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### FEB 11 1001 ReckittBenckiser, Inc. 1655 Valley Road Wayne, NJ 

### 07Q47 Subject: Lysol Brand Pre-MoistenBathroom Touch Ups Disinfecting Wipes EPA Reg. No. 777-68 Dear

### Mr. Paolella: Yourecently submitted a label amendmentfor the subjectproductwhich we respondedto 

### on February 9, 2001. There were several label changes required before we could accept that amendment. As a result of that 

### letter we have re-examined the last accepted label for this product and determined that there are some changes that need to be made at your next label printing. These changes are listed below. 1. 

### The product label has use directions as both a sanitizer and disinfectant. However, this product is not approved as a sanitizing rinse 'for previously cleaned food-contact surfaces under 21 CFR 178.1010. Therefore, where there is any mention on the label about use ofthis product to sanitize hard non-porous surfaces thatphrase needs to be qualified to read "... to sanitize hard non-porous non-food surfaces." 2. Your directions for use include recommendations for use 

### in restaurants, kitchens, hotels, schools, homes, hospitals, day care centers to name a few sites. In youruse directions, i.e., "The fast convenient way to clean and disinfect hard surfaces anywhere you travel." you need to add the following language: "Rinse food contact surfaces with a cleanpotable waterrinse afterusing this product." Ifyou have auy questions conceming this letter please me at (703) 308-6233.


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### EFGI Iml mUJ**~soons.**UNIT. STATES ENVIRONMENTAL PROTECTI, AGENCY

Reckitt Benckiser, Inc. 1655 Valley Road Wayne, NJ 

### 07047 

### FEB 092001

Subject: Lysol Brand Pre-MoistenBathroomTouch-Ups Disinfecting Wipes EPA Registration No, 777-68 AmendmentDate: 

### 11110100 EPA Receive Date: 

### 11113/00 Attention: 

### Mr. Bruce Paolella The amendment, referenced above, submitted in connection with registration under FIFRA, as amended, to revise the product label is not acceptable for the following reasons. As perthe Agency letterdated May4, 2000, you 

### will need to verify that the scents listed on your label (Citrus, Summer Fresh, Spring Waterfall, and Country) are actually used in a formulation which has been accepted for this product. Identify to the Agency which scents are associated with which fragrances on an accepted Confidential Statement ofFormulaor delete the scents from the label. This product is not approved for use on toilets. The Agency considers the toilet to include the entire interior as well as the exteriorofthe toilet for which efficacy data has not been submitted to supportdisinfection or sanitization claims. This product is limited to disinfecting or sanitizing the 

### exterior of the toiletor the 

### toilet seat. You must revise the label accordingly. Additional Label Recommendations Page 1: 1. Underthe surface section, the surfaces, "tile" and "porcelain," need to be qualified as hard, non-porous by stating 

### "glazedtile" and 

### "glazedporcelain." In orderto prevent misuse ofthis product, the surface "diaperchanging counters" should be moved to the third column, so the surface can be listed on the same line.

OFFiCiAL FILE COPY**p~** M R,cycl,dPaper The phrase, "and otherhard, non-porous surfaces (anywhere you travel)," mustbe deleted becausethe claim is too broad. Instead, you shouldrevise the claim, 

### "the quick and easy way to (clean and) disinfect (sanitize) " by adding the phrase 

### "thefollowing hard non 

### 2.

EPA Form 132o-1A(119O) 

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,Page 2: 1. The 

### JSI claim must be revised to state "Ready to use, convenient; the quick and easy way 

### to (clean and) disinfect (sanitize) hardnon-porous surfaces such as (toilet seats) (toilet exteriors)." (Remove the parentheses from disinfect which provides consistency with similar claims on the label). 2. The 16 th claim must be revised to state "Disinfects hard, non-porous food contact surfaces such as counters andtables. Aftertreatment rinse with potable water. Do not use this product on utensils, dishes, orglasses. Page 

### 3: 1. Underthe list ofbacteriaand fungi, Trichophyton mentagrophytes 

### should not be listed in parentheses; instead the disease it 

### causes, Athlete's foot fungus should be placed in parentheses.

. 2. Underthe 2nd

### list ofsurfaces, the surface, "porcelain," need to be qualified as hard, nonporous by stating "glazed porcelain." 

### Also, the last phrase, ""and other hard, non-porous surfaces (anywhere you travel)," must be deleted because the claim is too broad. Page 4: 

### 1. The following claims mustbe revised to 

### state: a. The fast convenient way to (clean and) disinfect (sanitize the following hard, nonporous surfaces: (This phrase appears three times) b. For general (cleaning and) disinfecting (sanitizing) hard nonporous surfaces c. Effective disinfecting (sanitizing) has never been faster or easier. 2. Underthe "Directions for Use", you should move the instructions on how to openthe package to 

### appear before the 

### "To clean" directions. 3. You should have separate "to clean" directions for this productbecause the directions are confusing when linked with the sanitizing directions. The heading should state "To clean hardnonporous surfaces such as toiletseats/exteriors." 

### 4. The sanitizing directions should have the heading, "To sanitize non-foodcontact surfaces" 

### and the directions should state "use afresh towelette to thoroughly wetsurface. Allow surface to remain wet for 30 seconds. Allow to airdry. Forheavily soiled surfaces, repeatsanitizing directions."UNITED S rES ENVIRONMENTAL PROTECTIONA**~CY**

COHCURR!HC!!$ SYMBOL



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EPAFonn 132Q-1A (1190) PrinledM R,cycl,dPap" OFFICIAl. FILE COPY

### 5. There is not a need for separate disinfecting directions for toilet seats and bathroom surfaces. The heading should be all inclusive by stating 

### "To Clean/Disinfect hardnonporous bathroom surfaces including toilet seats/exteriors." The directions should state 

### "Use afresh towelette to thoroughly wet surface. Allow surface to remain wet for 10 minutes. Allow to air dry. For heavily soiledsurfaces, repeatdisinfectingdirections." 6. The phrase, "flush or toss the wipe away," contradicts the instructions, "Do not flush down toilet." You will eitherneed to explain to the Agency your intentions in using contradictingphrases or delete references to flushing wipe away. Page 5: !. The first part ofthe HIV statement, "Kills HIV-l .,. bodyibody fluids," should be capitalized, and the 

## mv heading, "Special instructions ... bodyfbody fluids.vshould be in bold according to Subdivision H, Labeling guidelines for Pesticide Use Directions sec. !01-3,p.3!. 2. Underthe disinfection directions, you must add the following: For food contact surfaces such as counters and tables, rinse withpotable water. Do not use on dishes, glasses, orutensils. 3. Since this productmay be used in hospitals, nursing homes, dental/medical facilities on examinationtables, 

### in operatories, on wheel chairs, etc., the following MOU language from PRNotice must be addedto the label. This product is notto be used as a terminal sterilant/high level disinfectant on any surface or instrumentthat (1) is introduced directly into the human body, either into orin contact withthe bloodstream or normally sterile areas ofthe body, or (2) contacts intact mucous membranes but which does not ordinarilypenetrate the blood barrier or otherwise enter normally sterile areas ofthe body. This product may be usedto pre-clean or decontaminate critical or semi-critical medical devices priorto sterilization. You should submitfive (5) copies ofthe revised label addressing the above comments for the Agency to review. Ifyou have any questions regarding this letterplease contact Jacqueline McFarlane at (703) 308-6416. 

# ,sr;:1WJ»-**~~lmaNOble** Product Manager (31) Regulatory Management BranchI Antimicrobials Division (751 DC)UNITED S rES ENVIRONMENTAL PROTECTIOH A**.~CY**



# 1

OFFICIAL FILE COPY EPA Form 1320-1A (1190) COHCURRI:NCI!:$ SYMBOL 

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# r Please read instructionson reverse beforeco, ling form. 05-31-98 

# '--. \i [''.m Approved: OMS No. 2070·0060, Approval expires 

# 'G,EPA United states 0 Registration Environmental Protection Agency X Amendment Washington, DC 20460 

## 0 Other opp Identifier Number
Application for Pesticide
- Section I
r. CompanylProduct Number 777-68 2, EPA Product Manager Velma Noble 3. Proposed Classification

Product Name 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) (b)(I), my product is similar or identical in composition and labeling to: EPA Reg. No.

## --------------'---1 4. CompanylProduct (Name)

LysolBrandPre--MoistenedBathroom ToucnUps Disinfecting Wipes 5. Name and Address of Applicant (Include ZIP Code) Reckitt Benckiser Inc. 1655 Valley Road Wayne, NJ 07474 

# o Check ifthis is a new address PM' 31**~None** 

# o Restricted

Section -II Amendment - Explain below. 

# o Resubmission in response to Agency letter dated'

_ 

# o Notification - Explain below. 

# o Final printed labels in response to Agency letter dated _ 

# o "Me Too" Application 

### [gJ Other - Explain below Explanation: Use additional page(s) if necessary. (For Section I and Section II.) Amendment Revision of Product label Section III
2. Type of Container 

# o Metal 

### [;8] Plastic 

# o Glass 

# o Paper 

# o Other (Specify) No. per container
5. location of label Directions 

## 12J On label 

# o On labeling accompanying product Printed on package 

# o Other Water Soluble Packaging DYes 

## IZJ No If "Yes" Package wgt. No. per container



# o lithograph 4. Size(s) Retail Container Material This Product Will Be Packaged In:

*Certification must 

### txesuomtttea

6. Manner in Which Label is Affixed to Product 3. location of Net Contents Information 

## l:8J Label 

## 0 Container Child-Resistant Packaging Unit Packaging 

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## 0 Yes 

## IZJ No 

## IZJ No**I-~'~f ·~Y~e~,·;""----",;-;;;;;--I-"''''';;-----",;-;;;;,---\**  Unit Packaging wgt.



### r.8l Paper glued 

# o Stenciled Section -IV 1. Contact Point (Comple/e items directlybelOw foridentification ofindividualto be confacted, ifnecessary, toprocess this application)
973·686-7391 Name TItle Telephone No. (Include Area Bruce Paolella Senior Regulatory Affairs Specialist Code) Certification I certify that the statements I have made on Ihis form and all attachments thereto are true, accurate and complete. I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both underapplicable law. 6. DaleApplication Received (Stamped) 3. TItle Senior Regulatory Affai/sSpecialist 

## ., 4., Typed

....ame Bruce Paolella 5. Date November 10, 2000 EPA Form 8570-1 (Rev. 8·94) Previous editions are obsolete white- EPA File Copt (original; venow- ApP'lcant**~opy**

,.

# RE(](ln BEN(]{ISER

November 10, 2000 Document Processing Desk (AMEND) Office ofPesticide Programs (7504C) 

### U.S. Environmental Protection Agency Room 266A, Crystal MaU2 

### 1921 Jefferson-Davis Highway Arlington, Virginia 22202-450I Attn: Velma Noble PM-31


### RE: Lysol Brand Pre-Moistened Bathroom Touch-Ups DisinfectingWipes EPA Registration Number 777-68 Label Amendment for Approved Efficacy Claims and Use Directions Dear Ms. Noble: Reckitt Benckiser Inc. would like to revise the product master label associated with the above registration. The revisions made relate to already approved efficacy claims for disinfection and sanitization. In addition, we have revised our Use-Directions and the "To Open Package" directions for clarification purposes. In support ofthis amendment please find the following documentation. 1) EPA Application for Pesticide Registration Form 8570-1, 

### OPP Identification number 263614. 2) Six (6) copies ofthe proposed label. As mentioned above, there is no efficacy data related to the additional claims since all the data for disinfection and sanitization has already been approved by the Agency. Ifthere is any other information needed to complete this amendment, please feel free to contact me at 973-686-7391. 1thank you for assisting us with this revision.

};, 'ncereI Y

,

# B If) I -'----

# ~~**r~aolela** Sr. Regulatory Affairs Specialist

RECK ITT BENCKISER INC. 1,55 Valley Road, P.O.**Bo~** 943, W.yne. NJ 07474.0943 TEL' (973J-633-3600 FAX, (973)-633-3633



### • 

# .-.Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes EPA Registration Number: 777-68 Page: Revised: ] 0/03/00

New* Lysol ® Brand
Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes Contents 16Individually Wrapped Pre-Moistened Towelettes (8" x 5 3;"") (Box)
20 (25) (35) Pre-Moistened Towelettes (8" x 5 3/.")(7" x 8") (Pouch) 25 (35) Pre-Moistened Towelettes (7 W' x 10) (Canister) Ready to Use (Economy Size) (Bonus Size) (Tra"vel Size) (Pack) (Citrus) (SummerFresh) (Spring Waterfall) (Country) (Scent) HOSPITALS NURSING HOMES CLINICS DENTAL OFFICES SCHOOLS VETERNIARY OFFICES HOTELS RESTAURANTS DAY CARE CENTERS PHYSICIAN OFFICES HEALTH CLUBS AMBULANCES BOWLING ALLEYS AIRPORTS MALLS GAS STATIONS PUBLIC REST ROOMS PUBLIC TELEPHONES DIAPERCHANGING COUNTERS KENNELS The quick and easy way to (clean and) disinfect (sanitize) Toilet Seats Kitchen, Bathroom Laundry Room Walls, Floors Diaper ChangingS+/I-·hop ..$ Counters Table Tops Toilets, Sinks Showers, Tubs Tile, Enamel Porcelain Garbage Cans Diaper Pails Counter Tops Nursery Telephones Cabinets Storage areas PetAreas High Chairs -,

• Quick
• Convenient

• Portable
ACTIVE INGREDIENT: Alkyl (50% c 14,40%, CI2, 10% CI2) Dimethyl Benzyl Ammonium Chlorides 0.28% INERT INGREDIENTS 99.72% TOTAL 100.000/0 EPA Reg. No. 777-68 EPA Est. No. 777-IL-l, 777-NJ-2, 05263I-NJ-00I, 777-NY-OOI *WilI only be used for 6 months from date ofintroduction (Resealable Pouch Inside)

Keep Out ofReach OfChildren CAUTION: See Panel for additional Precautionary Statements»

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••••Lyse! Brand Pre-Moistener! Bathroom Touch-Ups Disinfecting Wipes EPA Registration Number: 777-68

Box (Pouch) (Canister) Label
ALTERNATE LANGUAGE Optional Disinfectancy Related - bullets/bursts/sentences - Front or Back Panel Page: 2 Revised: 10/03/00

Ready to use, convenient; the quick and easy way to (clean and) {disinfect)(sanitize) (toilet) (seatsr(and other) hard surfaces. Kills (99.9%) (of) household (bacteria) in 30seconds. Kills (99.9% of) (bacteria) (germs) in 30 seconds." Hospital Type (disinfectant) (disinfection). Starts killing (bacteria) (genns) on contact. Kills (more than

- or - even greater than - or

- » (99.99%) ofhousehold germs - and / or- bacteriaand/or- viruses-v -and/or- fungi -and/or- mold. Kills (more than-or- even greater than -or- » 99.9% ofhousehold germs such as (Salmonella choleraesuis) Salmonella - (Staphylococcus aureus) Staph - (Pseudomonas aeruginosa) Pseudomonas- (Trichophyton mentagrophytes) Athletes foot fungus and (Enterococcus) (Streptococcus) (faecalis). Kills 99.9% of(Staphylococcus aureus) (Staph) (Klebsiella pneumoniae) in 30 seconds. Sanitizes (Kitchen) (Household) (Bathroom) surfaces in 30 seconds. Kills (99.9%) of(bacteria) (genns) (viruses**) in 30 seconds. Kills (kitchen) (household) (bathroom) (germs) (bacteria) (viroses-e) (fungi) (mold). Disinfects -or- kills common household germs -and/or- bacteria-and/or- vlrusesv'' -and/or- fungi -and/ormold .

•• Viruses: Influenza A2 (Japan), Herpes Simples Type 1. An effective disinfectant (sanitizer) for use in kitchen, bathroom, bedroom, and other(household) areas. This product is a rnildewstat and will effectively inhibit the growth ofmildew on hard non-porous surfaces. Disinfects hard non-porous foodcontact surfaces. An- I:'. 'P •.fl' ""rAJ.**,RIIJ6~'** Ki**~';!T:O-!.,;;..G** HrJ' , De 1,),,-;- '.<: Lysol Brand Pre-Moistened Bathroom Touch-ups Disinfecting Cleaning Wipes Kill the following bacteria, viruses and fungi:

Note: Bracketed () information is option ions. 

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### • • •••••Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes EPA Registration Number: 777*68

Bacteria & Fungi: Staphylococcus aureus (Staph) Enterococcus (Streptococcus) faecal is Salmonella choleraesuis (Salmonella) Pseudomonas aeruginosa Athletes foot fungus (Trichophyton mentagrophytes) Mold and Mildew Klebsiella pneumonia Viruses: Herpes Simplex Type I Human Immunodeficiency Virus Type 1 (HIV - I) Influenza A2 (Japan) Optional Disinfectancy Related

- bullets/bursts/sentences - Front or Back Panel Page: Revised: 10/03/003

One Step (Cleaning and) Disinfecting Hospital, Nursing Home, Clinic(s), Dental Office(s), School, Veterinary Office (s)" Bowling Alley, Hotel, Restaurant, Day Care Center, Physician's Office, Health Club, Ambulance, Kennel (s), Airport, Malls, Gas Station, Public Restroom(s), Public Telephone, Diaper Changing Counter(s), Kitchen, Bathroom, Household (Disinfectant) (Sanitizer). (Disinfects) (Sanitizer): Toilet Seats, Kitchens, Bathrooms, Laundry Rooms, Walls, Floors, Diaper Changing Counters, 'ftIJIM:Ms, Sinks, Showers, Tubs, Glazed Tile, Enamel, glazed Porcelain, Garbage Cans, Diaper Pails, Nursery, Telephones, (Non wood)(Finished) Cabinets, Storage Areas, Pet Areas, Non-wood High Chairs, Table tops, counter tops (counters). The quick and easy way to (clean and) disinfect (sanitize). Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes (clean and) (disinfect) (sanitize) the following surfaces: Toilet Seats, Kitchens, Bathrooms, Laun Rooms, Walls, Floors, DiaperChanging**Counters,~,** Sinks, Showers, Tubs, Gla ile, Enamel orcelain, Garbage Cans, Diaper Pails, Nursery, Telephones, Cabinets, Storage Areas, Pet Areas, Non-wood High Chairs, Table tops, countertops (counters) (and other bard pOP"PoTQnS surfaces (aR'}'

.....i1ere Ylla !tavel). Quick Portable Convenient Easy to Use Great for touch-up cleaning Easy to carry around the house Not for personal hygiene For use on Household surfaces only Lysol Brand Pre-Moistened Bathroom Touch-Ups Dtstntecnng Cleaning Wipes are the convenient • way to (clean and) disinfect (sanitize) household surfaces. Each pre-moistened, disposable**wipe:~nrs··** germs - even the germs that cause odors. Great for use in your kitchen, bathroom, and throughout the.

# . house. • o Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes are also great

## on,b;.:. "go" in restaurants, public restrooms, public telephones, ordiaperchanging stations. •

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### •••• ••••Lysol Braud Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes Page: 4 EPA Registration Number: 777-68 (Back) New* Lysol Brand pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes (Travel Size) The fast convenient way to (clean) and**~isinfec~** (sanitize) hard non-porous surfaces anywhere (you) (travel). Use them onbathroom surfaces, toilet seats, and telephones in malls restaurants, gas stations, airports, rest stops, and (public) (places) (facility) where germs or bacterial may be ofconcern. ALTERNATE LANGUAGE The (fast) (convenient) way to (clean) and(disinfect) (sanitize) hard non-porous surfaces. Use them in toilet areas, under sinks, sick rooms, showers, bath tubs, patient chairs, examination tables, garbage pails, operatortes, stretchers, laboratories, cuspidors, door handles, wheel chairs, counters, and other places where germs, or bacteria may be a concern

.. New" Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes are the convenient way to (clean) (and) (disinfectj(sanitize) hard non-porous surfaces. For general (cleaning) (and)**~isinfectingl(sanitizing)** hard non-porous surfaces. New*Lysol BrandPre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes are the (convenient) way to (clean) (and) disinfect (sanitize) your household surfaces. Each pre-moistened disposable wipe**(~heatu1** ,,\Wta**~eeiBI cleaiiej~** **t\et:[l~tU')')** kills germs - even the germs that cause odors - wherever you use it. No bottles, no sponges, no mess. Effective (disinfecting) (sanitizing) has never been faster or easier. Unplug small electrical appliances before (use) (cleaning) (disinfecting) (with this product). Not recommended for polished or bare wood surfaces. Directions for Use: It is a violation of federal law to use this product in a manner inconsistent with its
( labeling. TO (CLEAN) (AND) S! 

### pi i. HARD SURFACES (INCLUDING TOILET SEATS): Use a fresh toweletteto wipe surface. (Flush) or (Toss) dirty wipe away. I 

### -ro**s."'-~,-n't.£** 

### ; : Allow surface to remain wet for 30 seconds. To sanitize heavily soiled surfaces, repeat with a clean . towelette. Not intended for personal hygiene.

(Do not Flush Down Toilet) TO (CLEAN) (AND) (DISINFECT) OTHER BATHROOM SURFACES: Use a fresh towelette according to directions above. (Flush) or (Toss) dirty wipe away. TO (CLEAN) (AND) (DISINFECTTOILET SEAT: Use a fresh towelette to wipe toilet seat. (Flush dirty wipe away). Allow surface to remain wet for 10 minutes. To disinfect heavily soiled surfaces, repeat with a clean towelette.



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# · . " NOIe: Bracketed () information is optionaltext. Textseparated by a comma ( ,) denotesand/Oroptions. Pull up tab and remove large cover. Remove inner tab loop from cover hinge. Insert loop into opening. Thread first sheet in center ofroll through loop. Replace cover. Pull loop back through opening.**P~lo~** 

### • sheet up and slightly to the side. Always snap lid securely shut between uses to prevent moisture**los~.** • 

### •••••• 

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•••••Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes Page: 5 EPA Registration Number: 777-68 Revised: 10/03/00

Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes meets efficacy standards for (hospital type) disinfectant (sanitizing) wipes. Kills Influenza A2 and Herpes Simplex Type I viruses and Enterococcus (streptococcous) faecalis germs. Inhibits mold and mildew in damp and musty places. [Kills Human Immunodieficiency Virus Type I (HIV-I) (AlDS virus) on precleaned environmental surfaces/objects previously soiled with blood/body fluids in health care settings or other sertingsjin which there is an expected likelihood ofsoiling ofinanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission ofHuman Immunodeficiency virus type I (HlV-I) (associatedwith AIDs). ["Special instructions for Cleaning and Decontamination Against HlV-I ofSurfaces/Objects soiled with

Blood/Body FIuidsJ Personal Protection: When handling items soiled with blood or body fluids, use disposable latex gloves, gowns, masks or eye coverings. Cleaning Procedures: Thoroughly clean blood and other body fluids from surfaces and objects with wet towelette. Use second towelette to disinfect. Contact Time: Allow to stand 10minutes. Disposal oflnfectious Material: Blood and other body fluids should be autoclaved and disposed of according to local regulations for infectious waste disposal. ALTERNATE DIRECTIONS FOR USE: To Open Package: Open cap lid and pull up firmly on lid to remove the entire cap from the canister. Locate wipe at the center ofthe roll and insert comerofwipe through opening in lid. DO NOT PUSH FINGER THROUGH OPENING. Replace lid. Pull sheet up and slightly to side. Always snap lid securely shut between uses to prevent moisture loss. To Sanitize Hard Non-Porous Surfaces: Use a fresh towelette to wipe surfaces. Toss dirty wipe away. Do not flush down toilet. Allow surface to remain wet for 30 seconds. To sanitize heavily soiled surfaces, repeat with a clean towelette. NOT INTENDED FORPERSONAL HYGIENE. To Disinfect Hard Non-Porous Surfaces: Use a fresh towelette. Wipe surface and allow to remain wet for 10minutes. Toss dirty wipe away. Do not flush down toilet. To disinfect heavily soiled surfaces, repeat with a clean towelette. \..J**H;;~l** l.-"::,(' ,) i'" ;2C**'c~\>0,j** f; IS',<-"

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••••Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes EPA Registration Number: 777-68 PRECAUTIONARY STATEMENTS: HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION: May cause eye irritation. Avoid contact with eyes. Wash hands after use. Page: 6 Revised: 10/03/00

First Aid: In case ofeye contact, IMMEDlATELY flush eyes thoroughly with water, remove any contact lens, and continue to flush eyes with plenty ofwater for at least 15 minutes. Call physician if irritation persists. Storage /Disposal: Disposeofwipe in trash after use. Do not flush. Close lid between uses to retain moisture. Do not reuse empty container. Offer empty container for recycling. lfrecycling is not available, discard container in trash.

(BACK) (Packet Label) Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes

ACTIVE INGREDIENT, Alkyl (50% c 14,40%, C12, 10% C12) Dimethyl Benzyl Ammonium Chlorides 0.28% INERT INGREDIENTS '" 99.72% TOTAL 100.000/" Does not include weight ofdry wipe See outer container for additional precautions and directions for use.
CONTAINER DISPOSAL: Discard empty envelope in trash EPA Reg. No. 777-68 EPA Est. No. 52631-NJ-OOI Keep Out ofReach Of Children CAUTION: See Panel for additional Precautionary Statements

Net Contents: One Towelette
Reckitt Benckiser Inc. 1655 Valley Road Wayne, New Jersey 07474

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New" Lysol ® Brand
Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes Contents 16Individually Wrapped Pre-Moistened Towelettes (&" x 5 Yo") (Box) 20 (25) (35) Pre-Moistened Towelettes (8" x 5 J,{")(7" x 8") (Pouch) 25 (35) Pre-Moistened Towelettes (7 Yz" x 10) (Canister) Ready to Use (Economy Size) (Bonus Size) (Travel Size) (Pack) (Citrus) (SummerFresh) (Spring Waterfall) (Country) (Scent) HOSPITALS NURSING HOMES CLINICS DENTAL OFFICES SCHOOLS VETERNIARY OFFICES HOTELS RESTAURANTS DAY CARECENTERS PHYSICIAN OFFICES HEALTH CLUBS AMBULANCES BOWLING ALLEYS AIRPORTS MALLS GASSTATIONS PUBLIC RESTROOMS PUBLIC TELEPHONES DIAPER CHANGING COUNTERS KENNELS The quick and easy way to (clean and) disinfect (sanitize) Toilet Seats Kitchen, Bathroom Laundry Room Walls, Floors DiaperChangingS+II-+'o<:s Counters Table Tops Toilets, Sinks Showers, Tubs Tile, Enamel Porcelain Garbage Cans Diaper Pails CounterTops Nursery Telephones Cabinets Storage areas Pet Areas High Chairs
And otherhala ftOfl·pl're1l5 s'oIrfaces (al'l)'where yell tril"ef). • Quick
• Convenient • Portable
ACTIVE INGREDIENT: Alkyl (50% c 14,40%, C12, 10% CI2) Dimethyl Benzyl Ammonium Chlorides 0.28% INERT INGREDIENTS 99.72% TOTAL I00.000/0 EPA Reg. No. 777-68 EPA Est. No. 777-IL-I, 777-NJ-2, 052631-NJ-OOI, 777-NY-00I *WilIonly be used for 6 months from date ofintroduction (Resealable Pouch Inside)

Keep Out ofReach OfChildren CAUTION: See Panel for additional Precautionary**StatelJlent~·.** 

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Box (Pouch) (Canister) Label
ALTERNATE LANGUAGE Optional Disinfeciancy Related - bulletsfbursts/sentences - Front or Back Panel Page: 2 Revised: 10/03/00

Ready to use, convenient; the quick and easy way to (clean and) tdisinfect}(sanitize) ttoilet) (seatsl(and other) hard surfaces. Kills (99.9%) (of) household (bacteria) in 30 seconds. Kills (99.9% of) (bacteria) (germs) in 30 seconds. Hospital Type (disinfectant) (disinfection). Startskilling (bacteria) (germs) on contact. Kills (more than - or- even greater than

- or- » (99.99%) ofhousehold germs - and / or- bacteriaand/or- viruses** -end/or- fungi -and/or- mold. Kills (more than --or- even greater than -or- » 99.9% ofhousehold germs such as (Salmonella choleraesuis) SalmonelJa - (Staphylococcus aureus) Staph - (Pseudomonas aeruginosa) Pseudomonas- (Trichophyton mentagrophytes) Athletes foot fungus and (Bnteroccccus) (Streptococcus) (faecalis). Kills 99.9% of(Staphylococcus aureus) (Staph) (Klebsiella pneumoniae) in 30 seconds. Sanitizes (Kitchen) (Household) (Bathroom) surfaces in 30 seconds. Kills (99.9%) of(bacteria) (genns) (v.iruses**)in 30 seconds. Kills (kitchen) (household) (bathroom) (germs) (bacteria) (virusesv") (fungi) (mold). Disinfects -or- kills common household germs -and/or- bacteria -and/or- virusesv" -and/or- fungi -and/ormold.

