink[s] basinstainless steelsteering wheelstoolsstove exteriorsstretcherssynthetic marbletoilet-exteriors -or- exterior

surfaces of toiletstrash bagstrashcansvanity topsvinylwalkerswallswash basinswheelchairs

pFormica is a [registered] trademark of [The Diller Corporation] [a subsidiary of] [Formica] [Formica Corporation] [or one ormore of its affiliates].]

["Plexiglas is a [registered] trademark of [Arkema, Inc.] [a subsidiary of] [Arkema, Inc.] [or one or more of its affiliates].]

RC034021.indd 10 7/2/14 7:59 AM

Page 12: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Hole: Bald, italicized text and (italicized text within parentheses) is' iation for the reader and is not part of the label. [Bracketed]information and phrase sequence are optional unless specifier - CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 40 OR. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (to*) means removed.RC034021

EPA Reg. No. 11346-4 Clorox® OS Paje 11 of 17

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

Disinfection -or- Disinfects against the following organisms: [(insert contact time from chart):]HOME HEAL THCARE KIT ORGANISM LIST:

:^$^&;*'&&^^

^on^cj ?,:rw&fa. ;:

'• MM .f- ?&- t" .- *, • "."• '3?*i,*iM.*fe5,j ,£**-.~~" 1vSrvT2-'*.t '-i!S' -V 731

^N^MUj ^^^y . fyjfl K''i^-3^^V '"'*L?^:?%*£&;;,': ii"2"- 6fe<*!«aMs'v '€lS^«i

Acinetobacter baumanni

Enterobacter aerogenes

Enterobacter cloacae

Enterococcus faecalis resistant to vancomycin -or- VRE -or-Vancomycin resistant E. faecalis

Escherichia coli [(E. coli)]

Extended Spectrum Beta Lactamase (ESBL)producing Escherichia coli

Klebsiella pneumoniae

Listeria monocytogenes (Listeria)

Pseudomonas aeruginosa

Salmonella enterica

Staphylococcus aureus

Staphylococcus aureus resisitant to methicillin -or-MRSA [(Methicillin resistant S. aureus)] -or- Methicillin-resistantStaphylococcus aureus [(MRSA)]

[ATCC 19606]

[ATCC 13048]

[ATCC 13047]

[ATCC 5 1575]

[ATCC 11 229]

[ATCC

BAA-196]

[ATCC 4352]

[ATCC 191 17]

[ATCC 15442]

[ATCC 10708]

[ATCC 6538]

[ATCC 33592]

2 min[utes]

2 minfutes]

2 min[utes]

2 min[utes]

2 min[utes]

2 minfutes]

2 min[utes]

2 min[utes]

2 min[utes]

2 min[utes]

2 min[utes]

2 minfutes]

Acinetobacter infection

Enterobacter infection

Enterobacter infection

Enterococcus infection

Food-borne illness -or- gastroenteritis

Food-borne illness -or- gastroenteritis

Klebsiella infection

Food-borne illness -or- gastroenteritis

Pseudomonas infection

Food-borne illness -or- gastroenteritis

Staph infection

MRSA Infection -or-Staph infection -or-Antibiotic-resistant Staph infection

Mycobacterium bovis (BCG) -or- TB [(M. bovis)] [OrganonTeknika]

5 min[utes] Tuberculosis

Trichophyton mentagrophytes [ATCC 9533] 10 min[utes] Fungal infection, Athlete's Foot

Continued on next page

RC034021.indd 11 7/2/14 7:59 AM

Page 13: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bolil, italicized text and (italicized text within parentheses) isf 'ation lor the reader and is not part of the label. (Bracketed]information and phrase sequence are optional.unless specified CFR 156.10. Variables such as CAPITALIZATION, pluralsor singular, bold and italics are optional unless specified in 40 Cf rt. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (ted) means removed.RC034021

EPA Reg. No. 11346-4 Clorox® OS Page 12 of 17

The following is to be used on the home healthcare labeling, "HomeHealthcare" ABN of this product label and/or theeducational kit insert.The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i.e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

Disinfection -or- Disinfects against the following organisms: [(insert contact time from chart):]HOME HEAL THCARE KIT ORGANISM LIST continued:

^'i» B .sS.ia.Ssliifcfljiy'iL ,. • Jj*,.-«;^tre.a,r3i*3aw'aJi'-:l*»Jt: .'l -lt.t&^>'^et&i.*t?-^--Z*,"----:. - ~"*:;a fff.i

mHonatitlc A uirnc I7HA\/11[flHepatitis A virus [(HAV)J [University of Ottawa, Canada] 10 min[utes] Food-borne illness -or-gastroenteritis