** Viruses: Influenza A2 (Japan), Herpes Simples Type 1. An effective disinfectant (sanitizer) for use in kitchen, bathroom, bedroom, and other (household) areas. This product is amildewstatand will effectively inhibit the growth ofmildew on hard non-porous surfaces. Disinfects hard non-poraus foadcontact surfaces.**A,nn~,** ",!'';Ll<fi'iai';")',' , RaJ!;"" g! F;"n·I'''''-i.{ I-h(::'. Do**~.Jii-J-** l'Se en (/H!l5h (
... , (/,,,-,,/,.,';O.p <:.,'-::" '.;, '''''',:.ktS Lysol Brand Pre-Moistened Bathroom Touch-ups Disinfecting Cleaning Wipes Kill the following bacteria, viruses and fungi:

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Bacteria & Fungi: Staphylococcus aureus (Staph) Enterococcus (Streptococcus) faecalis Salmonella choleraesu is (Salmonella) Pseudomonas aeruginosa Athletes foot fungus (Trichophyton mentagrophytes) Mold and Mildew Klebsiella pneumonia Viruses: Herpes Simplex Type I
. Human ImmunodeficiencyVirus Type I (HIV 1) Influenza A2 (Japan) Optional Disinfectancy Related

- bullets/bursts/sentences

- Front or Back Panel Page: Revised: 10/03/003

One Step (Cleaning and) Disinfecting Hospital, Nursing Home, Clinic(s), Dental Office(s), School, Veterinary Office (S)'I Bowling Alley, Hotel, Restaurant, Day Care Center, Physician's Office, Health Club, Ambulance, Kennel (s), Airport, Malls, Gas Station, Public Restroomts), Public Telephone, Diaper Changing Counter(s), Kitchen, Bathroom, Household (Disinfectant) (Sanitizer). (Disinfects) (Sanitizer): Toilet Seats, Kitchens, Bathrooms, Laundry Rooms, Walls, Floors, Diaper Changing Counters,**~s,** Sinks, Showers, Tubs, GlazedTile, Enamel, glazed Porcelain, Garbage Cans, Diaper Pails, Nursery, Telephones, (Non wood)(Finished) Cabinets, Storage Areas, Pet Areas, Non-wood High Chairs, Table tops, countertops (counters). The quick and easy way to (clean and) disinfect (sanitize). Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes (clean and) (disinfectj (sanitize) the following surfaces: Toilet Seats, Kitchens, Bathrooms, Laun Rooms, Walls, Floors, Diaper Changing**Counters,~,** Sinks, Showers, Tubs, Glaz I e, Enamel orcelain, Garbage Cans, Diaper Pails, Nursery, Telephones, Cabinets, Storage Areas, Pet Areas, Non-wood High Chairs, Table tops, counter tops (counters) (aqclother bard non_porousSlJrfuces**(a~Waefe** Y"O baQeI). Quick Portable Convenient Easy to Use Great for touch-up cleaning Easy to carry around the house Not forpersonal hygiene For use on Household surfaces only Lysol Brand Pre-Moistened Bathroom TOUCh-Ups Dtsmtecnng Cleanmg Wipes are the convenlean • way to (clean and) disinfect (sanitize) household surfaces. Each pre-moistened, disposable wipe:IHl.ts·· germs - even the germs that cause odors. Great for use in your kitchen, bathroom, and throughout the• •••••• house. • 

### • Lysol Brand Pre-Moistened Bathroom TOUCh-Ups Disinfecting Cleaning Wipes are also great

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### • •Lyso l Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes Page: 4 EPA Registration Number: 777-68 (Back) New* Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes (Travel Size) The fast convenient way to (clean) and**fdisinfec~** (sanitize) hard non-porous surfaces anywhere (you) (travel). Use them on bathroom surfaces, toilet seats, and telephones in malls restaurants, gas stations, airports, rest stops, and (public) (places) (facility) where germs or bacterial may be ofconcern. ALTERNATE LANGUAGE The (fast) (convenient) way to (clean) andt\lisinfel."1:)(sanitize) hard non-porous surfaces. Use them in toilet areas, under sinks, sick rooms, showers, bath tubs, patient chairs, examination tables, garbage pails, operatories, stretchers, laboratories, cuspidors,doorhandles, wheel chairs, counters, and other places where germs, or bacteria may be a concern: New* Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes are the convenient way to (clean) (and) (disinfecd(sanitize) hard non-porous surfaces. For general (cleaning) (and)**~isinfeeting}(sanitizing)** hard non-porous surfaces. New*Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes are the (convenient) way to (clean) (and) disinfect (sanitize) your household surfaces. Each pre-moistened disposable wipe (i-s heated 1\ilk a sfle<sial c1CMn!l1flat**!lettt~lIy)** kills germs - even the germs that cause odors wherever you use it. No bottles, no sponges, no mess. Effective (disinfecting) (sanitizing) has never been faster or easier. Unplug small electrical appliances before (use) (cleaning) (disinfecting) (with this product). Not recommended for polished or bare wood surfaces. Directions for- Use: It is a violation offederal law to use this product in a manner inconsistent with its . labeling. 

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### o vnae : Allow surface to remain wet for 30 seconds. To sanitize heavily soiled surfaces, repeatwith a clean towelette. Not intended for personal hygiene. TO (CLEAN) (AND) (DISINFECT TOILET SEAT: Use a fresh towelette to wipe toilet seat. (Flush dirty wipe away). Allow surface to remain wet for IO minutes. To disinfect heavily soiled surfaces, repeat with a clean towelette. TO (CLEAN) (AND) (DISINFECT) OTHER BATHROOM SURFACES: Use a fresh towelette according to directions above. (Flush) or (Toss) dirty wipe away. (Do not Flush Down Toilet)

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e label.Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes Page: 5 EPA Registration Number: 777-68 Revised: 10/03/00

Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes meets efficacy standards for (hospital type) disinfectant (sanitizing) wipes. Kills Influenza A2 and Herpes Simplex Type I viruses and Enterococcus (streptococcous) faecalis germs. Inhibits mold and mildew in damp and musty places. [Kills Human Immunodieficiency Virus Type I (HIV-I) (AIDS virus) on precleaned environmental surfaces/objects previously soiled with bloodlbody fluids in health care settings or other settingsjin which there is an expected likelihood ofsoiling of inanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission ofHuman Immunodeficiency virus type I (HIV-I) (associated with AIDs). [""Special instructions for Cleaning and Decontamination Against HlV-I ofSurfaces/Objects soiled with

Blood/Body FlUidS.] Personal Protection: When handling items soiled with blood or body fluids, use disposable latex gloves, gowns, masks or eye coverings. Cleaning Procedures: Thoroughly clean blood and other body fluids from surfaces and objects with wet towelette. Use second towelette to disinfect. Contact Time: Allow to stand 10 minutes. Disposal ofInfectious Material: Blood and other body fluids should be autoclaved and disposed of according to local regulations for infectious waste disposal. ALTERNATE DIRECTIONS FOR USE: To Open Package: Open cap lid and pull up firmly on lid to remove the entire cap from the canister. Locate wipe at the centerofthe roll and insert corner ofwipe through opening in lid. DONOTPUSH FINGER THROUGH OPENING. Replace lid. Pull sheet up and slightly to side. Always snap lid securely shut between uses to prevent moisture loss. To Sanitize Hard Non-Porous Surfaces: Use a fresh towelette to wipe surfaces. Toss dirty wipe away. Do not flush down toilet. Allow surface to remain wet for 30 seconds. To sanitize heavily soiled surfaces, repeat with a clean towelette. NOT INTENDED FOR PERSONAL HYGIENE.

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.....-..-",...;;",y,e" Veterinary Practice/Kennels/Animal Care Facilities: For disinfecting hard, non-porous surfaces including equipment, utensils, cages, kennels, instruments etc. Remove all animals and feeds from the premises, crates, cages, and enclosures. Remove all litter, droppings, and manure from floors, walls, and surfaces occupied or traversed by animals. Empty all troughs, racks and other feeding/watering appliances. Thoroughly clean surfaces with soap ordetergent and rinse with water. Saturate surfaces and allow to stand 10 minutes. Ventilate buildings and other closed spaces. Do not house animals or employ equipment until treatment has been absorbed, set, and dried. Thoroughly scrub all treated feed racks, automatic feeders, and watering appliances with soap or detergent, and rinse with portable water before use.Lyse! Brand Pre-Moistened Bathroom Touch-Ups Disinfccting Wipes EPA Registration Number: 777-68 PRECAUTIONARY STATEMENTS: HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION: May cause eye irritation. Avoid contact with eyes. Wash hands after use. Page: 6 Revised: 10/03/00

First Aid: In case ofeye contact, IMMEDIATELY flush eyes thoroughly with water, remove any contact lens, and continue 10flush eyes with plenty of water for at least IS minutes. Call physician if irritation persists. Storage /Disposal: Disposeofwipe in trash after use. Do not flush. Close lid between uses to retain moisture. Do not reuse empty container. Offer empty container for recycling. If recycling is not available, discard container in trash.

(BACK) (Packet Label) Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes

ACTIVE INGREDIENT: Alkyl (50%c I4,40%,CI2, IO%CI2) Dimethyl Benzyl Ammonium Chlorides 0.28% INERT INGREDIENTS 99.72% TOTAL 100.00% Does not include weight ofdry wipe See outer container for additionaI precautions and directions for use.
CONTAINER DISPOSAL: Discard empty envelope in trash EPA Reg. No. 777-68 EPA Est. No. 52631-NJ-OOI Keep Out ofReach OfChildren CAUTION: See Panel for additional Precautionary Statements

Net Contents: One Towelette
Reckitt Benckiser Inc. 1655 Valley Road Wayne, New Jersey 07474

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### Household Products Division Reckitt & 

### ColmanInc. 1655 Valley Road Wayne, NJ 07474 ATTENTION: Bruce Paolella SUBJECT: 

### Lysol®Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes EPA Registration Number777-68 

### Amendment forAlternateFormulations YourAmendment Dated: March 1, 2000 EPAReceived Date: March 1, 2000 This is to acknowledge receipt ofyour 

### amendment to add alternateformulations for this 

### product. TheConfidential Statements ofFormula 

### (C.s.!'s) for theAlternate Formulations ! (Formulas #656-130, 656-131, 656-132, and 656-133) dated 3/1/2000 bas been reviewed and



### have beenfound 

### to be acceptable withthefollowing conditions. The Agency has revised the CSFs for formulations 656-130, 656-131, and 656-132 to 

### include thename associated withReg. ' Inaddition based on our phone

### c~nversation with youwe have corrected formulation 656-133

# i6 include the following address

### for

- . , Makethesesame revisions to the CSFs in your files. These CSFs will be made part ofthe record for this file. 

### Should you haveanyquestions concerning thisletter, please contact TracyLantz at (703) 308-6415.

OFFICIAL. FILE COPY

# rJi~!# Velma Noble ProductManager (31) 

### RegulatoryManagement BranchI

EPAForm 1320-1A (1190) COKCURR!!HCzfuxtimiwvbials Division (75106) SYMBOL. 

## t 7510C:T. antz:5/12/00: 177-68c
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## '.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF PREVENTiON, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: ProductChemistry Review of Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes DP Barcode: D263852 Manufacturing-use [ ] Reg. No. or File Symbol: 777-68 End-use Product [X] Active Ingredient Composition: Alkyl (50% C14, 

### 40% C12, 

### 10% C16) 

### dimethyl benzyl ammonium chlorides 0.28%



### TO: VelmaNoble PM 31 FROM:

THRU:

THRU: Alex Traska, Chemist ProductScience Branch, CTTeam Antimicrobials Division (751 DC)



### Karen P. Hicks, CT Team Leader Product ScienceBranch Antimicrobials Division (751 DC) 

### Michele E. Wingfield, Chief ProductScience Branch Antimicrobials Division (751 DC) 

### BACKGROUND: This submission, forthe subject disinfecting wipes, was submitted by the registrant, Rickett & 

### Colman Inc.

### DP BARCODE, D263852 CASE, 008454 DATA PACKAGE RECORD DATE, 03/07/00 SUBMISSION: 8576398 BEAN SHEET Page 1 of 1


## * * * CASE/SUBMISSION INFORMATION 

### * 

## * * CASE TYPE, REGISTRATION ACTION, 363 RESUB FQPA-TECH FORM CHG CHEMICALS: 069105 Alkyl* dimethyl benzyl ammonium chloride *(SO%C14, 00.2800% 

### ID#, 000777-00068 LYSOL COMPANY, 000777 HOUSEHOLD PRODUCT MANAGER' 31 VELMA PM TEAM REVIEWER, TRACY RECEIVED DATE, 03/01/00 BRAND PRE-MOISTENED TOUCH-UPS DISINFECTING CLEANI PRODUCTS DIVISION, RECKITT & 

### COLMAN INC NOBLE 703-308-6233 ROOM, CS1 6W18 LANTZ 703-308-6415 ROOM, CS1 6W5

DUE OUT DATE, 05/30/00


## * * * DATA PACKAGE INFORMATION 

## * * *

04/21/00 

## 7'/2'0/" a 

## .y//? /6 <J 

### DATE RET., / / *(SO%C14, 40%C12, 

### DATE, DATE, DATE, ADMIN DUE NEGOT

PROJ OUT 

### / / / / / LABEL, Y DATE 

### / / / 

### / / Y

### DATE IN



### \?/ 7 / o o 

## J /7 /0 0 

### <3/7/° a 

## C> f'6 /0-0 / / ASSIGNED TO



### DIV , AD BRAN, PSB SECT, CTT REVR , 

# fYJ.e.J CONTR, .,.. DP BARCODE, 263852 EXPEDITE' N DATE SENT' 03/07/00 CHEMICAL: 069105 Alkyl* dimethyl.benzyl ammonium chloride 

### DP TYPE' 001 CSF,



## * * * DATA REVIEW INSTRUCTIONS 

## * * * Registrant has submitted CSF with changes/corrections to alternate formula.


## * * * DATA PACKAGE EVALUATION 

## * * 

### * No evaluation is written for this data package



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

## * * * DP Be 

### BRANCH/SECTION DATE OUT DUE BACK INS CsF LABEL


# A+

I I 

# r.:A

### The registrant addressed the changes requested to the Alternate Formulation CSFs by the Agency in its February 22,2000 letter. The following documents were submitted and examined in the chemistry review ofthis submission: registrant's cover letter dated March 1,2000, formulator's Exemption Statement dated March 1,2000, four (4) Alternate Formulation CSFs dated March 1,2000 and product label dated June 17,1992. FINDINGS: l.All of the deficiencies notedin thepriorreview have been adequately addressed. 2.The requirements ofPRNotice S1-2 were satisfied. The nominal concentration ofthe active ingredient given in the four(4)Alternate Formulation CSFs agreed withthe percentage declared on the label. 3.Upper and lower certified limits for both the active and inert ingredients are acceptable. 4.All active" and inertingredients utilized cleared for use inpesticide formulations.
S.All otherelements ofthe CSF were acceptable. RECOMMENDATIONS: This submission which addressed the deficiencies noted in the February 22,2000 Agency letter, is accepted. 4/13/00 ATForm Approved. OMB No. 20, _-0060. Approval Expires 11-30-93 

# &EPA United States Environmental Protection Agency Washington, DC 20460 

### Formulator's Exemption Statement (40 CFR 152.851**App~cant's** Nama and Address Reckitt 

### & Colman Inc. 1655 Valley Road Wayne. New Jersey 07474 EPA File Symbol/Rogistration Number 777-68 Product Nama L 1 B d P . yso ran re-Molstened**~l~~~oom** Touch-Ups Disinfecting Cleaning Date of Confidential Statement of Formula (EPA Form 8570-41 March 1. 2000
As an authorized representative of the applicant for registration of the product identified above, I here certify that: (1) This product contains the following active ingredient{s): n-Alkyl (50%C14. 40%C12. 10%C16)**d~methyl** benzyl ammonium chloride (2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing, formulation or repackaging of another product which contains that active ingredient, which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled for at least each use for which my product is proposed to be labeled. (3) Indicate by checking (A) or (S) below which paragraph applies: (A) An accurate Confidential Statement of Formula (EPA Form 857().4J for the above identified product is attached to this statement. That formula statement indicate, by company name, registration number, and product name, the source of the activeInuredientls) listed in paragraph (1). OR D{S) The Confidential Statement of Formula (CSFJ (EPA Form 857()..4J referenced above and on file with the EPA is complete, current, and accurate and contans the information required on the current CSF.
(4) 

### PJlODlICI'!NGIIEDIENTSOUl1Cl!INFORMA'ltONIS

### 00l"1NCttli)JjD The following active ingredients in this product qualify for the formulator's exemption. '

Source

Yellow , Applicant copy 

# D.'

Hite - EPA copy Name and Title Active Ingredient Re istration Numbor

aturo

EPA Form B570-27 (Rev. 7-91) n-Alkyl (50%C14, 40%C12, lO%Cl dimethyl benzyl ammonium chlorMarch I, 2000 

### Document Processing Desk (AMEND) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 1921 Jefferson-Davis Highway Arlington, Virginia 22202-4501 

### PIIOOIlCl'fIoIilBEDII'.Nl501lIlCE1NPORMAJ'IONISNOT INCLUDIlD Attn: Velma Noble PM-31



### RE: Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes EPA Registration Number.777-68 Response to EPA Letter Dated February 22, 2000 ,', 

### Dear Velma: This submission is in response to the EPA letter dated February 22, 2000. I have made the following changes/corrections to the alternate fomiulas 656-130, 656-131, 656-132, and 656-133: 1) 2) 

### 3) The certified limits for 656-132 and 656-133 havebeen corrected to and are now consistent 

### with the certified limits of656-130 and 656-131. 

### 4) I have revisedthe Formulator's Exemption Form to reflect all the sources ofthe active ingredient. 

### 5) We have changed the ProductName on the CSF's to reflect the name indicted on the original registration: " Lysol Brand Pre-MoistenedBathroom Touch-Ups Disinfecting Cleaning Wipes." I thankyou for bringing these corrections/changes to our attention.

'ncerely,
ruce ao ella Sr. Regulatory Affairs Specialist

RECKITT & COLMAN INC. ·1800 Valley Road, P.O. Box 942 Wayne, New Jersey· 07474-0942· (973) 633·3600· Fax (973} 633-3633

### February 2, 2000 Document Processing Desk 

### (Non-Notification) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency 

### Room 266A, Crystal Mali 2 1921 Jefferson-Davis Highway 

### Ariington, Virginia22202-450I Attn: VelmaNoble PM·31

RE: Lysol Brand PreMoistened Bathroon Touch-Ups Disinfecting Cleaning Wipes 

### EPA Registration Number 777-68 Non-Notification 

### labelchanges as perPR-Notice**98~10**


### DearVelma: 

### Reckitt& 

### Colman Inc. hasmade somenon-notification corrections/changes to themaster label for the above product and we are confirming those changes 

### withEPA. Below is an explanation ofwhat the changes consist of: 1) On page one (1) 

### ofthe master label we have added towelette quantities of(25) 

### and (35). We have added (Economy Size) (Bonus Size) (Citrus) (Summer Fresh) (Spring Waterfall) and (Country). We have put inbrackets the phrase (anywhere you travel) to allow us the option ofusing that phrase. We have added the phrase 

### (Resealable Pouch Inside). 2) Onpage two (2) we have bracketed the phrase (clean and) the words (disinfect) (toilet) (seats) and the phrase (and other) in the first sentence to allow for flexibility 

### withmarketing language. We removed references to Canister only and have bracketed (cleans surfaces and). Having Canister is inconsistent with how this product is marketed and bracketing (cleans surfaces and) allows for flexibility 

### withmarketing language. 

### 3) On page three (3) we have bracketed the words (clean) (and) (disinfect) (you) (travel) (public) (place) (facility) in the first paragraph. We have bracketed (fast) (convenient) (clean) (and) (disinfect) and (sanitize) in the second paragraph. We have bracketed (clean) (and) (disinfect) (sanitize) in the sentence after the second paragraph. 

# c?q

RECKIIT& COLMAN INC. • 1800 Valley Road, P.O. Box 942 Wayne, New Jersey •.07474.0942· (973) 633-3600· Fax (973) 633·36334) In the sentence "Forgeneral cleaning anddisinfection (sanitizing) hard nonporous surfaces." We have bracketed the words (cleaning) (and) (disinfecting). 5) We removed "Canister Only" from the lastparagraph. 

### 6) In the last paragraph we bracketed the words (convenient) (clean) (and), the phrase (is treated with a special cleaner that actually), the words (disinfecting) 

### (sanitizing) (use) (cleaning) (disinfecting) and the phrase (with this product). This again will give us flexibility with wording. 

### 7) On page four (4) we have removed the "Cardster Only" and "Pouch Only" and have bracketedthe words (Flush) (Toss), the phrase (Flush dirty wipe away). We added the phrase (Do Not FlushDown Toilet) and havebracketed the (hospital type) phrase in the last paragraph. 8) On page five (5) we removed the "Canister Only" and the first Storage And Disposal statement as 

### it is redundant with the Storage andDisposal statement in the sectionfor "Canister Only" The remaining pages have no changes made to them. Since the changes areconsistent 

### with Non-Notification changes outlined inPR-Notice 98-10 this registration action is being submitted as a modification to existing 

### label language. In support

### ofthis registration submission please find the following.
1) Application forPesticide Registration

### Form8570-1, OPP Identification Number 

### 252966. 2) Six (6) copies 

### ofthe revised master label, one 

### (1) copy with changes/corrections 

### highlighted. 3) Copy ofthe Accepted EPA Stamped label dated June 17, 1992.
Ifthere is any other

### information that EPA needs to expedite this submission, please feel free to contact me at 973-686-7391. I thankyou for taking care

### ofthis registration action.



### . Iitncerely,

### p~

# ~~ella Sr. Regulatory Affairs Specialist



### ,,' ,py PP py (ongm ) FO/n! Approved, OMS No. 2070-0060, Approval expues

A Fonn 8570 1 (Rev. 8 94) PrevIous editions are obso Please readinslructions on reverse before complell,.", form. 0531 98



### - 

## - 

# EPA United States 

# o Registration opp Identifier Number 

# 0 Environmental Protection Agency 

# o Amendment 

# 252966 Washington, DC 20460 

### ISJ Other Application for Pesticide Section I 1. CompanytProduct Number 2. EPAProduct Manager 3. Proposed Classification 777-68 Velma Noble 4. Company/Product (Name) PM' 

### [8J None 

# o Restricted Lysol Brand Pre-Moistened Bathroom Touch
- 31 Ups Disinfecting Cleaning Wipes 5. NameandAddress of Applicant(Inetude liP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) Reckitt & Colman Inc. (b)(l), my product is similar or identical in composition and labeling 1655 Valley Road to: Wayne, NJ 07474 EPA Reg. No. 

# o Checkifthis is a new address Product Name



## - Section -II 

## D Amendment- Explainbelow. 

## D Finalprinted labelsin response to Agency letterdated 

## D Resubmlsston in response to Agencyletterdated 

## D "MeToo· Application 

# Ei Notiflcanon
- Explainbelow. 

## [Xi Other- Explainbelow Explanation: Use additional page(s) if necessary. (For Section I and Section II.) Non
- Notification label changes/corrections as per Pfc-Notlce 98-10



### - See enclosed product labels, (one label with changes/corrections highlighted) Section
- III 1. Material This ProductWin Be Packaged In: Child-Resistant Packaging UnitPackaging WaterSoluble Packaging 2. Type of Container 

## D**Yes~** DYes DYes 

## D Metal 

### (8J No 

### (8J No 

### (8J No 

## l:8J Plastic It"Yes" No.per If "Yes" No. per 

# o Glass *Certification must Unit Packaging wgl container Package wgt. container 

## l:8J Paper be submitted 

## D Other(Specifiy) 3. t.ocenon ofNet Contents mrormanon 4. Size(s) Retail Container 5. Location of Label Directions 

### (8] Label 

# o Container 10,25,30,35,40 

### (8] On Label Pre-Moistened Towelettes 

## D On labeling accompanying product (7" X 8") (Pouch) 6. Mannerin Which LabelisAffixedto Product 

### D Lithograp'l 

### lEI Other X Printed on package 

### D Paperglued Pre-Printed plasticwraprpre-printed Cardboard box 

### D Stenciled Section -IV 1. ConlactPoint (Complete itemsdirectly below foridentification ofindividual10be conlacted, ifnecessary, 10process this application) Name Title Telephone No. (IncludeArea Bruce Paolella Senior Regulatory Affairs Specialist Code) 97J·686·739 i Certification 6. Da-e Application I certifythatthe statements I havemadeon thisform andall attachments thereto aretrue, accurate andcomplete. I Received acknowledge that anyknowingly falseor misleading statement maybepunishable byfine or imprisonment or both (Stamped) underapplicable law.

# 2~.z:

# j{,~ 

# D.Ofl 3. Title



### • Senior Regulatory Affairs Specialist 

# 3/ 4. ped Name 5. Date Bruce Paolella February 2, 2000 EP 

# - - .. lete whne- EPA File Co .. al Yellow-A licant Cot Revi ever 10 Submission No. Data Package No.

Action ecce**CCCi~.(;** 2Cf<'1 f':R APPUCAT!e.t'S feR**?.ECrS7:'""<ATIO'l/~** r i ie SY"""I/Req. NO. 

# 111-/P? '" 

# 12L

IE!Prop<:lsed Classification: IJOI rir.al Classificac.ion: / -' (2) Unconditional 

### / I<C) Certification ((·.\J!t c., / /(S) Service f!er;son / / (R) Non-r:esidem:.ial Use ()'ly 

### !ISI Child-resistant 

# '- ?aekar;l in; 

### 1201 Registration Type: ':./ (il ConditiO("lal 

### 1'51 !1"It.rastate Call-in / / (Y) Yes I I IN) No



### II (Rl Rest.riceed / / (G)**~neral** / I (Rl Restricted

" I (Nl Not Classified 

## ", i 

# 'I
-" ':-.; J 

## '-t
. (;(, 1401 Date Received by



# 1 t1,;.(1 t',q

# Iz? 

# 10 

# I

... 1'0 DA.X YR [801 Hoethcd of Support: I I III Ci**t~"-l.l** II (6) OJner Sutmiss ion / / I,) Hot.**A.pp~** i.ca.ole 

### /1 (7 ) Toeal Sutmission 

### L.! IS) Hot Sutrn.it ted / / IS) 

### Selective Kethod
Revieowet"S Req'I.lested: 

### CH EF 

### PL DE8 SDEa 78 

# I \ 

# ! I 

# , I • 

# i ! • 1 I 

# i

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# , 

# 1--1---1 :------1,----\



# • E::a

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### 4 2000 _"0 2At \::;, EFGS ---'--

..........

# --------.3;(., 11151 fIlW- 

### ",".;on.e/I) AC'I1CN Cede 

### ,y. 75-0l\'t R£SP:l-Ise CO£: CArt: L/( 'tl res- / j(NI NoUNITEO ST ES ENVIRONMENTAL PROTECTION A' ICV



### MAY 0 4 1000 Reckitt & Colman, Inc. 1655 Valley Road Wayne, NJ 07474

ATTENTION: BrucePaolella 

### SUBJECT: Lysol® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting CleaningWipes EPARegistration Number 777-68 YourNon-Notification Dated: February 2, 2000 EPAReceived Date: February4,2000

This is to acknowledge that the Agency is 

### in receipt ofthe changes which you have specified be added-to your labeL Afterreviewing this application, it has been determined that these changes do not comply with non-notification as perPRNotice 98-10. These label changes must be resubmittedto the Agency as an amendment. Included in the changes on yourlabel are modifications to place parenthesis around the words "disinfect" and "disinfecting." The PR Notice specifies that only claims for non-pesticidal effectiveness may be modifiedby.non-notification. These are pesticidal claims. In addition the Agency is unable to verify thatthe scents listed on your label (Citrus, SummerFresh, Spring Waterfall, and Country) are actually used in a formulation which has been accepted for this product. Identify to the Agency which scents are associated with which fragrances on an accepted Confidential Statement ofFormula.

COHCURRI!NaS

## ::::~**.1_~tg~·7** 

# '
..-.'

_ .,.**-...~**

# .., . 

# DATE
-

# 3-**~."".: ~.............**  

# ·

__**···~~;;:I~~·::~:·:~::** EPAForm (1190) Prbskdm 1W:ycltd**Pa~r**UNITED ST ':S ENVIRONMENTAL PROTECTION At iCY

Yourreferences to flush or toss the product and then the reference "Do Not FlushDown Toilet" are not in agreement. Explain to the Agency your intentions in using these contradicting phrases. Are there certain conditions underwhich the product should not be flushed? Should you have any questions concerning this letter, please contact TracyLantz at (703) 308-6415.

Sincerely,

Velma Noble ProductManager (31) Regulatory ManagementBranchI Antimicrobials Division (751OC)

7510C:T.Lantz:5/3/00:777-68b

EPAForm1320-1A(1190) • COKCURR!!HCl\:S SYMBOL. 

# . .



# ........•.•..•.... .......

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# ...............

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# . ......................

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# ........... 

# ....... ........._ 

# ...... SURNAMe

. 

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# ................. .................. 

# ..........•.......

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# -.................. ..•....•.•........ DATE



### .
. . OFFICIAL FILE COPY

## NOTE TO THE JACKET 777-68 

## 5/3/00 The following are concerns/commenton the text ofthe non-notification submitted for this product on 2/2/00. I should use this info as a guide when they come in as a label amendment. JohnNewland and Michele Wingfield felt that based on the condition ofthe current stamped label and the fact that this did not qualify as a non-notification it should be turned down and they should submit as an amendment. 1. On page one you may add the towelette quantities of(25) and (35) as well as the size (7" x 8"). You may also add (Economy Size), (Bonus Size), (Travel Size), and (pack). You may 

### alsoadd (ResealablePouchInside). Youmay modify

### thetwo sentences asfollows: "The quick and easy way to (clean and) disinfect (sanitize)" 

### "And other hard surfaces (anywhere you travel)." ASKEMILY

### Joh~ 

## .. 

# "",C:J.lI.f**~e(.\ a~**  

## 0.14.- I-yd 

# S.,.-lk.s**~~.-..\-** 2. Onpagetwo youmay includeinparenthesis onlythefollowing information inthefirst and**"J~.** 

### second statement asfollows: "Readyto use.convenient; thequick and easywayto (clean and) disinfect (sanitize) toilet seats (and otlterHJard surfaces." ASKEMILY "The quick, easy way to (clean surfaces and) kill (household) germs." 

### YQU may remove 

### thelanguage referring to canisters. 3. 

### On pagethreeyou mayincludeinparenthesis onlythefollowing information inthefirst setof statements as follows:

. "The fast convenient way to (clean) (and) disinfect (sanitize) hard surfaces

....l""Irere 

# tl::M.t (you) (travel)." ASK EMILY

### w~~IJ i'#\ 

### "Usethem onbathroom surfaces, toilet seatsandtelephones inmalls, restaurants, gas 

### all6U1 stations, airports, rest stops, ""y (public) (piIme) (facility) where germs or bacteria may be of**~S,** concern." ASK EMILY

## ~_------------/ 

## '- 4. Thefollowing changes to thelanguage section on pagethree are acceptable: ''The (fast) (convenient) way to (clean) (and) disinfect (sanitize) hard surfaces." "New" 

### Lysol® BrandPre-MoistenedBathroom Touch-Ups Disinfecting CleaningWipes 

### aretheconvenient wayto (clean) (and) disinfect (sanitize) hard surfaces." "For general (cleaning) (and) disinfecting (sanitizing) hard nonporous surfaces." "New* Lysol® Brand Pre-Moistened Bathroom Touch-UpsDisinfecting CleaningWipes are the(convenient) wayto (clean) (and) disinfect (sanitize) yourhousehold surfaces."

### "Each pre-moistened disposable wipe (is treated with a special cleaner that actually) killsgenus..." ASK EMILY 

### "Effective disinfecting (sanitizing) has neverbeenfaster oreasier." "Unplug small electrical appliances before (use) (cleaning) disinfecting (with this product.)" 

### 5. Onpagefour youmay deletethephrases "Canister Only" and "Pouch Only." Youmay also put parenthesis aroundthephase (hospital type). 6. On page five you may delete the phrase "Canister Only." 

### Youare required to submit an amendment and updated label to add thefollowing changes to thelabel as thesechanges arenotpermitted asnon-notifications. These changes willbe reviewed 

### asand amendment and comments to thelabel maybenecessary. 1. 

### TheAgencyisunabletoverifythat thescents listed onyour label (Citrus, SummerFresh, Spring Waterfall, and Country) are actually used in a formulation which has been accepted for this 

### product. Identifyto the Agencywhich scents areassociated with which fragrances on anaccepted Confidential Statement ofFormula. 2. 

### Only non-pesticidal claims maybemodified bynon-notification. Allreferencesto placingthe words disinfect and disinfectinginparenthesis mustbemadebyamendment. 3. Your label may list(toilet seats) in parenthesis, but not (toilet) and (seat). A unqualified toilet 

### isconsidered theentire interior ofthe 

### bowland your label does notprovide directions foruse for this surface. 4. 

### Your referencesto flush or toss theproductand thenthereference "DoNotFlushDown Toilet" arenot inagreement. Explainto theAgencyyourintentions inusing these contradicting phrases.



# j

# Tra~tz Team31 777-68n2Box (Pouch) (Canister) Label 

### 777-68 (Front Label) New

## * Lysol® Brand Pre-Moistened Bathroom 

### Touch-Ups Disinfecting Cleaning Wipes 

### CONTENTS 16 Individually Wrapped Pre-Moistened Towelettes 

### (8" x 

### 5 %") (Box) 

### 20 (25) (35)Pre-Moistened Towelettes 

### (8" x 5 %") 

### (7" X 8") (Pouch) 25 (35) Pre-Moistened Towelettes (7 y," 

### x 10'') (Canister) Ready to Use 

### (Economy Size) (Bonus Size) (Travel Size) (Pack) (Citrus) (SummerFresh)(Spring Waterfall)(Country) (Scent) HOSPITALS NURSING HOMES CLINICS DENTAL OFFICES SCHOOLS VETERINARY OFFICES BOWLING ALLEYS HOTELS RESTAURANTS DAY CARE CENTERS PHYSICIAN OFFICES HEALTH CLUBS AMBULANCES KENNELS AIRPORTS MALLS GAS STATIONS PUBLIC REST ROOMS PUBLIC TELEPHONES DIAPER CHANGING COUNTERS

The quick and easy way to (clean and) disinfect (sanitize) Toilet Seats Kitchen, Bathroom Laundry Room 

### Walls, Floors Diaper 

### Changing Counters 

### Table Tops Toilets, Sinks Showers, Tubs Tile, Enamel Porcelain Garbage Cans Diaper Pails Counter Tops Nursery Telephones Cabinets Storage & Pet Areas High Chairs

And other hardsurfaces (anywhere you travel).

• Quick

• Convenient • Portable *Will only be used for 6 months from date 

### ofintroduction(Resealable Pouch Inside) 

# 37Box (Pouch) (Canister) Label 777-68 (Front Label Cont.) 

## ALTERNATELANGUAGE Ready to use, convenient; the quick and easy way to (clean and) (disinfect) (sanitize) (toilet) (seats) (and other) hard surfaces.

Cleans Disinfects Sanitizes Hard Surfaces The quick, easy way to (clean surfaces and) kill (household) germs.

ACTIVEINGREDIENT: Alkyl (50% CI4 40% C 12 10% C 12 ) Dimethyl Benzyl Ammonium Chlorides INERT INGREDIENTS TOTAL 

### 0.28% 99.72% 100.00% Keep OutOfReach OfChildren CAUTION: See Panel for additional Precautionary Statements Does not include weight of

### dry wipe EPA Reg. No. 777-68 EPAEst. No. 777-IL-I, 777-NJ-2, 052631-NJ-00I (See Bottom)

2Box (Pouch) (Canister) Label 777-68 (BACK)
New* Lysol Brand Pre-MoistenedBathroom Touch-Ups Disinfecting Cleaning Wipes (Travel Size)

The fast convenient way to (clean) (and) (disinfect) (sanitize) hard surfaces anywhere (you) (travel). Use them on bathroom surfaces, toilet seats and telephones in malls, restaurants, gas stations, airports, rest stops, any (public) (place) (facility) where germs or bacteriamay 

### be ofconcern.



### ALTERNATELANGUAGE

The (fast) (convenient) way to (clean) (and) (disinfect) (sanitize) hard surfaces. Use them in toilet areas, under sinks, sick rooms, showers, bath tubs, patient chairs, examinationtables, garbage pails, operatories, stretchers, laboratories, cuspidors, door handles, wheel chairs, counters, and other places where germs or bacterial may be a concern. New* Lysol® Brand Pre-Moistened BathroomTouch-Ups Disinfecting Cleaning Wipes are the convenient way to (clean) (and) (disinfect) (sanitize) hard surfaces.

For general (cleaning) (and) (disinfecting) (sanitizing) hard nonporous surfaces. New* Lysol ® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes are the (convenient) way to (clean) (and) disinfect (sanitize) your household surfaces. Eachpre-moistened disposable wipe (is treated with a special cleanerthat actually) kills germs - even the germs that cause odors

- wherever you use it. No bottles, no sponges, no mess. Effective (disinfecting) (sanitizing) has never been faster or easier. Unplug small electrical appliances before (use) (cleaning) (disinfecting) (with this product). Not recommended for polished or bare wood surfaces. *Will only be used for 6 months from date ofintroduction.

3Box (Pouch) (Canister) Label 777-68 (BACK CONT.) Directions for Use: It is aviolation offederal law to use this product in a manner inconsistentwith its labeling. TO (CLEAN) (AND) SANITIZE HARD SURFACES (INCLUDING TOILET SEATS): Use a fresh towelette to wipe surface. (Flush) or (Toss) dirty wipe away. Allow surface to remain wetfor 30 seconds. To sanitize heavily soiled surfaces, repeat with a clean towelette. Not intended for personal hygiene. TO (CLEAN) (AND) DISINFECT TOILET SEAT: Use a fresh towelette to wipe toilet seat. (Flush dirty wipe away). Allow surface to remain wet for 10 minutes. To disinfect heavily soiled surfaces, repeat with a clean towelette. TO (CLEAN)(AND) DISINFECT OTHERBATHROOM SURFACES: Use a fresh towelette according to directions above. (Flush) or (Toss) dirty wipe away. (Do NotFlush Down Toilet)

Pull up tab and removed large cover. Insert triangular loop through slits in cover. Thread first sheet in centerofroll through loop. Replace cover. Pull loop back through opening. Pull each sheet up and slightly to the side. Always snap lid securely shut between uses to prevent moisture loss.
Peel backthe front label slowly. Remove towelette as needed. Reseal pouch by firmly running thumb over the label. Lysoi ® Brand Pre-Moistened Bathroom Touch- Ups Disinfecting Cleaning Wipes meets efficacy standards for (hospital type) disinfectant (sanitizing) wipe. Kills Influenza A2 (Japan) and herpes Simplex Type I viruses and Streptococcus faecalis germs. Inhibits mold and mildew in damp and musty places. Kills Human Immunodeficiency Virus Type I (HIV-I) (AIDS virus) on precleaned environmental surfaces/objects previously soiled with blood/body fluids in health

4Box (Pouch) (Canister) Label 777-68 (Back Cont.)

care settings or other settings in which there is an expected likelihood ofsoiling of inanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission ofhuman immunodeficiency virus type I (HIV-I) (associatedwith AIDS). Special instructions for Cleaning and DecontaminationAgainst HIV -1 of Surfaces/Objects Soiled with BloodIBody Fluids. Personal Protection: Whenhandling items soiled with blood or body fluids, use disposable latex gloves, gowns, masks or eye coverings. Cleaning Procedures: Thoroughly clean blood and otherbody fluids from surfaces and objects with a wet towelette. Use a second wet towelette to disinfect. ContactTime: Allow to stand 10minutes. Disposal ofInfectious materials: Blood and other body fluids should be autoclaved and disposed ofaccording to local regulations for infectious waste disposal. Precautionary Statements: HAZARDS TO HUMANS AND DOMESTIC ANIMALS Caution: May cause eye irritation. Avoid contactwith eyes. Wash hands after use. Statement ofPractical Treatment (FirstAid): In case ofeye contact, IMMEDIATELY flush eyes thoroughly with water, remove any contact lens, and continue to flush eyes with plenty ofwater for at least .15 minutes. Call physician ifirritation persists.

5Box (Pouch) (Canister) Label 777-68 

### (Back Cant.)
STORAGE AND DISPOSAL Storage: Store in original container in areas inaccessible to small children. Store 

### (canister) (box) (pouch) in a cool place. Disposal: Do not reuse empty container. Wrap and put in trash 

### Distributed By: Reckitt & 

### Colman 1655 Valley Road Wayne, NewJersey 07474

6Packet Label 

### 777-68 (Front) Lysol 

### ® BrandPre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes



### ACTIVEINGREDIENT: Alkyl 

### (50% C14 

### 40% C12 10% C12) Dimethyl Benzyl Ammonimn Chlorides INERTINGREDIENTS TOTAL 

### 0.28% 99.72% 100.00% Keep Out OfReach OfChildreu CAUTION: See Panel for additional Precautionary Statements

Does not include weight ofdrywipe 

### (Back) Lysol ® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes See outer container for additional precautions and directions for use. 

### CONTAINER DISPOSAL: Discard empty envelope in trash EPA Reg. No. 777-68 EPAEst. No. 52631-NJ-001

Net Contents: One Towelette

Reckitt & Colman 

### 1655 Valley Road Wayne, New Jersey 07474

7UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 

# JUN 171992

L&F Products 225 

### summit Avenue 

### Montvale, NJ 07645 Attn: Lysol Brand PreMoistened Bathroom touch-ups Disinfecting Cleaning Wipes 

### EPA Registration No. 777-68 Amendment dated December 12, 1991 The labeling referred to above, submitted in connection with 

### registration under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, for the addition of "Highchairs, Table Tops and counter TOpSIl to the use directions, is acceptable. A stamped copy of the labeling is enclosed for your records. 

### If 

### you have any questions concerning this letter, please contact Martha DeLaney at (703) 305-6982.

Enclosure Sincerely, 

# /

J:::.'fh.(}nvLH-. 

# Aroduct Manager 31 Antimicrobial Program Registration Division Branch H7505C



# '\81

# ij~U%~~~~j @ Printed on RecycledPaperI r**~ooro:s ~REST/llJRl!NIS**  ThY CARE CENI'ERS**~FllYSICIAN** OFnCES 

## ---HEA:I.:m CilJBS '1Il1EmANCES '-KENNELS New* IJfSOU' Brar<i 1're-'M:>istened Bathroan Toudl-lJps 

### Disinfeetirq cleanil'g 

### wipes
Ready 

### to Use Travel 

### Size (Pack) 

# crnroos 16 IlUivicll.la1ly Wraj;ped 

### Pren:>i.stened**~ettes** (8" X 5 3/4") (Box) 

### or 20 Pre-tloistened

### ~etteses_--:-.:;-:;:;~-;:;Pn1 (8" X 5 3/:;) <>=hl

... 

# Ace E PTE D 25 Pre-tloistened 

### wipes

.. 

# 11 

# lfjfj'!. (7 1/2" X 10") (canister)

. 

# J

# tm-

'= tWILLS 

### '-GAS S'l1c.'1'J:CNS

RJ"BL!C== FIlBLICTErZm:m:S DIAPER CHANGING

# ==
The 

### qui.ck an::! 

### e=y 

### way 

### to clean an::! 

### disinfect (sanitize) 

### Toilets I 

### sinks Sho,.;oers, Ttios 

### Tile, Enamel, Porcelain Garbage 

## cans, DiaJ:e,r Pails Nursery 

### Tele,hones 

### cabinets storage & Pet 

## rc-ees High Chairs Table Tops Counter Tops ani 

### other hard 

### surfaces anywhere you travel Toilet Seats Ki'tch

### en, Eo.th:i:'coms laundry Rccm 

### Walls,Floors Diaper ClJarging Counters

Q.llck • 

### =enient • Portable



### *Will only be used 

### for 6 nonths fran date 

### of intro:luction./PX lPOU::!l) IC1JlISTllRI UBEL 

### J'lP!l' 

### lam.I

!leady 

### 'to 

### use, ccrrvenierrtr the 

### quick erd eJ>S";/
....

### y 'to 

### cl..." erd 

### disinfect (sanitize) 'toilet 

### seats erd other hard 

### surfaces. 

# ACCEPTED 

# JUN 171991 .'



### The quick, 

### easy vay 'to 

### clean surfaces erd kill (hcusehold) gems Canister Only 

### Cleans 

### Disinfects 

### (sanitizes) lIaril 

### surfaces Under the Fedoral Insectlctue. Fung;dde. and**P.<:l6cn:id~,:,** P.el, (Ill amended, for r

## t.::'**~::.tiCldO** ,7 raQ';£ler<:>d under / / 

### /_60 EPA R,,'l. No.

ACI'IVE INo..-=J:ENJ:: Alkyl (50: CH' 40% C, 2' 10% 

# c,.> Direthyl =1 A':r;onIQrn O1lorIdes 

### INERT mGREDImrs: 

## =.. 0.2S% 99.721 100.00% ==OFRFACH OF CHII.mEN 

### =00: See 

### back panel for 

### additional precautiCllllUY 

### statenents. Does 

### not inclu1e 

### weight of d:l:y 

### wipe. EPA:Reg. No. 777-£8 EPA Est. No. 777-II.-l, ro-21 52531-lU-D01, 5935S-SC-OOl, 41925-WI (See Eottan)-, ) 

# ACCEPTED JUN 171992 Undo: tho Fed I f'un,.,.jeid era**rn~l!etiCj<l** .., " e, Qnd Roden"**.~** 0$ C11I1Cll1ded I tfi ,,"t.,£> Act,**Ulg~terod ~d~~** **·:.~r4:::,ticido** 

## '"'"

.... N.. / 

# 7/-G? Travel Size -3-



### Pre-M:>istened llathroan Twdl-lJps 

### Disinfect:.irq Cleanirq Wipes 'llle 

### fest c:mvenient 

### way 

### to clean an:l 

### disinfect (sanitize) ba%tl 

### surfaces anywhere you 

### travel. Use them al 

### bat!u:o:lll 

### surfaces, 

### toilet seats 

### an:l tel€fhor>es 

### in nalls, 

### restaurants, gas Iitatia'lS, lliIporl:s, :rest 

### stqs, a:Iri&Jbli9plaoe (facility) 

## .mere germs 

### or bacteria nay 

### be a <:x:>nce:m.

'llle 

### fest cenvenient way 

### to clean an:l 

### disinfect (sanitize) ba%tl 

### surfaces. Use them 

### in 

### toilet areas, under- 

### sinks, sic){ rcans, shocera, batll 

### 'b.lbs, 

### patient d1aixs, exandnatii.on tables, garbage pails, q;eratories, stretchers, laboratories, 

### cuspidors, deer harrlles, wheel 

### c:ha.i:rs, 

### co.mters, m:d other 

### places 'Where germs or bacteria nay be 

### a concern. 1IfM* 

### Lyscl'" Brarx:I Pre-Moistened llath:r= Twdl-lJps 

### Disinfecting Cleaning wipes 

### are the cenvenient way 

### to clean an:l 

### disinfect (sanitize) hard 

### surfaces.



### For general 

### cleaning an:l 

### disinfecting (sanitizing) hard OOl1};X)l"'O..lS 

### surfaces. Nffi,* qsol'" 

### Brarx:I 

### Pre-i'loistened llathrcan Twch-lJps 

### Disinfecting Cleaning Wipes 

### are the cenvenient way 

### to clean an:l 

### disinfect (sanitize) 

### your hc:usehc1d surfaces. Each 

### prenoistened, disj:osable wipe 

### is treated 

### with a special cleaner that actually 

### kills germs - even the 

### germs that 

### cause cxlors
- 

### ..me>:everycu 

### use 

### it. No bottles, ]X) 

### sp::m;es, no JreSS. 

### Effective disinfecting (sanitizing) has 

### never been 

### faster 

### or .. 

### easier. Unplug small 

### electrical**~iarces** 

### before 

### lu"':J

### ~~ Not rea:mnen:led 

### for polished or bare 

### 0'I:<:<i



## * Will 

### only be used 

### for 6 IrOnths 

### fran date 

### of introduotion.

## • !OX (fg1Q!1 (CNjISJ'ERl WE, 

### ll1\CK ro;m.l Directions for use: It is a violatia> of federal law 

### to use 

### this prt:duct 

# m a Il>'ll1l1"I' 

### in::onsi.stent 

### with its label.in;J. 

## eo etn.ll J.Nl) =ZE lOOlD!ltJRF7lCES 

### (=m:; 

## ro= SEA1'S): Use 

## a ft'esh tawelette 

### to wipe surface. :Flush 

### or ta3s dirty 

### wipe """'Y' All'" surface 

### to wet for 30 sa::c:n:ls. To 

### sanitize heavily salla:! surfaces, xepeat with 

## a clean**~ette.** !jot intended for personal hygiene. .- ::' 

## ro etn.ll J.Nl) msINFECr 

## ro= SE1l:l'. use 

### a fresh t<>o'elette 

### to wipe toilet 

### seat. :Flush 

### dirty wipe 

### a""'Y. All", =ace 

### to %eJII>in wet 

### for 10 

### mirnJtes. To 

### disinfect: beavily salla:! =aces repeat with a clem> t<>o'elette. 

## ro etn.ll »lD DISINFECr

# = 8ORF1lCES' Use 

## a fresh t<>o'elette 

## a=dinJ to di:rections el:ove. :Flush 

### or ta3s dirty 

### wipe """'Y.



# CCEPTED 

# JUN 171992 Pull 

### "P tab an:l 

### rem:JVe large 

## c:cver. Insert trilln;lllar 

### 1= through 

### slits :In exNer. 

### n>re3d fitst sheet :In center of roll throUgh 

### 1=. Replace exNer. 

### Pulll= back throUgh 

### cpen:lng. 

### PIlll each 

### sheet 

### "P an:l 

### slightl to the side. Always 

### snap 

### lid securely shut between

## uses~"",;;;:..------~ prevent moisture loss. canister only

Undor the Federal Inaectieida, Fur..gkhi", -:Inc! Flodcnli<:'icleAat,

. atolr>n<:!

..d, for di..,**p..,~tidd(t** •**gb~e~cd** Ulldet7?'l r V EPA ReII'. No. 