[fl[Human] Herpes virus [type 2] -or-Herpes Simplex virus [type 2]

[ATCC VR-734, Strain G] 2 min[utes] Genital herpes

[fllnfluenzaAvirus [ATCC VR-544, Strain Hong Kong] 2 min[utes] Flu

Feline Calicivirus (Norovirus virus surrogate) [University of Ottawa, Canada] 30sec[onds]

Norovirus, Food-borne illness-or- gastroenteritis

[flRespiratory syncytial virus [(RSV)] [ATCC VR-26, Strain Long] 2 min[utes] Common cold -or-respiratory infections

[flRhinovirus [type] 37 [ATCC VR-1147, Strain 151-1] 3 min[utes] Common cold

[tjRotavirus [WA strain] 3 min[utes] Gastroenteritis

[flHuman Hepatitis B virus [(as duck HBV)] [(HBV)] [LeGarth strain] 1 min[ute] Hepatitis

[£]Human Hepatitis C virus [(as bovine viral diarrheavirus)] [(HCV)]

[Strain Oregon C24y, - genotype 1] 1 min[ute] Hepatitis

[flHuman Immunodeficiency virus type 1[(Strain HTLV-IIIB] [(HIV-1)]

[HTLV-IIIB strain] 1 minfute] AIDS (AcquiredImmunodeficiency Syndrome)

Virucidalt -or- Virucide^: Note to Reviewer: If the claims "Virucidal" -or-" Virucide" are used,the claim must be qualified by viruses and the qualifying symbol t must be used.

RC034021.indd 12 7/2/14 7:59 AM

Page 14: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Mote: laid, italicized fe*fand (italicized text within parentheses) \y~ tation lor the reader and is not part of the label. [Bracketed] ,-'"" EPA Reg. No. 11346-4 Clorox® OS Page 13 of 17information and phrase sequence are optional unless specifiJ, CFR 156.10. Variables such as CAPITALIZATION, plurals (or singular, bold and italics ire optional unless specified in 40'u rt. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (text) means removed.RC034021

The following is to he used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert. ,

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (I. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

ADDITIONAL HOME HEAL THCARE ORGANISM LIST:

ORGANISMS:

Bacteria:2 minlute] contact time:Acinetobacter calcoaceticus [(A. calcoaceticus)]Bordetella bronchiseptica [(B. bronchiseptica)]

Burkholderia cepacia [(B. cepacia)]Citrobacter freundii [(C. freundii)]Community Acquired Methicillin Resistant Staphylococcus aureus -or- CA-MRSACorynebacterium ammoniagenes [(C. ammoniagenes)]

Enterococcus faecalis [(E. faecalis)]Enterococcus faecium [(E. faecium)]Enterococcus hirae [(E. hirae)]Escherichia coli resistant to tetracycline -or- Tetracycline resistant E. coli

Escherichia coli 0157:H7 [(E. coli)]Flavobacterium -or- Elizabethkingia meningosepticum [(F. -or- E. meningosepticum)]Haemophilus influenzae [(H. influenzas)]

Hafnia alvei [(H. alvei)] 'Klebsiella oxytoca resistant to ampicillin -or- Ampicillin resistant K. oxytoca

Klebsiella oxytoca [(K. oxytoca)]Legionella pneumophila [(L pneumophila)]

Micrococcus luteus [(M. luteus)]

Micrococcus -or- Kytococcus sedentarius [(M. -or- K. sedentarius)]Pasteurella multocida [(P. multocida)]

Proteus mirabilis [(P. mirabilis)]

Proteus vulgaris [(P. vulgaris)]Pseudomonas (Brevundimonas) diminuta [(P. diminuta) -or- (B. diminuta)]

[ATCC 17902][ATCC 10580]

[ATCC 2541 6]

[ATCC 8090]

[NARSA NRS123 genotype. USA400]

[ATCC 6872]

[ATCC 2921 2]

[ATCC 51 559]

[ATCC 10541]

[ATCC 47041]

[ATCC 351 50]

[ATCC 13253]

[ATCC 10211]

[ATCC 11 604]

[ATCC 15764]

[ATCC 131 82]

[ATCC 331 53]

[ATCC 14408]

[ATCC 27573]