### r,**-~tJ** 

### , 

# Iffil back 

### the front label. sl",ly. Re:rove t<>o'elettes

needed, Reseal po.>ch by 

### finnly l:llnnin;r 

### thumb r:Ner**u~==~"-.£..L£..:..'::::...J** 

### label.. p".,ch 

### only 

### I1;sollll B:ran:l Pre-Moistened 

### Eathro::ln Tl:uch-tJps 

### Disinfectin;l Cleanirg Wipes TIEets 

### efficacy stan:Janls 

### for (hospital type) 

### disinfectant (sanitizin;l) wipe. }(ills Influenza 

### 1.2 

### (JaJ?"1ll an:l 

### Hgrpes 

### Sistplex 

## 'I1Pe 1 

### Vixuses an:l**~=** 

### faecalis germs. 

### Inhibits mold an:l 

### mildew 1Il 

## ilali'i5" afinmlSt:y-pIaBES. Kills !!= 

### !MmJnodeficien:::y Vixus 'IyPe 1 (IlIV-IL(AlrS Vixus) 

### an preclemla:l 

### environmental surfaces/ooject:s previrosly 

## sOiled with blocd,ll:xxly fluids 

### :In health 

### care settin;Js or other 

### settin;Js 

## m \oIhich there 

### is an e:<pecta:I 

### lil<elihood of 

### sailin;J of 

### inanilnate surfaces/ooject:s with blood or body 

### fluids, and 

### :In \oIhich the 

### surfaces/ oojects lil<ely to be 

### salla:! with blood or body 

### fluids 

### can be 

### associated with the 

### potential for transmission of human 

### .inmmcdeficien:::y vi= 

## 'I1Pe 1 (IlIV-l) 

### (associated with AlrS) • . 

### special 

### Instructions for Cleanirg an:l 

### DeconUminatian l\;ainst 1':':".,1 

### of surfacesfCbject:s salla:! with Blood,lBody 

### l'1uids. 

### fWsonal Protection:**~en** 

### han:llin;J items salla:! with blood or body 

### fluids 

### use clisposable latex glr:Nes, ge<ms, 1lIaSks 

### or eye 

### coverin;ls. Cleaning Procedures: 

### 'Ihorco.>ghly clean blood ani other body 

### fluid,; frc:rn

..**~aces** 

### ani 

### ti;ljects with a wet**~lette.** 

### Use a second wet to\;elette 

### to**disinfec=~.** Cbntact Time: All"" 

### to stan:l 10 

### minutes. piSjXlS!ll of Infectious ",,,,terials: Blood an:l 

### other body 

### fluids 

### should Ix! 

### autoclaved and 

### disposed of aceordin;l 

### to local regulations for**infecticu~** W3ste 

### clisp=l.

• i ('-' 

# f..-r .:

# -. " 

### •. 

### ) I ,

glX (FroCIIl (CANlSI'ERl 

### TAm. 

### m::K 

## ro:N1'.J 

## =malAAY== !lAZAl'l:6 

## ro Il\.1MANS

# = tx:M!STIC ANlM1lIS 

### caution: Y.ay cause eye irritation. Avoid cx:rrt:act with eyes. Was!> 

### hands after 

### use. OF H\IICl'loo, 

### ==n' In 

### case of eye contact, DrMEDIATEIJi 

### flush 

### eyes thol:'OOgllly with 

### water, renove any contact lens, an:! 

### continue 

### to flush 

### eyes with plenty of

# ""ter for a least 15 

### lninutes. call a l'hYsician if 

### irritation 

### persists.



# == AND DISrosAL 

### storage:**store·~** 

### package in 

### a cool, dry 

### place. Container Disposal: 

### Put 

### enpty box (pouch) 

### an:! 

### envelq:>es in trash 

### collection.

Canister 

### Only 

# == AND DISrosAL 

### Storage: Store 

### in original o::mtainer 

### in areas inaccessible 

### to 5I1Bll dUldren. 

### Store canister in 

### a cool place. Disp:>sal: D::> 

### net reuse enpty rontainer. Wrap 

### end 

### >'It in trash.
Y.anu!actured 

### by L & F Products Montvale, Ne'W 

### Jersey**0764~.** 

# ACCEPTED



# . JUt\ 17 1992

, •. >"_1 • 

# . • /



## • j'.J 

## PN:m'Ilm 

# rn::m =R SWlD ffiE-+OIS'l»lED**'Itt1Ql~ 1lIS~**  

### c:ID.l!Im lIIHS •



## Alk.i1 (5ot 

## 1:'14' 40t 

# CJ.2. lot 

# Ci.sl**~.nyl** 

### lle:'lZYl 

### 1ollm:rU\lIll Clllar:lJSos 

### . 0.2"

• 

### 1l:>es 

### l'lI>t**~u:Ia** 

### -....i<;ht of drj**~. =C1JrOF=OF~**  

### c:.>JmCV 

# fA 

# C C E PTE

# j)" 

# JUN 171992 Under tho Fed Fungields, Qnd'!IrQl**ln~~e.ticide.** 'Ir'!...""'P QIJ emended t R'it,nl1 c1de A<:!t,**regisle~o:i U~d~~**  t It pesticidll SPAn.g.No. 

## 77 (,9 ffiE-+OISTmI:D 

### LYSOLR&.rnD 'ItUOl-tlPS**I>IS~==**


## see 0Jter**<="~** 

## far a&:l.itjcnol 

### pncautiCN 

## am clinct.icr.s for use.

!:l'A**~.** 

### No. 777-68 " .' !:l'A 

### rst. No. 52631-NJ-00l

L 

### &F Products

. a: laMI •tl,lp'1**~e.lU** 

### 07545

•Re.vie... er 10

Action 

### ecce Data Package. No. Submission No. 

# FQPA

fde**s~.:x:::l/Req;** No. 

### me i**~~:; rc~**  f'2R A.P?LICATICNS fC·R ?,£CIS'i':'"""nO".ljN-l.ENO-iENI"S

# l11-te~?1 

# M

12Slpcop¢ucl. Classification: IJOI fir-.al ClassificatiO"l: I " (2) Unconditional !S 1 Intrastate. Call-in / / l't) Yes I I IN) No !201 Registration Type: /./ (1) Conditional 

### !lS 1 O'Iild-resistant Pack-agio; I IIC) Ce.nificacion**J-.'flv,h~** I liS) se rvrce Pecson I I IR) Non-resicient i al 

# C;c Use o,ly /'( 'I ' .' / IN) Nct-Aopl

### teaete t-' 

# i.'?f

/ / (R) Restricted / / (G) General / / (R) Restricted .' / (N) Not Classified.

180 

### I Kethcd of**Sl,J~C1::** I I Il) Cite-All II IS) 

### o-re r Sub:nission / I I') Not A.ppi i cable I I (7) Total Sutmission / I IS) Not Sutmitted I I I B) Sele.ctive Method
Reviewl!cs Requested: 

### CH EF PL' DEB**~DEB** 

# I 

# I I , I 

# , • 

# , I 

# ,
• I 

# I , [



# -- • 

# I I

# I

7B



# • EEB**7S-~Y** RESPONSe CUt**~TE:** / /(Y) Yes EFGB 

### IllSI ruW. Aene< geaccose

# II Cede _..!...!._ I /(N) No**~B2** 

### 1000 

# 5/UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



### Household Products Division Reckitt

### & Colman Inc. 1655 ValleyRoad Wayne, NJ 07474 ATTENTION: Bruce Paolella FEB 11 1GfiB



### SUBJECT: 

### Lysol®Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes EPARegistration Number 777-68 

### Amendment forAlternateFormulations YourAmendment Dated: November 22, 1999 EPAReceived Date: November24, 1999



### This is to acknowledge receipt 

### of youramendment to add alternate formulations forthis product. TheConfidential Statements ofFonnula(CSFs) for theAlternateFormulations (Formulas #656-130, 656-131, 656-132, and 656-133) dated 11/19/99 has been reviewed and it 

### has been determined that this amendment isunacceptable dueto thereasons listed below. 1)Three ofthe submitted formulations listReg:

## ~-.s asource 

### ofactiveingredient. This source contains four activeingredients which are not**presen;~rrnulation.** 

### Itappearsthat this is atypographical error since oneformulation lists**Reg.~_~hich** 

### is anappropriate

. sourcefor yourproduct. CorrecttheReg. #'s associated 

### withthis source.

'.

OFFICIAL.FI1.E COPYUNITED STATES ENVIRONMENTAL PROTECTION AGENCY



# _ .. 

### 3) The certified limits are incorrect for th informulations 656-132 and 656-133. The limits should be revised to agree with t e certi ed limits table according to 40 CFR 158.175 (b). It appears that these are typographical errors since all limits (upper and lower for product added as well as nominals) are correct fo In formulations 656-130 and 656-131. 4) This file has been reviewed and it has been determined that the only Formulator's Exemption form**,~8/86** 

### and it does n.Q! 

### list allofyour sources ofactive ingredients. Specifically,**Reg.~s** 

### not listed onthis form. Submit an updated Formulator's Exemption which lists all sources ofactive ingredients (in the Basic and AlternateFormulations) which you 'are 

### currently**~ulate** 

### this product including the Reg.# ofany new source you may receive from 5) Our records indicate that the name ofthis product is "Lysol® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes." Revise your CSFs to agree with this name. Ifit is yourintention to changethe name ofrecord for this product, you may do so by submitting a notification to the Agency. Should you have any questions concerning this letter, please contact Tracy Lantz at (703) 308-6415. 

### INI!IlT

### INGIIlDII!NI'INI'OIIMATIONISNO!'IN<J.UDED



### Sincerely,

Velma Noble Product Manager (31) Regulatory ManagementBranchI Antimicrobials Division (751OC)

751OC:TLantz:2/22/00:777-68a 

# 53



# - CONCURRENCES SYMBOL.**:SU~.H~E'** 

# -.-**~~**

# ..•...... ....•...........

# - "



# _ 

# ................•........." 

# .

. . • •.••• uu ••• u.u " ••••••

_ - •••••••••••••••••• 

# ......................

# ,.................. -**OFFICIA~.FIt.E** COpy

## NOTE TO THE JACKET 777-68 2122/00 

## On this date I discussed some concerns I had concerning these CSF's with our chemist Alex Traska. He agreed with the following and said I 

## should put this note to thejacket as a summarization ofour conversation. I. 

## It 

## appears tha ,was listed on three ofthe CSF's in error. One CSF does have a correct which is likely the source they intend to use. I will'

## ask the registrantto

## ~or;:ect this Reg. No. 2. 

## One listed source.

__

# ~includes~s an active ingredient and is a product which is no longer marketed

## b~ Alex says I 

## should tell the registrantthat this productis no longer on the active product list forl!llll!!lland 

## that they should

## contact~for an appropriate alternativesource. ' 

## 3.

# .Eormulations 656-133 and 656-132 include incorrect certified limits for Advise the registrant that the limits do not agree with the certified limits table and appear to be typographical errors.

. 4. Alex also brought me information regarding the inert agrance which is now cleared for use in pesticide formulations.

# j~~ Tracy Lantz Team 31 777-68nl

### Page is not included in this copy_ Pages through 

# :5-r; are not included this copy.

The material not included contains the following type of information: Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control**pr~cedures.**

# _-c~~ Identity of the source or product ingredients_ Sales or other commercial/financial information. A draft product label. The product confidential statement of formula. Information about a pending registration action. FIFRA registration data. The document is a duplicate of page(s) The'document is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your :r:equest.

### DP BARCODE, D261607 

## FQPA CASE, 008454 SUBMISSION, S572222 DATA PACKAGE RECORD BEAN SHEET 

### DATE, Page 

### 12/08/99 1 

### of 1


## * * * CASE/SUBMISSION INFORMATION 

### * * * CASE TYPE, CHEMICALS, REGISTRATION 069105 Alkyl* ACTION' 362 AmD-TECH FORM CHG AMEND dimethyl benzyl ammonium chloride *{50%C14, 

### 00.2800% ID#, 000777-00068 LYSOL COMPANY, 000777 HOUSEHOLD PRODUCT MANAGER, 31 VELMA PM TEAM REVIEWER' TRACY RECEIVED DATE, 11/24/99 BRAND PRE-MOISTENED TOUCH-UPS DISINFECTING CLEANI PRODUCTS DIVISION, RECKITT & 

### COLMAN INC NOBLE 703-308-6233 ROOM, CS1 6W18 LANTZ 703-308-6415 ROOM, CSl 6W5

DUE OUT DATE, 02/22/00



## * 

## * * DATA PACKAGE**~NFORMATION** 

## * * *

01/21/00 

### /**/2~/** 0.0 

### //J'/oc; DATE RET., / / *{50%C14, 40%C12, 

### DATE, DATE, DATE, ADMIN DUE NEGOT

PROJ OUT 

### / / / / / LABEL, Y DATE 

### / / / / / ASSIGNED TO

DIV , AD BRAN, PSB SECT, CTA{ REVR , f-!-', 

## '-eA CONTR: 

### DP BARCODE, 261607 EXPEDITE, N DATE SENT, 12/07/99 CHEMICAL: 069105 Alkyl* dimethy£ benzyl ammonium chloride 

### DP TYPE, 001CSF,



## * * * DATA REVIEW INSTRUCTIONS 

### * * * Registrant has submitted four alternate formulations for the 

### above registration. The CSF is included in the package.



## * * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * * DP BC BRANCH/SECTION DATE OUT DUE BACK INS CSF LABEL

,UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFJCEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


### SUBJECT: Product Chemistry Review of Lysol Brand Pre-moistened Bathroom Touch-ups Disinfecting CleaningWipes DP Barcode: D261607 Manufacturing-use [ ] Reg. No. or File Symbol: 777-68 End-use Product [X] ActiveIngredient Composition: Alkyl (50% C14,40% Cl2, 10% C16) dimethyl benzyl ammonium chlorides O.28%



### TO: FROM:

THRU:

THRU: Velma Noble PM 31 AlexTraska, Chemist Product Science Branch, CT Team Antimicrobials Division (751OC)

Karen P. Hicks, CT Team Leader Product Science Branch Antimicrobials Division (7510C) Michele E. Wingfield, Chief Product Science Branch Antimicrobials Division (7510 C) BACKGROUND: This application for amended registration, for the subject disinfecting wipes, was submitted by the registrant, Reckitt & 

### Colman.

# 59 In this application, the registrant wishes to amendthe CSF to include four Alternate Formulations which will be based on the use ofdifferent fragrances. The following documents were submitted and examined in the chemistry review ofthis submission: registrant's cover letter dated November 22,1999, application for amended registration dated November22,1999, Certification Statement for PR Notice 98-10, 656-130, 656-131, 656-132 and 656-133 Alternate Formulation Confidential Statements ofFormula datedNovember 19, 1999 and product label dated June 17, 1992. FINDINGS:

2.. ihas 

### not been cleared for use in pesticide formulations. Composition data from 'has not been received, at the time ofthis review, to expedite the clearance ofthis fragrance. 3.The requirements ofPRNotice 91-2 were satisfied. The nominal concentration ofthe active ingredient given in the four Alternate Formulation CSF agree with the percentage declared on the label. 4.Upperand lower certified limits forboth the active and inert ingredients are acceptable. 5.All otherelements ofthe CSF were acceptable. RECOMMENDATIONS: This application for amended registration, involving the three approved fragrances in LysoI Brand 

### Sanitizing Wipes, is accepted.

. The review and clearance ofthe composition for the

## ~agrance is still outstanding. Therefore, the alternate formulation utilizing this fragrance is not accepted. 1/28/00 ATNovember22, 1999

DocumentProcessing Desk (NOTIF) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 1921 Jefferson-Davis Highway Arlington, Virginia 22202-4501 Attn: Velma Nobel PM-31


### RE: LysoI Brand Sanitizing Wipes EPA Registration Number 777-68 Certification StatementperPk-Norlce 98-10
This notification is consistent 

### with the provisions of

### PR Notice 98-10 and EPA regulations at 40 CFR 152.46m and no otherchanges have been made to the labeling or the confidential statement offormula ofthis product. I understand that it is a violation of 18 U.S.c. Section 1001 to willfully make any false statements to EPA. I further understand thatIfthis notification is not consistentwith the terms of PRNotice 98-10 and 40 CFR 152.46, this productmay be in violation ofFIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 ofFIFRA.

# bf~ Sr. Regulatory Affairs Specialist



### " , 

# .... AECKITT & COLMAN INC.• 1800 Valley Road, P.O. Box 942 Wayne, New Jersey 07474-0942' (973) 633-3600· Fax (973) 633--3633 , " , ,

••••

### November22,1999 Document Processing Desk (AMEND) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 1921 Jefferson-Davis Highway Arlington, Virginia22202-4501 Attn: Velma Nobel


### RE: Lysol Brand SanitizingWipes EPA Registration Number 777-68 

### Amendment for Alternate formulations for Fragrance Change
Dear Ms. 

### Nobel: Reckitt & 

### Colman Inc. is submitting 

### 4 alternate formulations for the above registration. The only difference in formulations being the different associated fra ranees. I have asked 

## )0supply to EPA complete chemical compositionof the the agency should have chemical com osition ,informationfor all the other three fra 

### ranees'

__ In support I) EPA Application for Pesticide Registration 8570-1, OPP Identification Number 252961. 2) 

### Certification Statement as per PR-Notice**98~** 

### IO. 3) Confidential Statement ofFormula for formulations 656-130, 656-131, 656-132, and 656-133. Should the agency need any further information regarding this registration action, please feel free to contact me at 973-686-739L 

### I thank you for taking care ofthis submission. 21.neerely,

### p~

# 'fB?~ella Sr. Regulatory Affairs Specialist

AECKITT & COLMAN INC. o 1800 Valley Road, P.O. Box 942 Wayne, New Jersey: 07474-0942· (873) 633-3600 0 Fax (973) 633-3633FormApproved, OMS No.2070-0060, Approval expires

WhIte EPA File Copy (original. el c Appllcant Copy F nn 8570 1 (Rev.8 94) PrevIous ed tions are obsolete Ptease read instructions on reverse before clJIllpteting form. 053t98



### . .

Ill> 

# EPA United States 

# o Registration opp Identifier Number 

# 0 Environmental Protection Agency X Amendment 

## 252961 Washington, DC 20460 

# o Other Application for Pesticide
- Section I t. CompanylProduct Number 2. EPAProduct Manager 3. Proposed Classification 777·68 Velma Nobel 4. CompanylProduct (Name) PM' 

## C8J None 

## D Restricted Lysol Brand Sanitizing Wipes 31 5. NameandAddressofApplicant(Inctude ZtP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) Reckitt & Colman Inc. (b)(I), my product is similar oridentical in composition and labeling 1655 Valley Road to: Wayne, NJ 07474 EPA Reg. No. 

# n Checkifthis is a newaddress Product Name Section -II 

# o Amendment
- Explainbelow. 

### . 

# o Finalprinted labelsin response to Agency letterdaled 

# o Resubmlsston in response to Agencyletterdaled 

# o "MeToo' Application 

# n Ncnncencn - Explainbelow. oeer- Explain below ExplanatIon: Use additional page(s) if necessary. (For Section I and Section IL) Amendment for alternate formulas 656-130, 656-131, 656-132, and 656-133

Section -III t. Material This ProductWill BePackaged In:**~Id-Resistanl** Packaging Unit Packaging WalerSoluble Packaging 2. Type of Container 

# o Yes· 

## I3J Yes 

# o Yes 

# o Metal 

## I3J No 

## 0 No 

## I3J No 

## l8J Plastic If "Yes' No.per It"Yes' No.per 

# o Glass *Certification must Unit Packaging wgl container Package wgl container 

# o Paper 1.50z 4 be submitted 

# o Olher (specifiy) 3. location of Net contents Intormation 4. Size(s) Retailccntemer 5. location of label Directions 

# o label 

### [3j Container 8 11 x5 

### '.4" (8J On label 

# o On labelingaccompanying product 6. Ma.nner inWhich label isAffixed 10 Product 

# o lithograph I2Sl other _Printed on package 

# o Paperglued 

# o Slenciled Section-IV 1. conrect Point(Complete itemsdirectlybelow for identification ofindiVidualtobe contacted, ifnecessa/y, toprocess thIs apptication) -Name Title Telephone No. (Include Area Bruce Paolella Senior RegUlatory Affairs Specialist Code) 973·686·7391 Certification 6. cere Application I certifythat theetarements I havemadeon this form and anattachments niererc aretrue, accurate and complele. I Received acknowledge Ihatanyknowingly falseor misleading statemenl maybe punishable byfine orimprisonment or both**t~tamped)** underapplicable law. 2. Sig kJure

# p~ 

# Po I() 3. Title 

### r-, Senior Regulatory Affairs Specialist 4. Typed Name ,5. Date 

### t' " Bruce Paolella November 22, 1999 V;:';/, EPA 0 

### . . ; 

### . 

# , v- I w-Reviewer 10 

# FQPA Submission No. Data Package No.**CCCi~.c** rcF<-l fl::R AP?UCATICNS feR**P..£GI5"i7""'TI~!~** ftle Syr:-.:x>liRe<;'. No.

# 711
... to [ ?1 

# -.!!2L- Action ecce 110

### I ce scrrccor 

### U

....nerrl/ResU1:n.i'iOl",! only)



# . 1251PropoSfld Classification: 1301 rin.d ClassificatiOl"\: 15 

### I Intrastate Call-in / / (Y) Yes I I (N( No

, 

### ,**--.,.~** .. " , l' i-" 

## / /rc: Certificatloo / /(5) Service Per-see "? /

" ,<\- / / (R) Non-residential, Use ceLy .'t,JJj', (151 Child-resistant**packaqi~**

/ " (2) Unconditional

/ / (fl.) Restricted .' / (N) Not Classified / / (R) Restricted / / (G) c.net'al 1201 Registration 

### Type: 

### l. 

## I u: Conditional

1'i01 Date Received by 

# 101/1/1010 It?

... K) DA.X 'fR 1801 Hethc:d of Supp:rt: / / (ll Cite-All 

### /1 (6) C\.'rler Sutmission / / (4) Not**A.pp~icable** 

## /7 (7) Total Sutmission / / (5) Not Sutmitted 

### I / (8) Selective Het.hc:d nevieve es Requested: 

### CH EF 

### PL CEB 

# I I I I I , 

# i , , I 

# i I :-- , I RES?:l<SE =$E coot 

## CAr:: \ \ I I 

# I 

# I , I

73



# , EEB EFCB 

### IllSI 

## mw.**Respo~** 

### II" 

### I Respcnse 

### 'JAN 2.7 

## mno 

# b

# .3 'CITCN 

## Coo. ' I 

### -o ts« 'I.:;' 75-Ql..Y R£SfCl'/SE: COt: Dl.1"E: 

### LJIY>**Yo~** I I(N} NoUNITED STATES ENVIRONMENTAL PROTECTION AGENCY

Reckitt & Colman, Inc. 1655 Valley Road Wayne, NJ 07474 

## JAN 17 IUUU

ATTENTION: BrucePaolella SUBJECT: Lysol® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes EPARegistration Number 777-68 

### YourNotification 

### Dated: December 29,1999 EPA Received Date: December 30, 1999


### Thisis to acknowledge receipt ofyour

### notification toadd additional brand names forthe above referenced product. This application isacceptable. Theproposed alternate brand names "Lysol Brand Antibacterial Wipes," "Lysol 

### Brand Disinfecting Cleaning Wipes," and "LysolBrand Disinfecting Wipes" areacceptable and will be made part oftherecord forthis file. 

### Should youhave any questions concerning this letter, please contact TracyLantz at (703) 308-6415".

OFFICIAL.FILE COPY Velma Noble ProductManager (31) 

### RegulatoryManagement Branch

### T. Antimicrobials Division (751OC)

ePAForm 1320-1A(1J90) 

### 1, 10C:TLaol>: 1/:;'1100:111**~3** CONCURRENCES



### .

. SYMBOL. 

# "]/!;';;;" .

................

# - .................. 

## ..................... 

## .................... 

## .............., 

## ........ 

## ...

# _ .............. .....-..•...... SlJRNAME

# i 

# "I'aiffu" ................. .................... 

## .."

### ................ 

# ...............

# ...... ._

## ...........- ..................... ..................... DATE



### .
..)1

December29, 1999 DocumentProcessing Desk (NOTIF) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 

### 1921 Jefferson-Davis Highway Arlington, Virginia 22202-4501 Attn: VelmaNoble PM-3l


### RE: Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes EPA Registration Number 777-68 

### Notification for alternate brand names DearMs. Noble: Reckitt & ColmanInc. would like to submitthe following alternate brand names 

### for that above productregistration: Lysol Brand Antibacterial Wipes Lysol Brand Disinfecting Cleaning Wipes Lysol Brand Disinfecting Wipes In support ofthis registration action the following documentation is being submitted: 

### 1) Application for Pesticide Registration EPA Fonn 8570R

### 1, OPP Identification Number 252964. 2) Certification statement as per PR- Notice 98-10. Ifthere is any other informationthat is needed to complete this submission, please feel free to contactme at 973-686-7391. I thankyou for taking care ofthis notification.

# lL~P~**~'uce** Paolella Sr. Regulatory Affairs Specialist

RECKITT & COLMAN INC. '1800 Valley Road, P.O. Box 942 Wayne, New Jersey 07474-0942· (973) 633-3600· Fax (973) 633-3633December29, 1999

DocumentProcessing Desk (NOTIF) Office ofPesticide Programs (7504C) U.S. Environmental ProtectionAgency Room 266A, Crystal Mall 2 1921 Jefferson-Davis Highway Arlington, Virginia 22202-4501 Attn: Velma Noble PM-31


### RE: Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes 

### EPA Registration Number 777-68 Certification Statement perPR-Notice 98-10

This notification is consistent with the provisions ofPRNotice 98-10 and EPA regulations at 40 CFR 152.46m and no otherchanges have been made to the labeling or the confidential statementofformula ofthis product. I understand that 

### it is a violation of 18 U.S.c. Section 1001 to willfully make any false statements to EPA. I further understandthat Ifthis notification is not consistentwith the terms of PRNotice 98-10 and 40 CFR 152.46, this productmay be in violation ofFIFRA and 1 may be subject to enforcement action andpenalties under sections 12 and 14 ofFIFRA.

Sr. Regulatory Affairs Specialist



### , 

# .. " 

# .

•

### ••• RECKITT & COLMAN INC. ·1800 Valley Road. P.O. Box 942 Wayne, NewJersey 07474·0942' (973) 633-3800· Fax (973) 633-3633Pleasereadinslructions on reverse before com}j,elingfonn. 05-31·98 ...urm Approved. OMS No. 2070-0060, Approvalexpires



# &EPA United States 

### 0 Registration Environmental Protection Agency 

### 0 Amendment Washington, DC 20460 [2] Other opp Identifier Number 

## 252964
Application for Pesticide
- Section I 1. CompanylProducl Number 777- 68 2. EPA Product Manager Velma Noble 3. Proposed Classification

4. CompanylProduct (Name) Lysol Brand Pre-Moistened Bathroom Touch
- Ups Disinfecting Cleaning Wipes PM' 31 

### [2] None 

# o Restricted

5. Name andAddress ofApplicant(Include ZIP Code) Reckitt & Colman Inc. 1655 Valley Road Wayne, NJ 07474 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) (b)(I), my product is similar or identical in composition and labeling 

### to: EPA Reg. No.

# ------------------1 

# o Checkif/his is a newa.ddress Product Name Section -II 

# o Amendment
- Explainbelow. 

## D Finalprimedlabelsin response 10 Agency letterdaled 

# o Resubmission in response 10 Agency letterdated 

## 0 "Me Too"Application 

### [Xj Notification- Explainbelow. 

# n outer- Explain below Explanation: Use additional page(s) if necessary. (For Section I and Section 11.) Notification for the following alternate brand names: Lysol Brand Antibacterial Wipes

- Lysol Brand Disinfecting Cleaning Wipes Lysol Brand Disinfecting Wipes Section - III

Printed on package 5. Locationof Label Directions On Label 

# o On labeling acccmpanyinq product 2. Type of Container 

# o Metal 

### [gJ Plastic 

# o Glass Paper 

# o Other (Specifiy) No. per container water Soluble Packaging DYes 

## IZl No If "Yes" Package wgt. No. per conlainer

4. Size(s) RelailConlainer 10,25,30,35,40 Pre-Moistened Toweleltes (7" X8") (Pouch) 

# o lithograph [8] Other X 3. location of Net Contentslnlo/malion label 

## 0 ccntalner t. MaterialThis ProductWill Be Packaged In:

*Certification must be submitted

6. Manner inWhIch label isAffIxedto Product 

# o Paperglued 

# o Slenciled Pre-Printed plasticwraplPre-Prlnted Cardboard box Section -IV 1. contact Poirrl (Comptete ilems directlybelowforidentification of individual10 be canlacted, ifnecessary, toprocess this application) ;;l73·J86-7391 Name TItle Telephonef'lf'. ("1r.lude Area Bruce Paolella Senior Requlatory Affairs Specialist Code) Certification I certifythat the slatemenls I havemade on this form and all attachmenIs theretoare true, accurate andcomplele. I acknowledgethat anyknowingly false or misleadingstatement may be punishableby fine orimprisonment or both underappncable law. 6. Date Applicaton Received (Stamped) 3. TitleSeniorRegUlatoryAffairs Specialist 4. Typed Name Bruce Paolella 5. Dale December 29, 1999 EPA Form 8570·1 (Rev. 8-94) Previous editions are obsolete White· EPA FIle Copy (origina,) renew- Applicant CopyReviewer ID Submission No. Data Package No. 

# 5 

# « cf

# 'lcfI;

# .s --., B?:f)/

# 73d

# 7

# f

Service Person I I(C) Certification / /(5) / / IR) Non-residential Use Only

" I (N) Not-AJ?plicable



## 1401 Date Received by PM 

# ] !Ie- 

# I! I,) 

# I? 1/ 

# I .. -o DAY YR /; (2) Unconditional /' / IN) No

125

## IProposed Classification: 

### 1301 final Classification: II (R) Restricted I 

### 7 (R) Restricted 

### LJ (G) General " / (N) Not Classified 

### lEI Date on Application: 

### 1041 EPA Received Date: 

# 1/1d..//,d-19 1/1 

# TII,JI/ 

# Isl:L,u1 toO. DAY YR 1-0 DAY YR 

### laoI Method of Support: 

### 120/ Registration Type: I I (1) Conditional CODIr.K; FOFH FOR APPLICATIOO'S roR RECISTRAnOO/AHENCMEN!S file Symbol/Reg. No.

# 7 2?-i:;Y PM.:S ( Action Cede 

### 1 101 Descriptor (Amend/ResUbmis!ons only) 

## 15 

## I Intrastate Call-in I I (Y) Yes 

## 1151 Child-resistant packaging



## L...I (1) Cite-All / / (4) Not Applicable / / (5) Not Suhnitted / / (6) 

### o.mer Sutmission 

### L--I (7) Total Submission 

### LJ (8) Selective IIethcd 

# :I R.E:SPCt'lSE RESK:NSE lXJE SEN! DATE REnJl<NED 

## coee llA

# " \1 

# 0 j'.} 

# I , EF PL

NDEB 

### TB DEB Reviewers Requested: 

### CH

EEB 

### EFGB /115 

## I FINAL Response 

# f

# 1 AcrICN code--J-L 7S-DAY**RE~SE** OOE J:ll\1E: L-!('l) Yes D(N) NoUNITED STATES**ENVIRONMENTA~** PROTECTION AGENCY



### L&F Products 

### 225 

### summit Avenue Montvale, NJ 07645 

### Attn: Lysol Brand PreMoistened Bathroom touch-ups 

### Disinfecting Cleaning Wipes EPA Registration No. 777-68 Amendment dated December 12, 1991 

### The labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, for the addition of IIHighchairs, Table ToPS and Counter Topstl to the use directions, is acceptable. A 

### stamped copy of the labeling 1s enclosed for your records. If 

### you have any questions concerning this letter, please contact**Ma~tha** 

### Delaney at (703) 305-6982. 

### sincerely,

John H. 

### Lee

# 17aJA Product

# Man~ Antimicrobial Program Branch Registration Division H7505C Enclosure

,

# , COHCURRI!HC!S SYMBOl. , 

# ....•.......•...... .............•..

# - .................. 

# .................. 

# ....,

# ............."

# .

# ............"

# ..... 

# ................... ................. SURNAME' OATE ) 

# .................. .....•........... 

# ................. .............. ,

# ... ................. 

# ....•....**,.,.~"**

# .... .

# ..................

# -..................

EPAFonn 132Q..1A (1190) PrlIIIedqnRecycled Paper OFFiCiAL FILE COPY ·u.s. GOYOI'M'IllI'II PrintingOIfk:o; 10112
- G20-lJ.!i6(40072New* USOIJ" Bran:! Pre-*:>istened Bath:r=n TcudHJps 

### DisinfectiTg Cleaning Wipes
Ready 

### to 

## nse. Travel Size (Pack) 

### o::tm:mS 16 rroividually 

### Wraw<d Prem::>istened 

### T=elettes (8" X 5 3/4") (Bex) 

### or 20 Pre-*:>istened 

### T=elettes (8" X 5 3/4") (l'I:>.Jdl) 

### or 25 Pre-*:>iste.'ll>d Wipes (7 1/2" X 10") (canister)

llOSPITALS NURSING lKHf:S 

## =rrcs tJ:E:NTAL OrrlCES SClCOlS VEI'ERDlARY OFFICES B:MLING=S HCJr.ELS RESTl\llRANIS 

## nw=CEm'El'S HlYSICIAN OFFICES llEAlJIll CIIJB3 1IMBJl.1lNCES KENNElS J\IRFClR:lS !'NLS GAS STATIcm roBLIC REST RIXMS roBLIC TELErnCm:S DIAPER OlANGING 

## a:um=
The 

### quick an:! 

### e=y way 

### to clean an:! 

### disinfect (sanitize)

Under lhl'! Federal Ins"clicida, Fungicide, and Rodenticide Act, 01 amended, for the**pe~ticid.** regisler"d under

# 7' '4 / n EPA Reg. No. j- ( 

# -,,-..r 

# ACCEPTED 

# JUN 1" 

# 1992 Toilets, 

### sinks ShOHerS, 

### 'n±s 

### Tile, Enattel, 

### Pon:elain Garbage cans, Diaper Pails Nursery 

### Tele;ilones 

### cabinets stcrage 

### & Pet Areas High Chairs Table Tops Counter Tops an:! 

### other hart! 

### surfaces anywhere yoo travel. Toilet 

### seats Kitchen, Eathrcans Laun::lry

# = Walls, Floors 

### Diaper 

### Olan;in; Counters



### Q.Jick • Convenient • 

### Portable

*Will only be used 

### for 6 nonths fran date 

### of intrcduction.


# 1()

## • -2-



### rox (P::X.X::!r) (O\NISTER) 

### pm.

Ready 

### to use, COllVenient: the 

### quick on:! 

### easy wayto clean on:! 

### disinfect (sanitize) 

### toilet seats on:! ather 

### !laId 

### surfaces. 

# ACCEPTED 

# JUN 171992

Canister Only 

### Cleans 

### Disinfects (sanitizes) Hartl 

### SlJrfaces The 

### quick, easy way to clean surfaces kill (hcusehold) gems L-

__



### ACl'IVE==: Alkyl (50!C14, 40% 

# c." 10% C16) 

### DiJnethyl =1 

### 1Il:1=n±Qm O:IlorIQes INER:l' 

# IN==: 

# = 0.28% 99.72% 100.00% 

### KEEP 

### cor OF REACll OF 0fIll:Ilm CAllI'ICN: 

### see 

### reck panel 

### for additional precautionary stateIrents• 

### Does 

### not inclu:le 

### weight of dry 

### wipe. EPA !leg. No. 777-68 EPA 

### Est. No. 777-IL-l, NJ-2: 52631-NJ-DOI. 59368-50-001. 41925-1<1 (See Eottan)



# rt]

# iliC CEPTED 

# I JUN 17 i99'l !**U~C"'I** the Federoj Insecticido,

Fun"ki""" ,,,,,0. R",hmticidc Act, ca omcnded, for the pl!sticido registerod under

# 77 / i> EPA 'Rog. No.

- k?if
Pre-Moistened Bathn:an 

### Tcuch-Qps 

### Disinfec:t:irq c:leanirlq Wipes !!be 

### fast convenient way 

### to clean m1d 

### disinfect (sanitize) hard 

### surfaces anywhere 

### y'" travel. Use 

### them a1 

### bathrt:an surfaces. 

### toilet seats m1d teleji10nes 

### in malls, 

### restaurants, gas stati=, ahports, 

### rest steps, any p.Jl:>l.ic place (facility) \/here 

### germs er bacteria my I:>e a 

### concem.

!!be 

### fast ccnvenient 

### way 

### to clean m1d 

### disinfect (sanitize) hard 

### surfaces. Use them 

### in toilet 

## areas, UI"'der sinks, siclt rcx:Il'IS, 

### shc::1HerS, 

### bath 

### 'bJ.'bs, 

### patient dlairs, 

### exa..'"nination tables, garbage pails, q::eratories, stretchers, lal::oratories, cuspidors, door harrlles r 

### meel 

### d1airs, o:::wlte.rst 

### and. 

### other 

### places wnere genns 

### or bacteria 

### 1Il3y be a 

### ccrcem, N<:M* 

### LyscllO·Bran:l Pre-Moistene::lllothrt:an Tcuch-Qps 

### Disinfecting c:leanin; Wipes ore 

### the ccnvenient 

### way 

### to clean on:! 

### disinfect (sanitize) hard 

### surfaces.



### canister Ol'lly 

### For general 

### cleanirlq m1d 

### disinfecting (sanitizing) hard nOl1jX>= 

### surfaces. Ne.* 

### !liselIO 

### Bran:l Pre-M:>istene:l llothrt:an Tcuch-Qps 

### Disinfectm; c:leanirlq wipes ore 

### the ccnvenient way 

### to clean on:! 

### disinfect (sanitize) Ye>Jr hcUsehoJ.d 

### SlJrfaces. Each 

### pmroistene::l, disposal:>le wipe 

### is treated 

### with a special cleaner that actually 

### kills germs - even the 

### ge:rns that 

### cause cdcrs
- 

### 10herever yo> 

### use it. No bottles, nc SPOlliles. nc 1!leSS. 

### Effective disinfecting (sanitizing) has 

### never been 

### faster or easier. Unplug small electrical awliances before cleanin;. Not reoc:mnen:lej 

### fer polished er 1laIe weed 

### surreces,



# * Will cnly 

### be used 

### fer 6 lrOnths fran date 

### cf intro:luoticn.

# , !OX r!WO!) rCl\NISTER) nm, 

### MCK ra:NI',1 Directions far use: It 

### is a violaticn of fEderal law 

### to use 

### this product 

### in a llliOI1l1eI' 

### iT=nsistent 

### with its labeling. m CIDll 10ND S1>NITlZE lIMD stlRFAC:ES 

### (namIm mIIBl'**~)** 

### : 

### Use a :tresh 

### tc>oelette 

### to wipe surfaca. Flush 

### ar 

### tess dirty 

### wipe 

### away, All"" surface 

### to 

### %'elIl!lin wet far 30 

# se=m. !l'o 

### sanitize heavily soiled surfaoas. :repeat with 

### a clean 

### t.D,..1eJ.ette.**~ot** intended for personal hygiene. 

### m CIDll 10ND**DIS~** 

### mIIBl'**~I** Use 

### a fresh 

### ta.'elette to >lipe toilet 

### seat. Flush dirty wipe 

### away, All"" surfaca 

### to l:6llain wet 

### far 10 

### >ninutes, !l'o 

### disinfect heo;vlly soiled surfaces repeat with a clean 

### ta.'eletta. 

### m CIDll 10ND**DIS~** 

# = BORFl\CESI 

### Use a :tresh 

### ta.'elette aoc::oxUirq 

### to ctirections alleYe. Flush 

### ar 

### tess dirty 

### wipe rs:.ray. Full 

### up tab ard 

### :remove 

### llUge 

### cxwer. Insert triangular 

### locp 1:.hr=gh 

### slits 

### in C1:Ner.**~~** 

### first sheet 

### in canister 

### center of 

### roll 1:.hr=gh 

### locp. !laplaca 

### cxwer. Full 

### locp Qlly back 1:.hr=gh 

### opening. Full eadl 

### sheet 

### up ard 

### slightly to the sie!e. Always 

### snap lie! sec=ely shut between 

### uses to 

# D prevent 1l"Oisture 

### loss. ' 

# ACe EP TE 

# JIJt{ 17 1?J?J'l.

Peel back 

### the fmnt label sl""ly. Rem::lve ta.'elettes 

### as needed. Re.

....j 

### p::uch by 

### finnly l:Ul1J'ling thUllb 

### over the 

### label. !¥sOl" Brarxl 

### Pre-tloistened Eathroan Tc»dl-tJps 

### Disinfecting Cleaning' 

### Wipes

_ efficacy stan:'!aIds 

### for (hospital type) 

### disinfectant (sanitizing) wipe. Kills Influenza A2 

### (Japan) ard Hexpes 

### Siliplex 'lyPe 1 Vi%uses ard 

### streptocoo::"s faecalis 

### germs. Inhibits ""Ie! ard 

### ndle!ew 

### in clalrp ard 1IUSl:y 

### places. Kills Iluman 

### Ilr<;umcxleficiency Virus 'lyPe 1 (IIIV-1) (AIIlS Virus) 

### en precleaned emrhoc"

....

### "",e>"'-'ltaJ, surfaces/ci>jects previcusly soiled with bloo:ljlx:dy fluids 

### in health 

### care sett:!rqs 

### ar ather settings 

### in whidl there 

### is on expec:l:ed 

### liltelihoocl of soiling of

. inanimate 

### surfaces/ci>jects with bloocl or :bocly fluids, ard 

### in ..nich the 

### surfaces/

ci>jects liltelyto be 

### soiled with bloocl 

### or Ixxly 

### fluids 

### can be 

### associated >lith the 

### FOtential for transmissien of human 

### hmmocleficiency 

### viJ:us 'lyPe 1 (IIIV-1) 

### (associated with AIIlS) • 

### Special Instructions for Cleaning' ancl 

### Ilec:ontaminatien 1lgainst !lI'l-1 

### of SUrfaces/Cbjects SOiled with Bloocl,ll3o:ly 

### Fluids. 

### Ferscml Prote::tion: When hanclling items soiled >lith bloocl 0,,"**~.-o:y fl~'"**  

### use clisposa:ble latex 9'loves, 9''''''''', Il'aSks 

### or eye coverings. Cleaning 

### Proce:lures: '.!llorooqhly clean 

### bloocl ard 

### other :bocly**fl',B~** 

### fran "",faces ard 

### ci>jects with a 

### wet tCJ<'elette. Use a secord 

### wet tcMelette 

### to clisinfectant. 02ntact Tilr<!: All"" to stard 10 

### minutes. Disposal of Infecticus Y",terials: Bloocl ard 

### other :bocly fluids 

### &1c<.le! be 

### autoclaved and 

### disposed of ao::orcling to local regulations for**.inf«=l:i",,~** "",ste 

## disfosal.

•

## rox (P;X1qi) (CANISTER) 

### nm. E.';CK ra:NI.l
w.ECAUl'!ctlARY S'l1Il'EMENIS HAZARrS 

## ro IlL1lOOlS AND =C 

### AN:rmIS 

### Caution: Y

..

### y cause eye irritaticn. Avoid ccrrt:ac:t with 

### eyes. Wash han:Is after 

### use. ST1lTEMml' 

### OF iRIoCI'l=. TRFA!M!m' In case, 

### of <!'je 

### oontac:t, 

# = flush 

### eyes thort:llXJlUy with 

### water, renJ:l\'e any 

### oontac:t lens, an:l 

### conti:nae 

### to flush 

### eyes with 

### plenty of 

### water for a least 15 lllinutes. 

### Call a I'bysician 

### if irritation persists.

S'IORI\GE AND DIS= 

### sterage: stere unopened 

### package in 

### a 0001, tl:l:y 

### place. Container Disposal: P.lt enpty 

### be" (pooch) an:l 

### envekcpes in trash 

### collection.

Canister Only SlDRAC;E AND DIS= 

### Storage: store in 

### original ocntainer in 

### areas inaccessible to small children. stere canister in 

### a 0001 place. Disposal.: Dc 

### not reuse enpty 

### oontainer. Wrap an:l 

## P't in trash.
11arnlfactured 

### by L & F Products M:>ntvale, New 

### Jersey**0764~.** 

# ACCEPTED 

# JUM 111992

b Fedetol Insectieid

...
, u nde: de ond Rodenticide Aet.

Funglc 1**~'..d** lot the pesticide a.**cm.'~** , 

# 7L I" rJ te9illtexGd undex7 

### f"P EPA Rog. No.

## •

A:lJ;yl 

### (sot l:.14' 40t 

# Cu. :lot l:.1S) 

### Ilil:e'"Jlyl**~\llIl** 

### Ol1cril1M 

### • 0.28'

• 

### I:bes I'lI:>t 

### Ux:lu3a we.i¢lt of 

### vip. 

# = cur or m.al 

# or 0llJ.Il\Dl 

### C'IlmCN

ffit-+D!S'l'llllD 

## =I.. R 3WlD !lo'JlVCQI 

### 'l'CXJOl-'OPS IlISIlmCl'lm CI.D.Nm:; 

# w=

!:l'A 

### Ila;'. 

### No. 777-68 !:l'A 

### !st. 

### No. 52631-11J-OOl

L & F Products

.•: t.bt.t.tlJPl1 

### H:nMle, N:T 07&45

### DP BARCODE: D173279 CASE: 008454 SUBMISSION: S409865 DATA PACKAGE RECORD BEAN SHEET DATE: 01/17/92 Page 1 of 1


## * 

## * * CASE/SUBMISSION INFORMATION 

## * * * CASE TYPE, REGISTRATION ACTION: 300 ADMN-LBL REV AMND NO DATA CHEMICALS: 069105 Alkyl* dimethyl benzyl ammonium chloride *(50% C14 00.2800%



### 258 254 ROOM: CM2 ROOM: CM2 703-305-5675 703-305-6982 03/12/92 ID#: 000777-00068 LYSOL BRAND PRE-MOISTENED TOUCH-UPS DISINFECTING CLEANI COMPANY, 000777 L & 

### F PRODUCTS PRODUCT MANAGER: 31 JOHN LEE PM TEAM REVIEWER: MARTHA DELANEY RECEIVED DATE: 12/13/91 DUE OUT DATE:


## * * * DATA PACKAGE**INFORMA~ION** 

# * * * DP BARCODE: 173279 EXPEDITE: N DATE SENT: 01/17/92 DATE RET.: CHEMICAL: 069105 Alkyl* dimethyl benzyl ammonium chloride *(50% C14 r DP TYPE: 001 Submission Related Data Package 

### ADMIN DUE DATE: 03/02/92 CSF: Y LABEL: Y ASSIGNED TO DATE IN DATE OUT DIV : RD / / / / BRAN: AB / / / / SECT: EETMS / / / / REVR: // //**~CONTR:** 

### / / / /


## * 

# * * DATA REVIEW INSTRUCTIONS 

## * * * PLEASE REVIEW LABEL FOR NEW USE SITES



## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

## * * * DP BC BRANCH/SECTION DATE OUT DUE BACK INS CSF LABEL



## , 

# .

, 

### ,Date 

### EFFICACY EVALUATION AND TECHNICAL MANAGEMENT SECTION EFFICACY REVIEW - I**~~.MICROBIAL** 

### PROGRAM BRANCH 

# 'ILo'
. OUT 05-21-92

# ~iewed by-""""i""'f';'t§!:";;-"'-------- _-"0-'25;::-
... 2
...

1;::-,,,9
...

# 2~ _ EPA Reg. No. 777-68
None EPA Petition or EUP 

### NO.**~~~ ~--------**  12-13-91 

### Date Division Recei'ved --"'=-"""="'- -,-:.

_ 

### Type Product Hospital disinfectant/Impregnated Towellette 

### MRID No (s) No data were sUbmitted for review.


### PM-31 Product Manager ""''-''''''-

_ 

### Product Name Lysol Brand Pre-Moistened Touch-Ups Disinfecting Cleaning Wipes
Lehn 

### & Fink Products. Company Name**~"""l!!l-"-"_'d!A...L'-"""''''''''_'** 

### _ Submission Purpose The addition of new use sites. 

### Type Formulation A single use disposable impregnated towelete.
Active Ingredient (s): % 

### Alkyl (C14,SO%; C12, 40%;**C16~** 

### 10%) dimethyl benzyl ammonium chloride 0.28
202.0 Recommendations 202.1 Claims Related to HUman Health 203.0 Label Comments: The addition of the highlighted use sites**~or** th,**propo~~d** label dated**l2~13-91** are acceptable.

## (1-\,t~",**~cJI.U.** 

# 16r'/**(o~ \O~0**  

# (")')

2

# In

December 12, 1991

Mr. John Lee (PM-31) Antimicrobial Program Braoch Registration Division (H7505C) U.S. Environmental Protection Agency Crystal Mall, Building #2, Room 246 1921 Jefferson Davis Highway Arlington, VA 22202 RE: Lyso18 Brand 

### Pre-Moistened Bathroom 

### Touch-Ups Disinfecting CLeaning Wipes 

### EPA Reg. No. 777-68 Amendment to add "High Chairs. Table Tops and Counter Tops" to areas of use Dear Mr. Lee: 

### L&FProducts would like to amendthe above listed productto include "High Chairs, Table Tops and Counter Tops" to the use areas of the label (box, pouch, canister). In support of 

### this amendment, enclosed are the following: 

### I) Applicationfor PesticideAmendment,EPAForm. 8570-1,OPPIdentifierNo. 169925. 2) 

### Six (6) copies of the revised Master Label (box, pouch, canister} for Lysol" Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes, (EPA Reg. No. 777-68). One (I) copy has been "HIGHLIGHTED" for ease ofreview. 

### Your attention to this requestedamendment is appreciated. If

### you have anyquestions, feel free to call me at (201) 573-5329.

Si/eIY, 

# 7 

# P

# fa~~**/fit~V''16 ~.**  Paul J. ger Manage, PA tory Compliaoce RT:cjc 

### lencls
cc: Martha Delaoey

L&F Products 225 Summit Avenue, Montvale, NewJersey 07645-1575 (201) 573-5700

# 169925 Form Aoorovecf OMB No. 2070-0060.Acorcvatexmrestt·30·93 UnitedStatesEnvironmental Protection Agency 

# B Registration OPP ldenlifierNumber Office01Pesticide Programs (H7505C) Washington, DC 20460 x 

### Amendment 

### Application for Pesticide: Other

. Pleast! r,,"dInstructions on rev",.. b.forttcomplDtlng form. 

# (A)&EPA

Section I t. Company/Product Number 777-68 4. Company/Product(Name)**Lysol_~K)** Brand Pre-**~oistened** Bathroom Touch-Ups Disinfecting Cleaning Wipes 2. EPAProductManager 

### J. Lee PM< 13 3. ProposedClassilicarion

5. Nameand Address ofAppflCant (Include ZIP Code) L&F Products 225 Summit Avenue Montvale, NJ 07645 

# o Check ifthis isa newaddress 6'. Expediled Review. In accordance with FiFAA Section 3(c)(3) (b)(i), myproduct is similar Ot identical in composition and labeling to: EPA Reg. No

..**----'--~** _ Product Name Section II ..

'-.' Finalprintedlabelsin response10 AgencyI6tterdaled, '- '-

__**'-~--1** "MeToo" Application. omer • explainbelow. 

# -

- Notification- Explain below. Resubmission in respcnsajo Agency letter dated

_ Amendment - Explainbelow

Explanation: Useadditional page(s)jJ necessary.(For section I andSectionII.) Addition. of "High Chairs, Table. Tops and Counter Tops" _.to areas of use

Section III t. Material This Product WIll Be Packaged In: '. ' 2. Type of Container

Glass , Paper Ojher (SpecifylL- 

### 1 No. per container I Waler SolublePackaging 

# B y" No If ·Yes: Package wgl. No. per container Certrficatlon mustbe sub 'iH.A Child-Resistant Packaging Unit Packaging 

# 8 y,,' 

# 0 Yes No DNo 

## hll,,·,;Y,"",-::c----...,.,---+:==.==-----,,---J Unit Packagewgt. 3. Location of Net ContentsInformation



# o Label 

## 0 Container 4. Size(s) of Retail Container 5. Locationof Label Directions 

# El a n Label On Labelinc accomcanvlnc product· 6. MannerIn Which Label IsAffixedTo Product 

# § Uthograph Paperglued Stenciled 

# o Other(**.~**

Paul J. Kruger Section IV t. ContactPoint (Complere ftemsdirectlYbelow foridentification ofindividualto becontacted, ifnecessary, Name Title Manager, EPA Regulatory Compliance (201) 513-5329.

. y**~.** Certitlcatlon I certify that thestatements I have madeon this form and a11.;l!tachmenl$ theretoare true, accurateand c6mJ:.-I;;ta. I acknowledge thatany knowingly Jalse or misleading statementmaybe punishableby fine or imprisonmentor both**Undera~icablelaw.** / / 3. Title EPA ManagE;r, Regulatory Compliance 6. DateAppliCation Received -. 

### :**19~ped,>**



# .." q
; 

### - . 

# . . .. . 

## .,..,. t1

. 