[ATCC 12947]

[ATCC 9240]

[ATCC 9920]

[ATCC 131 84]

RC034021.indd 13 7/2/14 7:59 AM

Page 15: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bold, italicized text ant (italicized text within parentheses)'!^ >ation for the reader and is not part of the label. [Bracketed] .'"'" EPA Reg. No. 11346-4 Clorox®QS Page 14 of 17information and phrase sequence are optional unless specific'^ CFR 156.10. Variables such as CAPITALIZATION, plurals (or singular, bold and italics are optional unless specified in 40 CFK. Listed uses and use sites can be used partially or in their ' x

entirety/Highlighted text is new. Strike-through (ted) means removed.RC034021

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

ADDITIONAL HOME HEAL THCARE ORGANISM LIST continued:

ORGANISMS continued:

Bacteria:

2 min[ute] contact time:

Pseudomonas fluorescens [(P. fluorescens)]

Pseudomonas putida [(P. putida)]

Pseudomonas stutzeri [(P. stutzeri)]

Salmonella [enterica - serotype] enteritidis [(S. enteritidis)]-

Salmonella [enterica - serovar] gallinarum [(S. gallinarum)]

Salmonella [enterica - serovar] paratyphi B [(S. paratyphi B)]

Salmonella [enterica - serovar] pullorum [(S. pullorum)]

Salmonella [enterica - serotype] typhi [(S. typhi)]

Salmonella [enterica - serotype] typhimurium [(S. typhimurium)]

Serratia liquefaciens [(S. liquefadens)]

Serratia marcescens [(S. marcescens)]

Shipella dysenteriae [(S. dysenteriae)]

Shigellaflexneri serotype 1B [(S. flexneri)]

Shigella sonnei [(S. sonnei)]

Staphylococcus aureus resistant to erythromycin, penicillin, tetracycline -or- [(Erythromycin,Penicillin, Tetracycline Resistant S. aureus)]

Staphylococcus aureus resistant to vancomycin -or- [(Vancomycin Resistant S. aureus)] (VRSA)

Staphylococcus aureus [subsp. aureus] toxic shock toxin (TS)

Staphylococcus epidermidis resistant to methicillin -or- [(Methicillin Resistant S. epidermidis)]

Staphylococcus haemolyticus [(S. haemolyticus)]

Streptococcus agalactiae [(S. agalactiae)]

Streptococcus mutans [(S. mutans)]

Streptococcus pneumoniae resistant to penicillin -or- [(Penicillin Resistant S. aureus)]

Streptococcus pyogenes (gp A) [(S. pyogenes)]

Xanthomonas [(Stenotrophomonas)] maltophilia [(X. maltophilia)]

Yersinia enterocolitica [(Y. enterocolitica)]

[ATCC 13525]

[ATCC49128]

[ATCC 11 607]

[ATCC 4931]

[ATCC 91 84]

[ATCC 8759]

[ATCC 19945]

[ATCC .6539]

[ATCC 23564]

[ATCC 35551]

[ATCC 14756]

[ATCC 11 835]

[ATCC 9380]

[ATCC 25931]

[ATCC 141 54]

[NARSAVRS1]

[ATCC 33586]

[ATCC 51 625]

[ATCC 29969] ,,

[ATCC 1381 3]

[ATCC 25175]

[ATCC 700677]

[ATCC 19615]

[ATCC 25596]

[ATCC 2371 5]

RC034021 .indd 14 7/2/14 7:59 AM

Page 16: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bold, italicized text and (italicized text within parentheses) \/^ 'ation for the reader and is not part of the label. [Bracketed] /'" EPAReg. No. 11346-4 Clorox®QS Page15of17information and phrase sequence are optional unless specified - CFR 156.10. Variables such as CAPITALIZATION, plurals \or singular, bold and italics are optional unless specified in 40 CHR. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (tent) means removed.RC034021 . •

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABN of this product label and/or theeducational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

ADDITIONAL HOME HEALTHCARE ORGANISM LIST continued:

ORGANISMS Continued:

[Enveloped] Viruses

30 sec[ond] contact time:[flRabies virus [Attenuated ERA strain]S jP^^f^v^^A«<Ss'r-ist:"W^.e«ii*s;J..-'v-:Vii--<-"i. ••". •,v-s.'jS&.;V.:,<..-.-.' •-*..??C.".-. •' ••*•;:'<•.**£.•>"> L': •:••• -.A.V-- •"•• - •- ynffA-:.^T :i; r/\ ^>,t-^8'>--^s 'i-'"*'*v'4'-',Aii'cC:; ^-v^