## • ',1.'**.,~** 

# , ", 

### .'TO:


### NO NEW t.ABEt. [ 

### ATTACHED NOTIFICATION

# PM~ 1\ ';:0/ FROM: REG. SUPPORT BR. 

# "y**~9** NO 

# """''1'''-

# 109 EPA REG.
. I \ 

### NEW

## -~ t.ABEt. ATTACHED COMPANY NAME,

__ NEW CSF ATTACHED
********.**.***** ••••

### **.**••••

### *.**••*******••

### **••••••• ************* 

### THIS IS AN ADDITIONAt. BRAND NAME THIS

# _~A,,- THIS IS A CSF PERMITTED ONOER PR NOTICE 88-6 IS A t.ABEt. CHANGE PERMITTED ONDER FR NOTICE 88-6 

### .****••*••• **.****** •••••••••• 

### **••••••••

### ******•••••*•••

### ***••••

## ***.

# ~IS WAS SENT TO SIG FOR CODING AND/OR MICROFICHING FIt.E IN JACKET

# 149969 

# &EPA Please read instructions on reverse before call0r-.dUng form. Form Approved

.........,6 No. 2070-0060. Approval**ex~ires** 6-30-90. United States Environmental Protection Agency OPP Identifier Number Officeof Pesflcide Programs (TS-767) Washington, DC20460 X NOTIFICATION 

### Application for Pesticide: 

# D Registration [!]Amendment
1. CompanyJProduct Number 2. Date 777-68 July**2~** 1991 3. Product Manager John Lee (PM-31) 1 4**.~. prop~os.ed**  c;'asnsUlcaf,onRestricneral ted 5. Name and Addre!ls of Applicant (Include ZIPCode) L £. F Products 225 Summit Avenue Montvale, NJ 07645 

# In Check if thls Is a new

## addre~s 6. Product Namo
-

__ LysolR Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes



# . .",

.

v

# I.,,,, 

# nr.:na1 printed labol 

# n Other (explain be/owl Date of Letter
AMENDMENT Addition of IlHigh Chairs, Table Tops and Counter TOps" to areas of use 

### NOTIFICATION Two additional EPA Establishment Numbers .:'

Section III

Unit package wgt 1 No.per container Package weight INo. per container

. Location of Net Contents Intormation 4. Size(5)of Retail container 

# In Label 

# -ri Container 

# R On label On material accompanying product 5. location of label Directions 6. Manner in Which label Is Affixed To Product Ulhograph 

# 0 Other (Specify) f----- Paperglued Stenciled
t. Contact Point (Complete items directlybelowforidentiflcalion ofindividuafto be d

... Name Paul J. Kruger Title Manager. EPA Regulatory Compliance Telephone No. ('nC'UdeArea Code) 201) 573-5329 CertificatIon I certify that the statements I have made on this form and all attachments thereto are true, accurate, and complete. I**aCknOWledg~e** that any knowingly false or misleading statement may be punishable by fine or imprisonment or both undw ap",'""b1e 

### 'c",wO' --- --,'''''';;-,-:- -=:::-:- 

### ---1 2. Signature 

## (j**;JI/~** 3. Tille Manager. EPA 

# !Cz,.vv(, (j) ....". ,7....

- Regulatory Compliance 

# f 4. Typed Name ( / 

# U 5. Date Signed Paul J. Kruger July 2. 1991 EPA Form 857Q..1 {Rev.4-88 Previouseditions are obsolete.**HI~** IGHTED COPY

B:lX (P<:l!X'Il! (C>.NIS'I'ERI J.l,B&L



## * New USOIll> Bran:! Pre-M:>istened BathIocm ToudHJps 

### Disinfect.in;r Cleanin:] 

### wipes
Read'{ 

### to Use 

### Travel size (Pack) 

### crn:r.ENIS 16 In:!ividually Prem::>istened '1'c:Melettes (8" X 5 3/4") (Box) 

### or 20 Pre-M:>istened '1'c:Melettes (8" X 5 3/4") (Pcudl) 

### or 25 Pre-M:>istened Wipes (7 

### 1/2" X 10") (canister)



## HOO= NlJRSlNG InIES CLINICS omrALOFFICES SOlOOrs VEI'ERINARY OFFICES B:MLmG ALlEYS IDI'ELS RESTAlJRANIS D.W CARE CENI'ERS rnYSICIAN OFFICES llEAllIJj CIIJBS AMIlJIANCES KENNELS AIRroRIS MAllS GI\S 

## =005 roBLIC REST mcM; roBLIC TEIE!'llCW!S DIAPER OlANGlNG Cl:UII'ERS


### '!he quick and 

### easy 

### way 

### to clean and 

### disinfect (sanitize) 

### Toilets, Sinks ShcMer.;, 

### Tile, Enamel, Fbrcelain Gart:Jage cans, 

### Diaper Pails Nursery 

### Telefhones cabinets storage 

### & Pet Areas High Chairs Table Tops Counter Tops and other hard surfaces anywhere 

### you travel. 

### Toilet 

## seats Kitchen, Bathroans Laurdry l10an 

### Walls, Fleers Diaper 01an;Iin; COUnters

Qrlck • COnvenient • Fbrtable



## *

will only be used 

### for 6 nonths fran elate 

### of introduction.-2-
!'?X lrot=l (C>NISTER) IAm:L 

### FRJNT 1!XN',)

Ready 

### to use, convenient; the quick 

### am easy way 

### to clean am disinfect (sanitize) 

### toilet seats am other 

### ham 

### surfaces.

canister only 

### Cleans 

### Disinfects (sanitizes) Hard 

### surfaces quick, easy way 

### to clean surfaces am kill (hcusehold) 

### ge:cns 

### L-

__

A=vE lNGREDIENT: A!J<Yl**(50~_C14'** 40% C, 2, 10% C, 6) DllIlethyl =1 AlmOClnIarn C1J.orIdes INERT lNGREDIEID'S: rorAL 0.28% 99.72% 100.00% KEEP 

## oor OF REAQI OF 0lII.lEEN CAlJI'I00: See back panel 

### for 

### additional precautionary staterrents. Does 

### not include 

### weight of dry 

### wipe. EPA Re;J. No. 777-68 EPA 

### Est. No. 777-IL-l, /U-2; 52631-ID-oOl. 59368-SC-00l, 41925-WI (See Bott:an)-3-


### rox (p::uon (CANISTER) lAw.



### Travel Size 

### MI::!> Pre-l>bistened Bathroan 

### Tcud1-t1ps Disinfectin;J Cleanin;J Wipes fast o:rJVenient way to clean lll"ld 

### disinfeqt (sanitize) hard 

### surfaces anywhere 

### y= travel. Use a'l bathroan 

### surfaces, toilet seats lll"ld 

### tel.,.nanes in 

### mlls, 

### restaurants, gas 

### stations, aiJ:port:s, :rest stqls, 

### any p..1blic place (facility) where 

### genns or bacteria 

### may be a ooncern. NriM

## ***LYSO~** Bran:i



### n>e fast ccnvenient way to clean an:! 

### disinfect (sanitize) hard 

### surfaces. Use them 

### in toilet areas, urxler sinks, sicR roans, shc:wers, 

### bath tubs, 

### patient 

### chairs, examination tables, garbage pails, q::eratories, stretchers, laboratories, cuspidors, door harxlles,**~ee1** 

### chairs, counters, an::1 

### other 

### places \ohlere germs or 

### bacteria may·:t::e. a concern. New* Lysol" Bran:i Pre-Moistened Batllroam 

### Tc:<Jdl-t1ps Disinfectin;J Cleaning Wipes are the convenient way 

### to clean an:! 

### disinfect (sanitize) hard 

### surfaces.



### canister Only 

### For general cleanin;J lll"ld 

### disinfectin;J (sanitizing) hard 

### nonpo= surfaces. New* I?tsol" Bran:i Pre-l>bistened Bathroan 

### Tc:<Jdl-t1ps Disinfecting Cleanin;J wipes are the 

### convenient way to clean an:! 

### disinfect (sanitize) 

### yoor hcusehoJ.d surfaces. Fadl preroistened, 

### dizl;a;able wipe 

### is treated 

### with a special cleaner that actually kills genns - even the genns 

### that cause cdors

- wherever 

### y= use 

### it. No bottles, no S]?Ol"ges, m mess. Effective disinfectin;J (sanitizing) bas never 

### been faster or easier. Unplug 

### small electrical awliances before cleaning. Not**~ed** 

### for polished or bare wood 

### surfaces.



## * Will only ba used 

### for 6 lIOnths fran date 

### of introduction.

### -4- lPX (lWQIl (C1INISTERl !lim, 

### B1\CK 

## <am·l Dixections for use: It is a violation of federal law to use 

### this product 

### in a 

### manner 

### :inconsistent with its labelin:]. '10 cu:1>N AND SANI'l'IZE Il1lRD SORF1\CES (m:wDIN3 '10= SEM'S): Use a 

### :fresh tcMel.ette to wipe surface. Flush or toss 

### dirty 

### wipe away. Allo« surface to 

### reIIain 

### wet for 30 seconds. 

### sanitize heavily soiled surfaces, repeat with a clean 

### towelette.**~ot** intended for personal hygiene. '10 cu:1>N AND DISINFECT '10=

# =. Use 

### a fresh 

### towelette to wipe toilet seat. Flush dirty 

### wipe away. Allo« surface to 

### reIIain 

### wet for 10 

### minutes, disinfect heavily soiled surfaces repeat with a clean 

### tcMel.ette.

. '10 cu:1>N AND DISINFECT 0'nlER BMmO:ti SORF1\CES: Use 

### a fresh 

### towelette acx::omin;J to directions above. Flush or toss 

### dirty 

### wipe away.

canister 

### Only Pull 

### up tab an:! 

### rencve laxge 

### cover. Insert 

### trian;JUlar loop through 

### slits 

### in cover',**~d** 

### first sheet 

### in center of 

### roll through 

### loop. Replace 

### cover. Pull loop back**through~.** 

### Pull each sheet 

### up an:! 

### slightly to the 

### side. Always snap lid securely shut batween uses 

### to prevent 

### ncdstnre loss.

Poodl Only

# I-----~_·**~-~** needed. Reseal 

### poudl by 

### finnly 

## runninJ thumb over the 

### label. I;>sol"' Brand 

### Pre-Moistened Bathroan 

### Toodl-tJps Disinfectin:] Cleanin:] Wipes meets efficacy stardards 

### for (hospital type) 

### disinfectant (sanitizin:]) wipe. Kills Influenza A2 (Japan) an:! 

### Herpes Sil!plex 1 Viruses an:! 

### streptococcus faecalis germs. 

### Inhibits IOClld and 

### mildew 

### in danp an:! llUlS1:y 

### places. Kills Human 

### In:nunodeficiercy Virus 1 (HIV-l) (AIJ:S 

### Virus) on precleaned 

### envirorJmental. surfaces/ci:>jects previously soiled with blood,llxxly fluids 

### in health care settin:]s 

### or other settin:]s 

### in 'Nhich there 

### is an expected 

### likelihood of soilm;, of 

### inaniJnate surfaces/ci:>jects with blood or body 

### fluids, an:! 

### in 'Nhidl the 

### surfaces/ ci:>jects likely to be soiled with blood or body 

### fluids can be associated with the 

### potential for t.ranl;onission of hurran i:Jmmodeficiercy virus 1 (HIV-l) (associated with AIm) • 

### Special Instructions for Cleanin:] an:! 

### Decontamination**~inst ~-1**  

### of Burfaces/Ci:>jects Soiled with Blocd,lBody Fluids. f'el;sonal 

### PJ;o!:ection: When han:l1m;, i1:ens soiled with blood or bc:rly 

### fluids use 

### disf;osable latex gloves,**g~,** 

### nasks or eye cover1n:Js. Cleaning PJ;oc::e:lures: 

### TI1orooghly clean blood an:! 

### other body 

### fluids fran surfaces an:! 

### ci:>jects with a 

### wet tcMel.ette. Use 

### a second 

### wet to«eIette to disinfem.ac. o:>ntact Time: Allo« to stand 10 

### minutes. Pisposal of Infectious Materials: Blood and 

### other body 

### fluids shc:W.d be 

# r:**~=~** and disposed 

### of acx::omin;J to local regulations for infecticus waste 

# r;2:>-5- 

### !'Ox rFaJC11l rCI\N!STERl 

### lARI\!· BACK 

### ra:Nr.l
ffiECAUl'IOOARY STA'TIMImS HAZARlS TO HUMANS AND tnlESl'IC A1m!AIS 

### caution: May 

### cause eye :irritation. Avoid 

### contact with eyes. Wash 

### harxls after 

### use. STATEMENI' OF ffiACI'ICAL In 

### case of eye 

### contact, IMMEDIATELY flush 

### eyes thoralghly with 

### water, :rem:we 

### an:t contact lens, an:1 

### continue 

### to flush eyes 

### with plenty of water for a least 15 1lIi.I)utes. 

### call a ;hysician 

### if 

### irritation persists.



# = AND DISrosAL 

### storage: store unopened 

### package in 

### a cool, dl:y 

### place. 

### Container DiSposal: Put enpty 

### box (pouch) and 

### envelopes in 

### trash 

### collection.

canister only 

# = AND DISrosAL 

### storage: store in 

### original container 

### in areas inaccessible 

### to snall children. 

### store canister in 

### a cool place. Disposal: Do 

### not 

### reuse enpty 

### oontainer. Wrap and p.rt: 

### in 

### trash.
Manufact:ure:l by L 

### s F Products M:mtvale, New' 

### Jersey 0764S.

### •

AlIcy1 

### (5ot 

# C1A. 40t

# s.z. lot CUI Dimethyl l!enzyl 

### Ama11\llll OllarlAM 

# = IN:lR!:OIEm'S: 

### . 0.28'



### tees r>ot inclu:la weight of 

### chy wipe. ;m;:p CVl' OF 

### RE'AOI OF oa:ILI!m o.urIQl



### see "-Iter 

### c:alta1ner for aMitiClllll 

### precautions lII'ld 

### direct.l.ans for WIll.



### EPA**~.** 

### No. 777-68 EPA 

### Est. No. S2631-NJ-00I 

### Net 

## o:rrt:arrt:a: L & F Products 

### H:rJtvale. NJ 07545

# III

July 2, 1991

Mr. Jolm Lee (FM-31) AntiJnicrobial Program Branch Registration Division (H750SC) 

### u.s. Environmental 

### Protection 

### hJerq Crystal Mall, iill.lding #2, Roan 711 1921 

### Jefferson ravis Highway Arlington, VA 22202 RE: Lysel'" Brani Pre-Moistened Bathroom Touch-trps Disinfectin;l Cleaning Wipes EPA Reg. No. 777-68 

### AIrerrln"ent to add 

### "High Chairs, Table Tops arrl Counter Tops 

### to areas of use Dear Mr. Lee: L & F Products >IOOld like 

### to amend the above listed product 

### to include ''High Chairs, Table Tops and Counter Tops" 

### to the use areas of the laJ::el (box, pouch, canister) • In SUR,X)rt 

### of this 

### amerrlment, enclosed are the follCMirq: 1. Application for Pesticide 

### AIrerrln"ent, EPA Form 8570-1, OFF Identifier No. 149969. 2. 

### six (6) 

### copies of the revised Master label 

### (box, PJUch, 

### canister) for I¥sol Brani Pre-Moistened Bathroom Touch-trps Disinfectin;l Cleaning Wipes (EPA 

### Re:J. No. 777-68). One 

### copy has been highlighted for ease 

### of review. We are also notifyirg you of two 

### additional EPA Establishment Ntm!bers. UIE"SH are included on the enclosed highlighted label. 

### Your attention 

### to this requested. 

### is appreciated. If}u... have 

### any 

### questions don't hesitate 

### to call me at (201) 573-5329.

IDK:vv 

### attachment
L&F Products 225 Summit Avenue, Montvale,NewJersey 07645·1575 (201) 573-5700

### TO: ATTACHED NOTIFICATION PM 

# -t:Qo FROM:

# 3~G. SUPPORT BR.

EPA REG. NO. COMPANY NAME,

_ NO NEW LABEL NEW LABEL ATTACHED NEW CSF ATTACHED

*******************************************************************


### THIS IS AN ADDITIONAL BRAND NAME

_____

### T~S A CSF PERHITTED UNDER PR NOTICE 88-6

____

## L~HIS IS A LABEL CHANGE PERMITTED UNDER PR NOTICE 88-6

******************************************************************



### __**~HIS** 

### WAS SENT TO

____

## ~_ '"FILE IN JACKET SIG FOR CODING AND/OR HICROFICHINGPlease read instrucllons on reverse before com!-"vling form, Form Approved.
.......IIS No. 207D-0060. Approval expires 6-30-90. United States Environmental Protection**~ency** OPP IdentifierNumber Officeof Pesticide programs (T5-757 

# &EPA Washington, D 20460 

# 149915 Application for Pesticide: Registration x 

### Amendment

. 1. Company/Product Number 2. Date 3. Product Manager**4~~sed** 'Classitication 777-68 2/8/91 J. Lee (PM-31) I nfestric- xx General ted 5. Name and Address of Applicant(Inc/ud9 ZiP Code) L&F Products 225 Summit Avenue Montvale, NJ 07645

n Check if this is a

### ~ew address 6. Product Name 

### . Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes



### . ,11- 

### . I.**S~tiect** fiXlOther (exIJ/afn bBlow) Date ofletter nfesubmission ,

# .... '**n~nal** printed label NOTIFICATION Box Carton (only) back label

. Addition of phrase 'JNot Intended fo'rsPe

### rsonaL Hygiene!' -at-.'end" .' of DIRECTIONS FOR USE section. Section III t. MaterialThisProductWill Be Packa edln 2. Type ofGonla'mer Child-Resistant Packaging Unit Packag!ng Water-Soluble Packaging f- Meial 

# nyU FINO nyu nNo Plastic DYes 

# DNo If''Yes: If·Yes," 

### f- Glass

. Unitpackage wgt: 

### INo.per container Package weight 

### INo, per container 

### f- Paper Other (Spocify) 1.location of NetContents Information 4. Size{s) ofRetail Container 

# I

# n Label 

# -n Container 5, location of Label Directions 6. Mannerin Which Label IsAf(lxed To Product 

### r- Uthograph 

# o 00", (Specify) 

### r-

## R~nLabel r- Paper glued On material accompanying product Stenciled
t. Contact Point (Complet9 items dfrecflybe/owforidentification ofincffl/idllaltobe Name Paul J. Kruger Title Telephone No. (Inc/llde Area cca»; 6. Date Applicallon Rece'lvod ManaQer, EPA Regulatory Compliance (201) 573-5329 (Starn,oel.? Certification I certify**th;~a~tatements** I**~~Zade** on this form and an attachments thereto are true, accurate, and comrhlete. I ac**oWle~~trhat** any. nowingly false or misleading statement may be punishable by fine or imp scnmen both u r appli e law. ',""

# 2S;g""""~A/**~~o/JUA/** 3, Title Manager, EPA Regulatory Compliance 

# qo 4. Typed Name :rher 

# (j 5. Date Signed Paul J. February 8, 1991 EPA Form 8570-1 ( leN_4-88) Previouseditions are obsolete.February 8 1 1991 Mr. John Lee (IN-31) Antmcrabial Proqram Branch 

### Registration Division (H7505C) U. 

### S. Environmental 

### Protection Agency Crystal Mall, B.lllding #2, Room 711 1921 

### Jefterson ravia Highway Arlington VA 22202
RE: Lysel Brand Pre-Moistened Ba):hroorn Touch-Ups 

### Disinfecting Cleanirq Wipes EPA Reg. No. 777-68 

### Notification of Minor Label 

### Modification
Dear Mr. Lee: 

### '!his letter is 

### to notify you of a minor label l'OCldi.fication 

### to our Lysel Brand Pre-Moistenea Bathroom Touch-Ups Disinfecting Cleanin;J Wipes (EPA Reg. No. 

### 777-68). The mcx:lification is as follows: Box Carton (only) back label: 

### Addition of phrase "Not; inten:led. 

### for }?el':'SOlB1 

### hygiene" at the end 

### of the DIRECITONS FOR USE section. In suppor-t; 

### of the above, enclosed is EPA Fonn 8570-1, Application for Pesticide Amendment, 

### ow Identifier No. 149915. 

### Kindly note 

### this change ecccrdtrq'ty in 

### our file. Your cooperation is appreciate:l.

# /Jel~ PaulJ

# Kruv~ Mar«cqE>r., EP¥Regulatory Conpliance RTIY'lpk Attachment

Lehn& Fink Products 225 Summit Avenue,Montvale,NewJersey 07645-1575 (201) 573-5700 

# ql

### NO NEW LABEL NEW LABEL ATTACHED ATTACHED**NO~TION** 

### TO: PM ' 

### FROM:

## ~G. SUPPORT BR.

EPA REG. NO. COMPANY NAME,

__ NEW CSF ATTACHED*************~*********~************************************* * ****** ****** * ****** * ***



### _____ IS AN ADDITIONAL BRAND NAME THIS IS A CSF PERMITTED UNDER PR NOTICE 88-6 THIS IS A LABEL CHANGE PERMITTED UNDER PR NOTICE 88-6

******************************************************************

# ~IS WAS SENT TO SIG FOR CODING AND/OR MICROFICHING FILE IN JACKET



# qtr-63090 d NIB N 2070 0060 Ap Ap F r bf 

### or d·

EPA Form 857().1 (Rev.4-88) PreVIouseditions are obsolete.

ease rea mstru Ionson reverse e are corn;... mg crm. crm prove 

### . o. 0 prova expires 0 0 United Sialos Environmental ProteCtion**~ency** QPP Identifier Number Office of Pesttcide programs (TS-767 

# &EPA Washington, 0 20460 

# 149914 Application for Pesticide:

# EI Registration x 

### Amendment

0 1. Company/Product Number 2. Date 3. Product Manager 

# 14;;posed Classification 777-75 February 1, 1991 

### W. Francis (PM-32) t1 nRestric. x General ted 5. Name and Address01AppRcant (Include ZIPCode) L&F Products 225 Summit Avenue Montvale. NJ 07645


# In Checkif this is a new address 6. Product Name 0 Barrage Pine Action Cleaner



# . >n • 0 1. Subiect 

# n final printed label [Xl Other (8xn/ain below) Date ofletter i 

# n flesubmisslon 

### NOTIFICATION Alternate name of: R Brand Disinfectant Pine Action Lysol

. Section III 1. Material This Product Will Be Packa ad In 2. Typo of Containor Child-Resistant Packaging IUPlackaglnh**IWn-SoIUbl~kaglng** 

### f- Metil' Yes No Yes 

### No Plastic DYes 

# DNa If "Yes," If "Yes," f-- Glass Unit package wgi 

### lNo. per container Package woight 

### I No. percontainer f-- Paper Other (Specify) t.tocaucn of Net Contents Information 4. SI20(S) of Retail Container I

# n label 

# n Container 5. location of label Directions 

### 16. Manner in Which label te Affixed To Product ROnlabO[ , 

### f---- lithograph 

# 0 Other(Specify) 

### r-- Paper glued On material accompanying product Stenciled

0 , IV t. Contact Point (Complete items directlybelowfor Identification ofindividualto be 0 Name 

# -- Paul 

### J. Kruger Title Telephono No. (IncluclaAma Codel 6. Date Aoolication Beceived Manager. EPA Regulatory Compliance (201) 573-5329 (Stamped) Certification o_o'- I certify that the statements I have made on this form and all attachments thereto are true, accurate, and complete. I**aCknowledl~~trhat ~l~l~t:~y**  false or misleading statement may bo punishable by fino or Imprrsonment or both un r applic Ie la 2. Signature 

# lUff: 3. Title 

### d/..-... Manager. EPA Regula ory 

# q5 Compliance 4. Typed Name 

# pauli. Kruf# 5. Date Signed February 1, 1991

00

# III

February 1, 1991
Mr. Walter Francis (Actitx; FM-32) Antimicrobial Program Branch Registration Division (ID505C) U. 

### s. 

### EnvironIrental Protection Agency Crystal Mall, B.lllding #2, Room 711 1921 Jefferson Davis Highway Arlington VA 22202 RE: 

### B3.rrage Pine 

### Action Cleaner EPA Reg. No. 777-75 

### Alternate Name. Notification Deaz- Mr. Francis: '!his is 

### to inform you of an 

### alternate name for our Barrage Pine Action Cleaner (EPA Reg. No. 777-75). The alternate name is as follaws: Lysol@ Brand Disinfectant Pine 

### Action Enclosed please find conpleted EPA form 8570-1 (OPP Identifier Number 149914

- 

### Application for Pesticide Amendment) 

### irxlicating the addition of this 

### alternate name. Kindly note these charqes accortflrqfy 

### in our file. Thank you for your prompt 

### attention to this matter.

Attaclnnent

Lehn & FinkProducts 225SummitAvenue, Montvale, NewJersey 07645·1575 (201) 573-5700'-'



### Reference Number

_ 

### Input r:a.te -;;/_

File SyIlllx>l/Reg. Ii!:>. ' 

# 777-6'8: 

# rl+.:2J ill 1Icticn Code

.

# Jdd

1101 Descriptor (I\lllend/Resubmissions only) .,.',..'

_ 

## I 

## 7 (e), certification 

# o (s) 

### 'service Person 

## r7 (R) 

### N::X1-Residential

- Use Cbly 

## I 

# 7 (N) Ii!:>t-llpplicable 

## I-I Child-lJeSistant

- Packagin;; 

# 1201 Registration Type. 

# a (1) 

### oxiditicnal /') (2) 

### lInccnditicnal 

# lEI Proposed Classification. 

# 130I Final Classification 

## /' 7 (R) Restricted 

## I 

## '7 (R) lJeStricted, 

# r'7 (N) Ii!:>t 

### Classifi<!d 

# 15 I Intrastate 

### Call-In /: 

## l (Y) Yes 

## / I (N) Ii!:>



## IsoI Methoa of Support: 

# L::! (1) 

### Cite-All 

# o (2) Ii!:>t llWlicable 

## I 

## '7 (3) Ii!:>t 

### SUl::mitted 

## /, :7 (6) CWner SulJadssion 

## I'

## '7 (7) 'll:ltal 

### SUl::mission 

## I"

## 7 (8) 

### selective Met:hcrl



### losl Status:
.. .... , .......... , 1'eViewers Requested.

PM PI.

EF lXJE 

### smr' , , , , , , 'Il1\TE' , , I<E:IlJRmD

" " , , ,

, , , , , , , , , ,



# . , , , , , , , 

### . , , , ,

.' , 

### . , , " , , , , , , 

### . , , , , ,



### . . , 

### . , , , , , ,



### .....
_ 

### - 

### . 

## 1m/

# ~e 

# 1'''f'R

# r 9,Jes{ I 

# ILehn & Fink Products 225 Summit Awnue Montvale, lLJ 07645-1575 Attention: Ruth Trager Gentlemen: Subject: Lysol Brand Pre-Moistened 5athroom Touch-Ups Disinfecting Cleaning Wipes EPA Registration No. 777-68 Your Letter Dated Janua:rY 18e. 1991 The labeling referred to above, submitted in connection with registration under FIFRA is not acceptable. Note that the use direction/instructions declared on your previously accepted label dated 6/28/90, is not the same as the final labels submitted. Please note that some of the instructions were omitted. Submit five (5) copies of final labels that will conf4rm with the last accepted label. If you have any questions concerning this letter, please contact M.artha DeLaney at (703) 557-6982. Sincerely yours,

John H.