1 min[ute] contact time:[flCytomegalovirus

[flFeline [viral] rhinotracheitis [virus]

[flHerpes simplex virus type 1

[JJHuman Coronavirus

[^Infectious bovine rhinotracheitis virus

[fl Newcastle disease virus

[flParainfluenza [virus] Type 3

[|]Pseudorabies virus

[flSARS-associated Coronavirus

[^Transmissible gastroenteritis virus (TGE)

[|]Vaccinia virus

[ATCCVR-538, Strain AD-1 69]

[ATCC VR-636, Strain C-27]

[ATCCVR-733, Strain F(1)]

[ATCC VR-740, Strain 229-E]

[ATCC VR-1 88, Strain LA]

[ATCC VR-1 08, Strain B1]

[ATCC VR-93, Strain C243]

[ATCC VR-1 35, Strain Aujeszky]

[ZeptoMetrix]

[Obtained from University of Minnesota]

[ATCC VR-1 19, Strain WR]

2 min[ute] contact time:[IJCanine distemper virus [ATCC VR-1 28, Strain Lederle]

Virucidal^ -or- Virucidet Note to Reviewer: If the claims "Virucidal" -or-" Virucide" are used,the claim must be qualified by viruses and the qualifying symbol t must be used.

RC034021.indd 15 7/2/14 7:59 AM

Page 17: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bold, italicized text ant (italicized text within parentheses) isf 'ation for the reader and is not part of the label. [Bracketed] /^~- EPA Reg. No. 11346-4 Clorox®QS Page 16 of 17information and phrase sequence are optional unless specifiel^ CFR 156.10. Variables such as CAPITALIZATION, plurals • (or singular, bold and italics are optional unless specified in 40 01 n. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (tot) means removed.RC034021

The following is to be used on the home healthcare labeling, "HomeHealthcare " ABM of this product label and/or theeducational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i. e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

n

ADDITIONAL HOME HEALTHCARE ORGANISM LIST continued:

ORGANISMS Continued:

3 min[ute] contact time:

[flAdenovirus type 2

[J]Canine parvovirus

[flFeline Picornavirus

[flPoliovirus

[ATCC VR-846, Strain Adenoid 6]

[ATCCVR-201 7, Strain Cornell][ATCC VR-649, Strain FRV (17-FRV)]

[ATCC VR-1000, Strain Brunhilde]

\*mi$K^?^ f ^£^v il'R^!* XSS^^X1^ ' -.'' 7*.-;s.?s;s >0SKT" V' ;: xJ¥rW \ ^^^ '-y;' ^^^S -ffffl ^£S^S i lim- -a; tfia *' •. • K^ 'mM . i ^^m^^^^m^yS^^K^^Mold, Mildew, Fungi

2 minlute] contact time:

Candida albicans [(C. albicans)] [ATCC 10231]

10 mintute] contact time:

Trichophyton mentagrophytes [(T. mentagrophytes)] (Athlete's Foot Fungus) [ATCC 9533]'

Antibiotic Resistant Bacteria

2 min[ute] contact time:

Community Acquired Methicillin Resistant Staphylpcoccus aureus -or- CA-MRSA

Enterococcus faecalis resistant to vancomycin -or- VRE -or- Vancomycin-resistant E. faecalis

Escherichia coli resistant to tetracycline -or- Tetracyline resistant E. faecalis

ESBL (Extended Spectrum Beta Lactamase) producing Escherichia coli

Klebsiella oxytoca resistant ampicillin -or- Ampicillin resistant K. oxytoca

Staphylococcus aureus resisitant to methicillin -or- MRSA [(Methicillin resistant S. aureus)]

Staphylococcus aureus resistant to erythromycin, penicillin, tetracycline [(Erythromycin, Penicillin,Tetracycline resistant S. aureus)]

Staphylococcus aureus resistant to vancomycin -or- Vancomycin resistant S. aureus (VRSA)

Staphylococcus epidermidis resistant to methicillin Methicillin resistant S. epidermidis

Streptococcus pneumoniae resistant to penicillin -or- Penicillin resistant S. pneumoniae

[NARSA NRS123 genotype USA400]

[ATCC 51 575]

[ATCC 47041]

[ATCC BAA-196] -

[ATCC 15764]

[ATCC 33592]