# Le~"' Product

## m~~1) Antimicrobial Program Branch Registration Division (H7505C)

### January 18, 1991 Mr. Jolm Lee Antimicrobial Pro;jraln Branch Registration Division (H750SC) 

### u.s. Environmental 

### Protection hJency Crystal. Mall, Building #2, Roam 711 1921 Jefferson Davis Highway Arlington, VA 22202 RE: Lysol Brand Pre-Moistened Bathroom Touch-{)ps Disinfecting Cleaning Wipes EPA Reg. No. 777-68
In response 

### to your letter dated June 28, 1990, enclosed. are 5 copies of final printed labeling for the above 

### rrerrtdoned product. Please include 

### this in our file. '!hank. you for, your attention to this submission. 

### Sincerely,

# ~~W',v Ruth Trager Product; Registration services Administrator Rr/lpk 

### AttachIrents

Iehn & Fink Products 225 Summit Avenue, Montvale,NewJersey 07645-1575 (201) 573·5700 

# q1

# • Fast, convenient way to sanitize -tenetseats -teieptcnes -dtaper changing counters _ Ac!;ve**(n~,ed;ent:** Alkyl (50% Cu. 40% 

### CI"

_ 10% C16} O;melhyl Benzyl Ammon;um Ch e,jdes

_ _ KEEP OUT OF REACH OF CHILDREN

_ - CAUTION: See ouler coma;n., (e, add;lienal

---

- precaul;ens and dlrectlens 10' lise. L&F PleducIs EPA Reg. LR·0005·OOO-

- Montvale. N.J. 07645 Ne.177-&8 01-ROOOS·OOOFast, convenient way to sanitize -teuet saat. ·telephones .diaper changing counters

_ Ac!;va Ingred;ent: Alkyl\50% Cu_ 40% C

### 1 ,.

_ to% C'Il}Oimethyl Benzyl Ammcnium Ch crces

_

- KEEP Ol/TOF REACH OF CHILOREN ,--:-

_

- CAUTION: $" Dulerconli;ner lor

### :':":':1;0:":':'

_

- ptlC3utions ""0 d;'ecHens Icr lise_ - L&F Products EPA Reo. LR·OOO5-OOQ

- Mentvale. N:J. 0764S No.777·58 Ot·ROOOS·OOO- 

# .

# -1" 'Ill, ClHlvtftllnt

## we, todun and UJIlliz. MId yau 1IMl. Ust

# "*" onbaltIroom 'Ullle

..

# '=''"11 and l.ltpllon

.. kI mill'.

_ fIIlMnlIlI. llU IlIIloM. *Ports. itIt Iftd JIrf

.**~r.t'J'~J".o** --. llIlconcn

_,. •••i_.._ 

## ..-III.

..1IIoIJI. 10CUM

_ $MI11lf _IIlJHOOOWIIIIlI:I tlUllllIa.1IltUlOIIIll1OUT 5Ql$. ""'.

_

_ 10

__ __ "
..**~~-.** 

# I_

..... JlIQI/IDlMfIlMQUft1WNlllli1O*-_IICaUTIt-a CIUllOlt

.._ _ _ ..._ ....



## _ ....-III_ 

## -.--.y

__......,. -.

_ _ _ _ _ CliIi

. 

# --

. 

# ==='"':='===.'-*'- I

.-r-:



# --\"-



# _ ...

# _-



# - .........m. ._ 

# ......

# _.- ".-

# .Ilil!II'~II. II! 

# .. !

.... 

# ------



# + '-:=-.....=:.=.:::.::1:::



# ----_. ::;.1-" 

### o -" 

# x-.:J , S' Of'EPA REG. NO. NO NEW LABEL NEW LABEL ATTACHED SUPPORT BR. PM 

# Jd. ATTACHED NOTIFICATION

# t&..t~ TO: FROM:

COMPANY NAME

__ NEW CSF ATTACHED

*******************************************************************
THIS IS AN ADDITIONAL BRAND NAME THIS

__

# 0~IS IS A CSF PERMITTED UNDER PR NOTICE 88-6 IS A LABEL CHANGE PERMITTED UNDER PR NOTICE 88-6

******************************************************************

·FILE IN JACKET __ /THIS 

# :7 WAS SENT TO SIG FOR CODING AND/OR MICROFICHINGForm Approved OMS No 2070-0060 Approval expires 6 30 90 Please read In51r ctrcns on reverse before eompleting form

EPA Form 8570-' (Rev.4-88) Previous edltlons are obsolete. 

## " , - United States Environmental Protection**~ency** OPP Identifier Number Office of Pesticide PD8rams (TS·767 

# &EPA Washington, 20460 

# 149902 Application for Pesticide: 

# 51 Registration x Amendment



## - t. Company/Product Number 2. Dafe 3. Product Manager 4. Proposed Classification 777-68 10/29/90 John Lee (PM-31) 

### [Xl'( I

# n restric- X General ted 5. Name and Address of Applicant (Include ZiP Code) L&F Products 225 Summit Avenue Montvale, 

### NJ 07645


# n Checkif this Is a new address - 6. Product Name 

## -

Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes



# . . - t. Subject 

# n final prlnfed label 

### fXl Other (explain below) Date of Letter**n-~~submissio~** A, NOTIFICATION

Alternate word "facility" after public "places" on back label for box, pouch or canister.

Section III t. Material This ProductWill Be Packa ed In 2. Typo of Container Child-Resistant Packaging Unit Packaging Water-Soluble Packaging



## - Molal 

# nV" nNO nV" nNo Plastic Dves 

# DNo If "Yes." If"Ves;



## - 01.,. Unit package wgt 

### !No.per container Package weight 

### INo. per container


## - Paper Other (Specitj)

. Location of Net Contents Information 4. Size(s) of Retail Container 

# In Label 

# n Container 5. Location of Label Directions 6. Manner in 'Mlich Label Is Affixed To Product 

# = Uthograph 

# o Other (Specify)

## R~nLab81 _ Paper glued On material accompanying product Stenciled ,IV



## -- t. Contact Point (Complele items directlybelowfor identification ofindividualto be
, ,", Name Ruth Trager
Title Technical Support Specialist Telephone No. (IncludeArea Code:' 6. Date Apptication Received 201-573-5328 (Sta,r,pdJ) 

### cerenceuen 

### ....

# - I certify that the statements I have made on this form and all attachments thereto are true, accurate,**~:l'j** complete. I acknowledge fhat any knowingly false or misleading statement may be punishable by nneer impnsonment or both under epplicable law. 

# 2S;9';{ ir\l\{\c>f\) 3. Title Technical Support 

### I Specialist f 4. Type Name 

# 0 5. Date Signed

- 

### -- Ruth Trager

## lo/~9Ao

--BOX (POllCIIl (CANISTER) IAI!EL



# * New LYSOIJ!> Brarrl Pre-M:>istened Bathroan Tooch-Uj:s 

### Disinfec:t.in3 Cleaning Wipes
Ready 

### to Use Travel 

### Size (Pack) 

### o::m:EmS 16 Individually 

### wrawe<i Pretoc>istened Tco;elettes (8" X 5 3/4") (Box) 

### or 20 Pre-M:>istened Tco;elettes (8" X 5 3/4") (""->ch) 

### or 25 Pre-M:>istened 

### Wipes (7 1/2" X 10") (canister)

JDSPITAIS NURSING JmES CLINICS I:>EtmU. OFFICES SOIOOIS VErllRINI\RY OFFICES OCMI.J:NG

# = IKJI'E[S I1ESTAllRANl'S mY CARE 

# = lliYSICIAN OFFICES IlEAIlIH CIlJBS AMElJIllllCES KENNELS AIRroRTS MALLS G1IS STATIOOS RJ!lLIC REST ROCMS RJ!lLIC TE:rEm:mS DIAPER OWlGING roJN1'ERS quick and easy way 

### to clean and 

### disinfect (sanitize) Toilet 

## seats Kitchen, Bathroans laundry Roan Walls, Floors 

### Diaper Clanging Cotmters 

### Toilets, Sinks shccera, iUbs 

### Tile, Enamel, Porcelain Garbage 

## cans, Diaper Palls Nursel:y 

### Telepmnes cabinets storage & 

### Pet Areas

and other hard surfaces anywhere 

### you travel. Quick • Convenient • l'brtable



# *

Will only be used 

### for 6 nxmths fran date 

### of intl:OO.uction.

',' L.. ." LAB8..I'''' ,c_.**_~_"".i:;:O**

PER PR NOTiCE ee-a

## DATE·~O-2-
roll: (POUCH) (CANISTER) Ll\BEL mJNl' 

### lcmr.l

Ready 

### to use, convenient; the quick ani easy way 

### to 

# clean ani 

### disinfect (sanitize) 

### toilet seats an:i other hanl 

### .sur-races,



### canister Only Cleans 

### Disinfects (sanitizes) Hard SUrfaces '!he 

### quick, easy Way 

### to clean surfaces and kill (household) 

### germs L--

_

A=vE INGREDIENr:**~l (50~_C14'**  40% C12, 10% C16) D:unethyl =yl AlTnronIUln Oll.orldes INERT INGREDIENTS: TOI'AL 0.28% 99.72% 100.00% KEEP OOT OF REAm OF CHIII:ilEN CAUI'ION: 

## see back panel for 

### additional precautionary stateloonts. Dces 

### not include 

### weight of dJ:y 

### wipe. EPA Reg. No. 777-68 EPA Est. No. 777-IL-1, NJ-2; 52631-NJ-oOl 

## (see Bottom)


# /03Travel 

### size -3-


## rox (FCUCH) (CANISTER) LIIBEL BACK Pre-Moistened Batlu:oan Touch-Upo 

### Disinfectin;J Cleaning Wipes fast convenient way to clean arxl 

### disinfect (sanitize) haJ:d 

### surfaces anywhere 

### you travel. 

### Use them 

### on batlu:oan 

### surfaces, toilet seats 

### am. telet=hones in 

### malls, restaurants, gas 

### stations, aiIports, 

### rest stq;:s, arrj' 

### pmlic place (facility) where 

### genns or bacteria 

### may be a ccrcern.

fast convenient way to clean end 

### disinfect (sanitize) haJ:d 

### surfaces. Use them 

### in toilet areas, urxier sinks, 

### sick roans, shc:Mers, 

### bath 

### tubs, patient 

### chairs, examination tables, garl>age pails, operatories, stretchers, laboratories, cuspidors, door han:lles, wheel 

### chairs, 

### ccorrtera, a:rxi other 

### places where genns or 

### bacteria may 

### be. a concern. 

### NfM' Lyscl" Brand Pre-Moistened Batlu:oan Tooch-Upo 

### Disinfectin;J CleaninJ Wipes are the 

### ccnvenient way to clean and 

### disinfect (sanitize) haJ:d 

### surfaces.

For general 

### cleaning and 

### disinfectin;J (sanitizing) haJ:d 

### nonporous 

### surfaces•


### canister Only 

# • NfM I!fscl" Brand Pre-Moistened Batlu:oan Touch-Upo 

### Disinfecting Cleaning Wipes are the 

### ccnvenient way to clean and 

### disinfect (sanitize) your hoosehold surfaces. Each 

### premoistened, di.sp:>sable 

### wipe 

### is treated 

### with a special 

### cleaner that actually kills genns - even the germs 

### that cause cdcc-s - 

### wherever you 

### use 

### it. No bottles, no 

### spcrqea, no 

### ness, Effective 

### disinfectin;J (sanitizing) has 

### never been 

### faster or easier. Unplug small electrical 

### appliances before cleaning. Not reo::mrerxIed for polished or bare wood 

### surfaces. 

# • Will only be used 

### for 6 IIXJnths 

### fran date 

### of introduction.-4- 

## oox (FaJCH) (CANISTER) IABEL 

### Bl'GK (CI:m.) 

### Directions for use: It is 

### a violation of federal 

### law to 

### use 

### this prcx:1uct 

### in 

### a 

### manner 

### inconsistent with 

### its lahelin:J. 10 CLE1lN AND Sl\NITIZE lIl\RD SURFl\CES (=mIm 10= SElITS): Use 

### a fresh 

### towelette 

### to 

### wipe surface. 

### Flush or 

### toss dirty 

### wipe away. 

### Allow surface 

### to 

### remain wet 

### for 30 seconds, 'Ib 

### sanitize heavily soiled. surfaces, 

### repeat with 

### a clean 1:cMelette. 10 CLE1lN AND DISINFECT 10= SEM. Use 

### a fresh 

### 1:cMelette to wipe toilet seat. Flush dirty 

### wipe a>laY. 

### Allow surface to 

### remain wet for 10 

### nrirurbes, 'ro 

### disinfect heavily soiled surfaces repeat with a clean 1:cMelette. 10 CLE1lN AND DISINFECT cmlER Illilll1«:X:1l SURFl\CES. Use 

### a fresh 1:cMelette accordirq to 

### directions above. 

### Flush or 

### toss dirty 

### wipe away.

canister Only 

### Pull 

### up tab 

### am 

### rencve large 

### cover. Insert 

### trian::JUlar loop through 

### slits 

### in 

### cavex, Thread first sheet 

### in 

### center of roll through 

### loop. Replace cover', 

### Pull loop back through 

### openinq, Pull each 

### sheet 

### up am slightly to the side. 

### Always snap lid 

### securely shut between uses 

### to prevent rrolsture loss.

Pouch Only 

# I I\'!el back the front 

### labal slowly. Rem:we towelettes 

### as needed. Reseal pouch by 

### finnly ronning 

### thumb aver the 

### labal. Lysel" Ilranl. Pre-Moistened Bathroan Touch-lJps 

### Disinfecting Cleaning 

### Wipes meets efficacy standards 

### for (hospital type) 

### disinfectant (sanitizing) wipe. Kills Influenza A2 

### (Japan) am Herpes 

### Slnplex Type 1 

### viruses am 

### streptcxxx::cus faecalis 

### germs. Inhibits rrold am mildew 

### in danp 

### am misty 

### places. Kills 

### Human IImnunodeficiency 

### virus Type 1 (lUV-1) (AIDS 

### Virus) on precleaned 

### environmental. surfaces/ctljects previoosly soiled with bloocljhody fluids 

### in health 

### care settings 

### or other settings 

### in which there 

### is an expected 

### likelihood of soiling of 

### inanilnate 

### sur-races/cojecta with blood or body 

### fluids, am 

### in which the 

### Sl'tiac:es/ 

### cojecta likely to ba 

### soiled with blood or body 

### fluids 

### can be 

### associated with the potential 

### for t.ransrni.ssion of human i.mmunc:rleficiency viros 'IyPe 

### 1 ar:v-l) 

### (associated with 

### AIrs) • Special 

### Instructions for Cleaning and 

### Decontamination Against lUV-1 

### of SUrfaces/Cbjects Soiled with Blood/Body Fluids. 

### Personal Protection: When 

### handling items soiled with blood or Jx.dy 

### fluids use 

### di.sp;:sable latex glOV'es, ga;.ms, nasks 

### or eye 

### coverings. Cleaning: Procedures: 

### Thorwghly clean blood am other body 

### fluids fran sorraoes and 

### objects with a 

### wet 1:cMelette. Use 

### a second 

### wet 1:cMelette to disinfectzr:t. CQntact Time: 

### Allow to 

### starn 10 

### mimrtes, Disposal 

### of Infectioos Materials: Blood am other body 

### fluids should be

. 

# s: autoclaved and disposed 

### of acccrdinq to local regulations for infectioos 

### waste i /) A-l.---...., !',J**.........,.~.** I

### -5-


## rox (IalCHl (C1\NIS'I'ERl 

### tABEL Bl'.CI<; (<Xm.l
rnEC1\l1I'IONARY STATmENI'S HAZ/IRDS 1:0 HUMANs AND lXtIESTIC JI.NIIIJMS 

### caution: May cause eye irritation. Avoid 

### contact with· 

### eyes. wash hands after 

### use. STATEMENT OF FRACl.'ICAL In 

### case of eye 

### contact, IMMEDIATELY flush 

### eyes thorooghly with water, 

### reecve any 

### rontact lens, arxl 

### conti.rnJe to 

### flush eyes 

### with 

### plenty of water 

### for a least 15 m:imrt:es. 

### call a physdcdan if 

### irritation 

### persists.

S'IORllGE AND DISrosAL 

### storage: store unopened 

### package in a cool, dry 

### place. 

### Container Disposal: Put 

### empty 

### box (pouch) 

### am envelopes in trash 

### collection.

Canister Only S'IDRAGE AND DISrosAL 

### storage: store in 

### original container 

### in 

### areas inaccessible 

### to small children. store canister 

### in a cool place. Disposal: Do 

### not reuse empty container. Wrap 

### am put 

### in trash.


### Manufactured by 

### I.ehn & 

### Fink Products Montvale, New 

### Jersey 07645.NEW LABEL ATTACHED NO NEW LABEL PPORT BR. ATTACHED NOTIF C**TIO~fl** TO: 

### PM_-t'fA-"--

# fI~ FROM: 3kEG.

EPA REG. NO. COMPANY NAME

__ NEW CSF ATTACHED

### *******~*'*********************************************** * * * * ****** * ****** *** THIS IS AN ADDITIONAL BRAND NAME THIS IS A CSF PERHITTED UNDER PR NOTICE 88-6 THIS IS A LABEL CHANGE PERMITTED UNDER PR NOTICE 88-6

******************************************************************

## ~HIS WAS SENT TO

_____ 'FILE IN JACKET SIG FOR CODING AND/OR MICROFICHING



# (/

,

# .

.. 

# , L 

### ."

' 

# /01Please read inttrtlClions and notice on reverSf \<\6 No 2070-0060 Approval expires 6-30-90 

# &EPA 'ore completing form Form Approved Unaed Stales Environmental Protection AQency Office of Pesticide Programs (1"5-767) Washington, DC20460 

### Application for Pesticide: 

# 0 Registration 

## Ii]Amendment QPP Identifier Number 

# 139046

1. Company/Product Number 2. Date 

### 777-68 7/16/90 5. Name and Address of Applicant (fncfudeZIPCode) Lehn 

### & Fink Products 225 Summit Avenue Montvale, NJ 07645


# n Check If this is a new address 3. Product Manager 

### "t.--" J. Lee '/ 4. Proposed Classification ,..:.,' -;'-"'RestricIX I General I Ited

6. Product**Na~e** Lysol Brand Pre-Moistened Bathroom



# . ,,,. Touch-Ups Disinfectina Cleanina Wine
1. Subject I**ri~esubmission** 

# nrnal printed label ,

# .•. I;l Other (exo/afn below) Dale of Letter
NOTIFICATION Alternate name of: LysOl(R) Brand

### Saniti~ing Wipes
Section III t. MaterialThisProductWill Be Packa Child-Resistant Packaging od 10 Unit Packaging



# ny" hNO If"YeS," Water-Soluble Packaging 

# ny" nNO If"Yes," Unitpackage wgt 

## INo. percontainer Package weight 

## INo. per container 3. Location of NetContents Information 4. Size(s) ofRetailContainer ,nLabel nContainer 5. location oflabel Directions**ran:~~~::~Ch** label Is**AffDd~~;r~:~:~)** On label 

### r-- Paper glued n,On material accompanying product Stenciled Sectton IV t. ContactPoint (ComplBteitems direcflybelowforidenfificafion ofindividualtobe Name Ruth Trager Title Technir.al RU 

# .., 

# .. 6. Date App:icalion Received (S'amped) Certification I certify that the statements I have made on this form and all attachments thereto are true, accurate, ",r,d complete. I acknowledge that any knowingly false or misleading statement may be punishable by fine fir Imprisonment or both under applicable law.

. 2. Signa Iff$\, 3. Tille. '"
4. Typed Name 

## 0 5. DateSigned Ruth Trager EPA Form 8570-1 (Rev.9-88) PrevIous editions are obsolete. 

### 7/16/90 

# 1,.(

# III

July 16, 1990

Mr. John Lee (PM-31) 

### Antimicrobial Program Branch Registration Division (H7505C) u.s. Environmental Protection Agency crystal Mall, Building #2, Room 711 1921 Jefferson Davis Highway' 

### Arlington, VA 22202 RE: LysolR Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes EPA Reg. No. 777-68 Dear Mr. Lee:

.. "". R 

### ThlS 15**to~n2~~~Y?YOU** 

### of 

### an alternate name for Lyso! 

### Brand PreMoistened 

### Bathroom Touch-Ups Disinfecting Cleaning Wipes (EPA Reg. No. 777-68). The alternate name is as follows: 

### Lyscl(R) Brand sanitizing wipes Enclosed is EPA Form 8570-1, Application for Pesticide Amendment, OFF Identifier Number 139046, indicating the addition of this 

### alternate name. Please note this change accordingly in our file. Please don't hesitate to call me at 201-573-5328 

### if you have any questions. sincerely,

# ~~ Ruth Trager Technical Support Specialist RT/ca 

### enc.

Lehn& FinkProducts 225 SummitAvenue, Montvale, NewJersey 07645-1575 (201) 573-5700 

# j()9" .ord Number 

# -::J 

# r,;

# ;9f'(,

/ Input Da.te . L-/



### 12s[**~op::>sed** Classification: 

### [301 Final Classification 

# r 7 (2) Unconditional 

### service Person Certification



### N:Jn-Residential Use Only 

## 17 (N) Not-Applicable 

## 17 (e) 

## 17 (S) 

## 17 (R) 

# ill Action OXle

Child-Resistant Packaging PM 

# 5/

17 (N) No Intrastate Call-In 

## 17 (y) yes Descriptor (Amend/Resubmi.asdons only) 

# 1101 15 I 

# 1201 Registration Type, 

## 17 (1) O::nditional File SymOOl!Reg. No,

# ~l=l-bf

17 (R) Restricted 

## 17 (G) General



# 180I Method of Supporb 

## 17 (1) Cite-All 

## 17 (2) Not lIfplicable 

## 17 (3) Not SUbmitted 

## /7 (R) Restricted 

## 17 (N) Not Cl.assified EPA Received Dated: 

# 01 YR 

## 17 (6) Owner Submission 

## /7 (7) Total SUbmission 

## 17 (8) selective Method 

### j40j tate Received b I?!-h

" 1

>0

# crllt/fD

CODE 

# J7 V/f/J 7 D1\TE 

### Reviewers Requested: SENr RD PM PL CH EF <'--:::: 

## 11081 Status: IXJE D1\TE D1\TE REIURNED RESPONSE RESPONSE



### ITISj FINAL Response 1"1

- ACrION Cede

# --+-+-
7S-D1\Y RESPONSE DUE DATE, 

# Q (Y) Yes

### .JUN 28 1990

Lehn & Fink Products Group Division of StArling Drug 225 SUIllDlit Avenue Montvale, N.J. 07645 Attention: John J. DoiIlanski Director of Toxicology Product Name: Lysol Brand Pre-Mo1.stened Bathroolll. Touch-Ups Disinfecting Cleaning Wipes Registration Number 777-68 Application"Dated 2-t2-.90

_ '. ,:,' The labeling referred to above, submitted in connection with registration under FIFRA, is acceptable provided that you: 1. product Make the labeling changes listed below before for shipment bearing the amended labeling: you release the

a. Changli "Kills sold and mildew· to read "Inhibits mold and mildew". b. Above "SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION

••• OJ a statement should be included KILLS HIV ON PRE-CLEANED ENVIRONMENTAL SURFACES/OBJECTS PREVIOUSLY SOILED WITH BLOOD/BODY FLUIDS in health care settings or other settings in which there is an expected likelihood of soiling of inanimate surfaces/ objects with blood or body flUids, and in which the surfaces/ objects likely to be soiled with blood or body fluids can be associated with the potential for transmission of human immunodeficiency virue Type 1 (HIV-1) {associated with**~DS}.** c. On the front panel, place the signal woxd ·CAUTION· directly below the Child Hazard warning Statement. SBS19:I:DeLaneY:LL-10:KENCO:6/19/90:7/19/90:dg:sw:vo:ek:d9-2- 2. Toe submitted**Vi.ruc~dal,** Fung.1.C1.da.l and Sanitizing efficacy data. have been reviewed and are acceptable. 3. The Agency ecxncvj.edcee the cnenqe in your product name from "Lysel Brand Pre-Moistened Touch-ups Disinfecting Cleaning Wipes· to "Lysol Brand**Pre-Moist~ned** Bathroom Touch-ups Disinfecting Cleaning Wipes." 4. Submit five (5) copies of your final printed labeling before you release the product for shipment. Your release for**shipm~t** of the product bearing tne amended labeling constitutes acceptance of these conditions. A stamped copy of the labeling is enclosed for your records. If you have any questions concerning this letter, please contact Martha DeLaney at (703) 557-6982. Sincerely yours,

John H.**L'_;;tl~** Product Ma Antimicro al Program Branch Registration Division (H750SC)ACmE 

### Dl:Jl"lE1lllNr. AlJ<yl (sot C14' 40% 

# Cu' lot C16) 

### Dimethyl Benzyl 

### A!IIlXrlium Ollorides . 0.28%

99.72%



## • ..rUN 2 8 1990



### see cut:er CCI'ltajr,er 

### tar additiCl1al 

### precautions and 

### direc::tialS 

### tar use. a:vI'l\INER DISPOSAL: DiscaJ:d t!Il¢:Y 

### enveJ.c:pe 

### in trash
EPA !leg'. No. 777-68 

### Est. No. 

### 52631-NJ-OOI Net Q:r1tents: Lehn & Fink, 

### !'i:lrlt:vale, NJ 07645-2-
BOX (POUGH) (CANISTE!lJ 

### LABEL FRONT (CQNT.)


### ALTERNATE LANGUAGE Ready to use, convenient; the quiCk and easy way to clean and disinfect (sanitize) toilet seats and other hard surfaces.



### canister 

### Only Cleans 

### Disinfects**(Sanitize~J** Hard Surfaces The quick, easy way to clean surfaces and kill (household) germs

'------- <



### ACTIVE INGREDIENT: Alkyl (50% C14, 40% C1 2, 10% C1 6) Dimethyl Benzyl Ammonium Chlorides


### INERT INGREDIENTS: TOTAL 0.28%

99.72% 

### 100.00% KEEP OUT OF REACH OF CHILDREN

Does not include weight of dry 

### wipe. 

### EPA Reg. No. 777-68 EPA Est. No. 777-IL-l, NJ-2; 52631-NJ-00I
, 

### CAUTION See back panel 

### for additional 

### precautionn:::-r statements. 

### (See Bottom)**.j;:~1 ~;.­**  inEPA k,



### 'JUN 2 8 1990 

# /1'1

### Travel Size BOX (POUCH) (CANISTER) LABEL BACK

-3-



### New*LYSOL R Brand Pre-Moistened Bathroom Touch-Ups 

### Disinfecting Cleaning wipes 'The fast convenient way to clean and disinfect (sanitize) hard surfaces**~nywhere** 

### you travel. Use them on bathroom surfaces, toilet seats and telephones in malls, restaurants, gas stations, airports, rest stops, any pUblic place where germs or bacteria may be a concern.