[ATCC 14154]

[NARSAVRS1]

[ATCC 51 625]

[ATCC 700677]

RC034021.indd 16. 7/2/14 7:59 AM

Page 18: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …€¦ · 01/10/2014  · 11346-4 7/2/14 7/7/14 954579 The following amendment(s), submitted in connection with registration under

Note: Bali, italicized fert and (italicized text within parenthese$)f -mation for the reader and is not part of the label. [Bracketed]information and phrase sequence are optional unless specif?' ,0 CFR 156.10. Variables such as CAPITALIZATION, plurals0! singular, bold and italics are optional unless specified in 40-a'R. Listed uses and use sites can be used partially or in theirentirety. Highlighted text is new. Strike-through (te*») means removed.RC034021

EPA Reg. No. 11346-4 Clorox®QS Page17of17

This information that will appear on home healthcare labeling. The kits will include home healthcare products such as the following:personal care products (e.g. hand sanitizers and antimicrobial hand soap); caregiver protection (e.g. gloves, masks, and gowns); othercleaners or antimicrobial pesticides. The kits will be marketed for various home healthcare needs such as "Germ Kit" and "Clean-Up Kit."

FRONT PANEL

• Kit Name (ABN to be submitted)• Product Name (ABN to be submitted)• Signal Word — Highest category signal word for the products in the kit

on front panel; product specific signal word on back/side panel)• Referral to Side/Back Panel for Additional Precautionary Statements• Keep Out of Reach of Children Statement• Net Weight/Net Contents

IT SEEBACKPttFGWilNALII, PRECAUTIOKTATEBIS,

MEL PANEL POSTERIOR PARA'.DECLARAGIONESPREVENTIVASADICIOiLES,

Kit Contents may include, but are not limited to, the following:

GENERAL/COMPANY INFORMATION SECTION

• Name/Address of Producer or Registrant• EPA Establishment Number

Mfd. The Clorox Company,Packed for The Clorox Company, 1221 Broadway, Oakland, CA 94612.Clorox is a registered trademark of The Clorox Company.CareConcepts is a trademark of The Clorox Company.©2013 Made in the USA.EPAEst. No. 50757-WI-3 (input final facility/co-packer for kit).

SIDE/BACK PANEL

Product Section:• Product Name (ABN to be submitted)• EPA Registration Number• Ingredient Statement• Signal Word• Precautionary Statements• First Aid Statements• Referral to Read the Labels on the Containers

in the Kit for Full Directions for Use

Clorox® CareConcepts™Germicidal Non-BleachSpray/Rbciador, Germicidasin BlanqueadorEPA Reg. No. 11346-4EPA Est. No. 5813-CA-3 (A8 or H8); GA-1 (A4),GA-2'(VG), IL-2 (VF); 8251-OH-1 (Q6), WI-3 (KV), 'WI-5 (UQ); 58455-IN-1 (C6), IN-2 (01); 71681-GA-1(JG), IN-1 (GU), IN-2 (24); 71106-GA-2 (E8)Beginning of batch code indicates Est. No.

ACTIVE INGREDIENTS:n-Alkyl (60% C14, 30% C16,5% C12,5% C18)dimethyl benzyl ammonium chlorides 0.105%n-Alkyl (68% C12,32% C14) dimethylethylbenzyl ammonium chlorides .....0.105%OTHER INGREDIENTS: 99.790%TOTAL: 100.000%

DIRECTIONS FOR USE: It is a violation of Federallaw to use this product in a manner inconsistent withits labeling. See product label for directions for use.

PRECAUTIONARY STATEMENTS: HAZARDS TOHUMANS AND DOMESTIC ANIMALS.

CAUTION: Causes moderate eye irritation. Avoid.. contact with eyes, skin or clothing. Wash thoroughlywith soap and water after handling and before eating,drinking, chewing gum, using tobacco, or using the .toilet. Avoid contact with foods. FIRST AID: IF INEYES: Hold eye open and rinse slowly and gently withwater for 15-20 minute's: Remove contact lenses, ifpresent, after the.fjrst 5 minutes, then continue rinsingeye. IF ON SKIN OR CLOTHING: Take off contaminatedclothing. Rinse skin immediately with plenty of waterfor 15-20 minutes. Call a poison control center ordoctor for treatment &dvice._ Have the productcontainer or label with you when calling a'poisoncontrol center or doctor, or going for treatment. -

RC034021.indd 17 7/2/14 7:59 AM