ALTERNATE LANGUAGE 

### The fast convenient way to clean and disinfect (sanitize) hard surfaces. Use them in toilet areas, under sinks, sick rooms, showers, bathtubs, patient chairs, examination tables, garbage pails, operatories, stretchers, laboratories, cuspidors, door handles, wheel chairs, 

### counters, and other places where germs or bacteria may be a concern. New* LysolR Brand Pre-Moistened Bathroom Touch-Ups Oisinfectine Cleaning Wipes are the convenient way to clean and disinfect (sanitize) hard surfaces.

Canister Only 

### For general cleaning and disinfecting (sanitizing) hard nonporous surfaces. New* LysolR Brand Pre-Moistened Bathroom Touch-Ups DisinfectJ.ng Cleaning Wipes are the convenient way to clean and disinfect (sanitize) your household surfaces. Each premoistened, disposable wipe is treated with a special cleaner that actually kills germs - even the germs that cause odors

- wherever you use it. No bottles, no sponges, no mess. Effective disinfecting (sanitizing) has never been faster or easier. Unplug small electrical appliances beforu cleaning. Not recommended for polished or bare wood surfaces.

* Will only be used for 6 months from date of intrOduction. 

## // ",
/ "j

### -4- ACiJEPT.c:D with C03I:;1SNTS i:in,EPA Lo:t{:L"**Dl",t;~h,** 

## Jun 2 

## a 1990

BACK (CONT.) BOX (POUCH) (CANISTER) LABEL ,.., "Vndcr tho Pc,!>':)**!i1~T'** ,.,.:'
..... '"**~'<t'Llllgidde,** H11J**f~';,/**..**l.~j~;,;ci~~·~\'~~** \l**~-all,** amonded, Ior th:: pesUdJfr r"fegiflwrod-lmdci" EPA:fjt:CS"' :No•



### .'**"~._._** 

### 777- 

## ? Directions for use: It is a violation of federal

### l~J;~s -, .,,-........ product in a manner inconsistent with its labeling. TO CLEAN AND SANITIZE HARD NON-FOOD CONTACT SURFACES (INCLUDING TOILET 

### SEATS): Use a fresh towelette to wipe surface. Flush or toss dirty wipe away. Allow surface to remain wet for 30 seconds. To sanitize heavily soiled surfaces, repeat with a clean towelette. TO CLEAN AND DISINFECT TOILET SEAT: Use a fresh towelette to wipe toilet seat. Flush dirty wipe away. Allow surface to remain wet for 10 minutes, Te disinfect heavily soiled surfaces repeat with a clean towelette. TO CLEAN AND DISINFECT OTHER BATHROOM SURFACES: Use a fresh**tow8~tte** 

### according to directions above. Flush or toss dirty wipe away.

canister Only

Pouch Only Pull up tab and remove large cover. Insert triangular loop through slits in cover. Thread first sheet in center of roll through loop. Replace cover. Pull loop back through opening. Pull each sheet up and slightly to the side. Always snap lid securely shut between uses to prevent moisture loss.

Peel back the front label slowly. Remove towelettes as needed. Reseal pouch by firmly running thumb over the label.

fluids regulations 

### ! LysolR Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes meet efficacy standards for (hospital type) disinfectant (sanitizing) wipe. Kills mold and mildew in damp and musty places. Kills Human**~mmunodeficiency** 

### Virus Type 1 (HIV-l) (AIDS Virus) on precleaned environmental surfaces/objects previously soiled with blood/body fluids. special Instructions for Cleaning and Decontamination Againsr HIV-l of Surfaces/Objects Soiled with Blood/Body Fluids. Personal Protection: When handling items soiled with blood Jr 

### body fluids use disposable latex gloves, gowns, masks or eye coverings. Cleaning Procedures: Thoroughly clean blood and other body fluids from surfaces and objects with a wet towelette. Use a second wet towelette to disinfect. Contact Time: Allow to stand 10 minutes. Disposal of Infectious Materials: Blood and other body should be autoclaved and disposed of according to local for infectious waste disposal.-5-


### BOX (POUCH) (CANISTER) LABEL BACK (CONT.)
PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS Caution: May cause eye irritation. Avoid contact with eyes. Wash hands after use. 

### STATEMENT OF PRACTICAL TREATMENT In case of eye contact, IMMEDIATELY flush eyes thoroughly with 

### water, remove any contact lens, and continue to flush eyes with plenty of water for a least'IS minutes. call a physician 

### if irritation persists.

STORAGE AND DISPOSAL Storage: store unopened package in a cool, dry 

### place. Container Disposal: Put empty box (pouch) and envelopes in trash collection.



### Canister 

### Only STORAGE AND DISPOSAL 

### storage: store in original container in areas inaccessible to small children. Store canister in a cool place. 

### Disposal: Do not reuse empty container. Wrap and put in trash.

,**--~-.** __ . 

### ......,..,.**-,.~"** Manufactured 

### by Lehn & Fink Products 

### Montvale, New Jersey 07645. AL"G';PTED with COMMENTS



### .. WE.P4l.ctt,rDatc4:



### JUN 2 8 

### 1990Pink PM/RMjDC/ r::....... _**o~** •..

_ .......**,~~""** _ .**.:~** .. WhIW· Data Cooro'rnator v..rr"

..,_**n~** ... D""
....**""~...,..,r;,,"** EPA Form 8570-17 (R<lv. 11-88)**D.~** .. ;....**,~** •.-li,;,,""

..... "

...",,1"1'" Use this torm forindividualstudies & to submitPf'sticid6 BpfJlFcations. , ;;: United States Environmental Protection**~ency** Pack Number Date Rec6ivod cr: Office of Pesticide Programs 

# .. Washington, DC 20460 ',', 

# SEPA Data Review Record**:~!** Confi<jonthlBusiness InfortrlatJon
- Do8s notamtaln National&c1.JrityInformation (£.0. 12065)



### . .
1

# "'t~~":!' !1;r<i/i

# I fJ-e
-All {hi

# 4<.01**k~",,-** 

# ?:**~IName** -u.n r 

# " 2. 3. <I.Action 5. MAID/ 

### / 6.



### . . r.orl • 

# 777-(,'\/ ;<:(/6

.

7. geterence No. 

# ;W;:Ng. Prod/Review ¥gr/OCI to. PM/AM Team No 11.Oate EO

# ~6Jl!'o 13. Date Returned 

# .s.. 3/**~ROlJlEAD**

# 9~/;>; tf/;-i7fO Instructions

# ~}L**r~(.JZ..u**

# ~'<>-I 

# dz 

# 1:1Le

. Thfs Section Applies to ReviewofStudies Only t4. O1eckApplicabl6 Box 15. No. of Individual Studies i

# 'Fl' Adverse 6(a}(2) Data {405} 

# R Generic Data (ReregistIaUon)(650l Submitted Special gevrew Data (8701 Product scecmc Data rRereoistrationlf655l t6. Have any of the above studies (in whole

### orm part) been previously submitted for roview? 

# - 17. Related Actions DYes (pl6as6 identifyrho StvdY(HlS)) 

# 0 No



# ". To T we of Review t9. Reviews Also Sent to 20. Data Review Criteria Science Analysis & Coordination f-- SAC 

# D PC A Policy Noto No. 31 Toxicology/HFA i- TOX/HFA Pl 

# P .> HED Toxicology/IR

_ TOX/IR 1 .. datawhich meet 6(a)(2} or

,.... meet3(c)(2)(B)flagging Dietary Exposure f- DEB 

# § EA criteria. Nondietarv Exposure NDE AC Ecological EHoC1S 

## IEEB 8A 

# P 2 = data of particularconcern EFED Environmentat Fate & Groundwater from regislraUon $tandard Sp&eial Revillw**~EFGWB** SRRD Reregistration '- 

# b 3 = data necessaryto determine Generic Chemical Sucocrt SR tiered tes1ing**reQuiremen~s** Insecticide·Rodenticide I- RER Fungieide.Horbicid<l GSC 8. Section 18 f- RO 'Y. Antimicrobial '- 

# p t

.. data in support of section 3 Product Chemistry in lieu of section t8 r- IR Precautlonarv Labelincr FH EconomicAnalysis f- rw. pnen Ingredients 8EAD Analytical Chemistry t '" data In support of conlinuec 8iol001cnl Analvsis use of ust 1 inert 

# o Confid<lntial**Stn~rent** ot Formula :sJ 

# o Label Attached 

# liZ (EPA Form 8S7Q-4 Attached (Trado Secrets



# -

### EFFICACY EVALUATION AND TECHNICAL MANAGEMENT SECTION EFFICACY REVIEW - I 

### Antimicrobial program Branch
IN 02-15-90 OUT 05-02-90

Re vi ewe

### d By_-"''''-'''-''--''--'---'''-''-''-''''-''''-''--

__

### --''-''-''c=..-''''-'==''-''

_ 777-68 EPA Reg. No. or File Symbol**-'-'--'-~-"-** _ 

### None EPA Petition or EUP NO, -"""'-''-

_ 

### 04-27-90 

### Date Division Received**~~~~~** 

### __ Type product(s) Hospital Disinfectant/Impregnated Towelette Data Accession NO.(S) 414597-01-03 

### Product Mgr. No. PM 31 (Lee) Product Name(s) Lysol Pre-Moistened Bathroom Touch-Ups Disinfectant 

### Cleaning Wipes Company Name's)' Lehn & 

### Fink Products Group, Sterling Drug, Inc. 

### Submission purpose Additional Virucidal, Fungicidal & 

### sanitizing Efficacy Data 

### Single Use Disposable Impregnated Towelette Active Ingredient(s): % 

### Alkyl (50% Cl4' 40% Cl2' 10% Cl6) 

### dimethyl benzyl ammonium chlorides 0.28%

### 200.0 Introduction 200.1 Uses: Refer to the most recently accepted label dated 09-08-89. 200.2 Background Information: The submission received 02-15-90, is a resubmission with amendments to the label. Efficacy data and new labels provided. 201.0 Data summary (MRID Nos. 414597-01-03) 201.1 Brief Description of Tests:
a. Reports**o~** 

### Virucidal Tests by: Bonnie J. Bowdon, Southern Research Institute 2000 Ninth Avenue'south Birmingham, Alabama 35255 b. Reports of sanitizer Tests by: Joseph Rubino & Janice Bauer Lehn 

### & Fink Products Group Microbiology Laboratory 225 Summit Avenue Montvale, NJ 07645
c. Reports of Fungicidal Tests by: Joseph Rubino 

### & Janice Bauer Lehn & Fink Products Group Microbiology Laboratory 225 Summit Avenue Montvale, NJ 07645 201.2 Test Summaries:
a. Virucidal Tests 1. Method: U.S.E.P.A. Pesticide Assessment Guidelines, Subdivision G: Product Performance, 1982, section 91-30, 

### pp. 72-76. 2. Test Virus: Human Immunodeficiency Virus, HTLV-IIIRF strain of HIV-l 3. Virus Inoculum 

### & Drying Procedure: 0.2 ml of virus pool in RPMI-1640, containing 20% (v/v) fetal calf serum was dried on the bottom of glass petri dishes (28 cm2) at room temperature (approximately 23°C) until visibly dry (approximately 45 min.) and then incubated at 35-37°C in a dry air oven for an additional 30 mins. 

### 4 . Exposure: Dried virus films were wiped with with 

# I 011 the pre-saturated pad for 1 minute and allowed to

### remain in contact for a total exposure period of 10 minutes at approximately 23°C. After 10 minutes, 2 ml of complete RPMI 1640 medium containing 10% fetal calf serum was added to the bottom of the dish was scraped with a rubber policeman. An aliquot of virus-disinfectant mixture was immediately added to a Sephadex column for separation of virus from disinfectant by gel filtration. 5. Test Samples: Lot No. H6-256A and H6-2568 6. Use-Dilution: None; pre-saturated pads 7. Host Infection 

### & Virus Assay: MT2 cells were treated with polybrene for 30 minutes at 37°C, collected by centrifugation and plated in 96-well culutre plates at approximately 1 x 102 cells per**wel~** 

### in 0.15 ml of medium. Dilutions of each of the test and control groups were inoculated (0.05 ml/well) into four replicate cultures of MT2 cells and the cultures were scored for lytic cytopathic effects (CPE) after 7 days of incubation at 37°C. 8. Neutralizer/Diluent: sephadex gel filtration was employed for neutralization and filtrates were collected and diluted ten-fold serially for assay of infectivity. 9. Results: Refer to attached tables. 10. Conclusions: The efficacy data meet the requirements of the product against HIV-l in the presence of a moderate amount of organic soil undiluted with a contact time of 10 minutes at approximately 23°C. b. Fungicidal Tests 1. Method: EPA Efficacy Data Requirements for Single-Use Impregnated Towelettes for Hard Surface Disinfection and acceptable modifications of the A.G.A.C. Germicidal Spray Test 14th Ed., 1984, 

### pg. 71. 

### 2. Modifications: 5% blood serum
sample 851/1 851/2 

### 3. Samples: Date Made 01/14/88 01/14/88 

### Date Tested 08/30/88 08/30/88 

### Data References JMB-6-199 DA-2-101 

# jell

### 4. 

### Di Iu ticn: Undilu ted 5 . 

### Exposure: 10 

### minutes 6. 

### Subculture Medium/Neutralizer: Letheen Broth 

### 7. Incubation 

### of subcultures: 10 days 

### for 30°C 

### 8. 

### Test Organism: 

### Test organism Trichophyton mentagrophytes 9. Test Results: ATCC No. 

### 9553 Phenol Res. 

### 1 :85



### Sample Slide 

### Expressed Liquid 

### from Towelettes 

### 1st Sub. 2nd 

### Sub. Organism 851/1 851/2 0/10 0/10 0/10 0/10 0/10 0/10 

### T. mentagrophytes 

### T. mentagrophytes 10. Conclusions: Results show satisfactory performance of the product against Trichophyton mentagrophytes when used undiluted for a contact time of 10 

### minutes.


### c. The submitted for Aspergillus niger are not summarized in this report since claims against this organism are not considered to be related to human health. d. 

### sanitizer Tests 1. 

### Method: Non-Food 

### EPA Sanitizer Test Contact Surfaces for Inanimate
2. Modifications: 5% blood serum 3. Samples: Sample Number 851/1 851/2 1035 

### Date Made 01/14/88 01/14/88 05/19/88 

### Dates Tested 05/11/88 and 05/18/88 05/11/88 and 05/18/88 08/03/88 

### 4. Dilution: Undiluted 5. Exposure: 30 seconds 6. Subculture Medium/Neutralizer: Letheen Broth 7. Incubation of Subcultures: 48 hours at 35°C 

## !

# ,().,?- /'

### 8. Plating Medium: Trypticase soy agar containing polysorbate 

### 80 and lecithin. 

### 9. Test organism: Test Organism staphylococcus aureus Klebsiella pneumoniae ATCC No. 

### 6538 4352 Phenol Res. Not Listed Not Listed 10. Results: See attached tables. 11. Conclusions: Results show satisfactory performance of the product against s. aureus and K. pneumoniae undiluted with a contact time of 30 seconds.

### Page

## pages~ is not included in this copy. through are not included In this copy.

The material not included contains the following type of information: Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control**pr~cedures.** 

### Identity of the source of product ingredients.

______ Sales or other**~ommercial/financial** 

### information.

_____ A draft product label. The product confidential statement of formula. Information about a pending registration action.

## ~FIFRA registration data. The document is a duplicate of page{s) The document is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your**~'equest.**

### EFFICACY EVALUATION AND TECHNICAL MANAGEMENT SECTION EFFICACY REVIEW - II Antimicrobial program Branch



### 777-68 EPA Reg. No. or File Symbol "-'-'---='_

_ 

### 04-27-90 Date Division Rece i ved 

# -'==-=-==

_ 414597-01-03 Data Accession No.(s)**~~~~~~_='_** _ 

### Product Manager No. PM 31 (Lee) Product Name Lysol Pre-Moistened Bathroom Touch-Ups Disinfectant Cleaning Wipes Company Name Lehn 

### & Fink Products Group, sterling Drug, Inc.

### 202.0 Recommendations 202.1 Efficacy supported by the Data:
a. The submitted data appear adequate to support efficacy of the product as a virucide against HIV-l (AIDS Virus) on hard non-porous surfaces in the presence of moderate amount of organic soil (5% blood serum) undiluted with a contact time of 10 minutes at approximately 23°C. b. The submitted data appear adequate to support efficacy of the product as a fungicide against Trichophyton , mentagrophytes on hard non-porous surfaces in the presence of moderate amount of organic soil (S% blood serum) undiluted with a contact time of 10 minutes.
c. The submitted data appear adequate to support efficacy of the product as a non-food contact surface sanitizer against Staphylococcus aureus and Klebsiella pneumoniae on hard non porous surfaces in the presence of moderate amount of organic soil (5% blood serum) undiluted with a contact time of 30 seconds. 202.2 Claims Not Related to Human Health: Tne submitted for AspergillUS niger are not summarized in this report since claims against this organism are not considered to be related to human health. 203.0 Labeling
a. Change "Kills mold and mildew" to read "Inhibits mold and mildew". b. Above "SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION
. . . II 

### a statement should be included KILLS HIV ON PRE-CLEANED ENVIRONMENTAL SURFACES/OBJECTS PREVIOUSLY SOILED WITH BLOOD/ BODY FLUIDS in health care settings or other settings in which there is an expected likelihood of soiling of inanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission of human immunodeficiency virus Type 1 (HIV-l) (associated with AIDS).

# &EPA Please read instructions and notice on reverse**b~'~re** completing arm. Form Approved OMS No. 2070-0060 Approval expires 6-30-90 mited StatesEnvironmental ProtectionAgency opp IdentifierNumber Office of Pesticide Programs(TS.767) 

# 124598 Washington,DC20460 

### Application for Pesticide: 

# 0 Registration GJAmendment Section t. Company/Product Number 12. Date 777-68 

### I 2/12/90 3. Product Manager John H. Lee (PM-3D 4

iXl' Proposed Crassntcanon r-1 Restric- X General I Ited 5. Name and Address of Applicant (Inc)udeZiPCode) Lehn 

### &Fink Products Group 225 Summit Avenue Montvale. New Jersey 07645


# n Check jf th;S Is a new address 6. Product Name LysolR Brand**Pre~Moistened** Bathroom



### . 

# ,,,. . Touch-Ups DisinfectiuS!: Cleaniu2 Wipes
t. SUbject 

# n fnesubmissio!'!.

... nrnal crlnted**l~b~1** 

## !XlOther (exn/aln below) Date of Letter Revision' of Product Label: 1. A virucidal claim against Human Immunodeficiency Virus Type 1 (HIV-1). 2. Product use instruction 'for the sanitization, of hard, non-ifood contact' 3. A claim of fungicidal efficacy against mold and mildew. 4. An expanded list of product use applications in vaDbus types of public and private establishments. surfeces , j,

Section III 

## DNo Ovos 1. Material This Product Will Be Packa ed In Child-Resistant Packaging Unit Packaging**W~-Soluble** Packaging nYes

### hN~ liVes nNo If "Yes," If ''Yes' Unit package wgt 

### INo. per container .,

## packa~e weight 

### INo. per container

. location of Net Contents Informatlon 4. Size(s) of Retail Container 

# "n label 

# -n Container

liOn label 

## H On material accompanying product 5. locatlon of label Directlons. 6. Manner in Which label Is Affixed To Product 

# = Uthograph 

# 0 Other (Specify) _ Paper glued Stenciled

Section IV t. Contact Point (Complete items directlybelowfor identiffcafion ofindividualrobe cdif ,m esfhi,,,,,j,-,,ti,,,l Name John J. Domanski Title Director of**Toxicolo~v** Telephone No. ('nc'udeArea Code) (201)573-7673 Certification I certify that the statements I have made on this form and all attachments thereto are true, accurate, and complete. I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable aw..

Pebruarv 14 

# /2/**j<'\,~'~.'** .. '**,~,..-** , , . 1990 of ToxicoloQ:v Director 5. Date Signed 

### -iJi 

## J,

" {)f 2. Signature 3. Title

# ~U'\1 ./0
John J. Domanski EPA Form 8570-1 (Rev. 9-88) previous editions are obsolete.

# 0G, pm '3 

# J fC,?>,**~This** is an accepted submission. One copy of the PPC diagnosis and one of the annotated bibliography are provided for your files. The PPC has already mailed out the submitter's copies of the two documents.

This is a**p:rt1~11y aee&?t.d/rej~e~cd**  SuQnission. A copy of**t~e :~C** **~iagnosis** and vi the annotated biOliography (if applicable) are provided fer ycur files. 1\ second eopy is provided fClr your ll!'#> in ccr-r-eapondinq with**'::l~** c3.'::.a :-..:bmitt.er.U.S. ENVIRONMENTAL PROTECTION AGENCY 

### Office of Pesticide Programs

LEHN & FINK PRODUCTS CORPORATION 225 SUMMIT AVE. MONTVALE, NJ 07645 Report of Analysis for Compliance with PR Notice 86-5 

### APR ., c: 

## 4 /.000

Thank you for your transmittal of 02/15/90. Our staff 

### has completed a preliminary analysis of the material. The results are provided as follows:
Your submittal was found to be substantially in 

### compliance with the standards for submission of data contained in PR Noticeo86-5, 

### with the exception{s) noted below. A copy of your bibliography is enclosed, 

### annotated with the Master Record ID's (MRIDs) assigned 

### to each docu- ment Submitted. Please use these numbers in all future references to these documents, and correct the noted exception(s} in future data submittals. If deficiencies were found which apply to your overall submission, they are described following this paragraph. If the defic- iencies apply to specific studies, they are listed below fOllowing the applicable identification number or MRID. Thank you for your cooperation. Any document which has been assigned a MRID has been accepted under PR Notice 86-5. If any comments related to a MRID appear on this report, they are provided for your information and reference when preparing future submissions. If you have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released. MRIDS 

### 41I.fS'J7(J)! deficient for the 

### I.flYSQ7a 2.- were all found to be following reason/s: The Good Laboratory Practice Statement shoUld appear on page 3 of the study. See page 17 of PR Notice 86-5.



# /33

# /
Lehn & 

# FinkProducts Group, Sterling DrugInc. 225 SummitAvenue, Montvale.NewJersey 07645/201 573-5700

., • February 14, 1990

Mr. John H. Lee (PM-31) Disinfectants Branch Registration Division (H7505C) 

### u.s. Environmental Protection Agency 401 M street, 

### S.W. 

### Washington, D.C. 20460 414S97-(/)(/)

Dear Mr. Lee: RE: LysoIR Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning wipes (EPA Reg. No. 777-68) Lehn 

### & Fink Products Group is pleased to inform you that the specified changes in the labels (packet and box containers) for the pesticide product 'cited above have been made in 

### accordance with the instructions outlined in your letter of**Sep~ember** 

### 8, 1989. It 

### is also our wish at this time to amend the registration of the sUbject product in regard to the development of a master label which will include two new container concepts for this product, viz. a pouch and a canister containing 20 and 25 pre-moistened towelettes, respectively. The amendment involves the following label modifications:



# · (1) Volume 1 - Administrative Materials ", : •. A. Application for Pesticide Amendment (OpI'.•••• Identifier No. 124598)

- Revision of •••• Product Label (EPA Form 8570-1; Rev. 9-88). In support of this petition, the following enclosed documents are being submitted for your consideration approval: 1. 2, 3 , 4. A virucidal claim against the Human Immunodeficiency Virus Type 1 (HIV-1) Product use instructions for the sanitization of hard, non-food contact surfaces. A claim of fungicidal efficacy against mold and mildew.

. A greatly expanded list of suggested**applica~ions** for which the product may be used in many di!fernt types of public and private establishments. • • 

# ·

# ..... · anti· :



# .. 

# . •••••• • •• • • •••••• • •



# ..
.

# ....

• 

# ..... • 

# ......

· 

# .

.. 

# ......

• • 

# .. 

# ..

I

# r: : " 

# ,.• ':

### .
, B. Six copies of a typewritten mock-up of the new master label and the packet label, including one copy of each, highlighted for your convenience, to indicate the changes referred to above. (2) Volume 2. Product Performance Data Requirements (158.160) A. IlVirucidal Efficacy of Pre-Moistened Travel Pack" (91-2, f , Virucides). (Three copies). Human Immunodeficiency Virus Type 1 (AIDS Virus) • (3) Volume 3. Product Performance Data Requirements (158.160) A. IISanitizer Test for Inanimate, Non-Food 

## 414S--e,7C2.- contact sur-reces in the Presence of Organic 80i1 11 (91-2, j, Sanitizers). (Three copies) Staphylococcus aureus; Klebsiella pneumoniae. Volume 4. Product Performance Data Requirements (158.160) A. 1I0isinfectant Wipe Test. Fungicidal Activity In the Presence of Organic soil (Modified AOAC Germicidal Spray Test)1I (91-2, e, Fungicides) (Three copies). Trichophyton mentagrophytes; AspergillUS niger. Your kind attention to this transmittal will be greatly appreciated. If you have any questions concerning the above, please contact me at 201-573-7673. Sincerely,

# CJf~(/Lj) John J. Domanski, Ph.D., D.A.B.T. Director of Toxicology JJD:RF Encl. 

## "

•



# /3-S-
,

### TO PRODUCT MANAGER<J.L 

# J;w /;J 

# jvI/

FAST - TRACK ACTION 

# I •

This action has been determined to be a fast-track action 

### by the 

### FEPS and must be entered in the 

### OLTS using one 

### of the following codes: 

### 160

- application for "me-too" registration 170

- application for registration

- old chemical - "Me too" 

### with additional use. 300

- Amendment

- label revision

- administrative (no data required)

. 

### 305

- Amendment

- label revision

- data required does not need HED/EFED review. 310

- Amendment- added "me-too" Use

- no HED/EFED review needed. 345

- Formula change

- no HED/EFED review required

## u.s. ENVIRONMENTAL PROTECTION AGENCY Office of Pesticide programs

LEHN 

### & FINK PRODUCTS CORPORATION 

### 225 SUMMIT AVE. MONTVALE, NJ 07645 Report of Analysis for Compliance with PR Notice 86-5 

### Thank you for your 

### transmittal of 02/15/90. Our has completed a preliminary analysis of the material. provided as follows: 

### staff The results are

The data accompanying your application have passed our initial screen for compliance with the standards for data submission con- tafned in PR Notice 86-5. When you resubmit your application package, we will check the data again. Thank you for your cooperation.

# .:
Lehn & 

## FinkProducts Group, Sterling DrugInc. 225 SummitAvenue.Montvale, NewJersey07645! 201573-5700

" • 

### February 14, 1990

Mr. John H. Lee (PM-31) Disinfectants Branch Registration Division (H7505C) 

### U.S. Environmental Protection Agency 401 M 

### street, S.W. 

### Washington, D.C. 20460 

### .'.597-CV@

Dear Mr. Lee: RE: LysolR Brand Pre-Moistened BC!t;hroom Touch-Ups**Disinf~cting** Cleaning Wipes (EPA' Reg. No. 777-68) Lehn 

### & Fink Products Group is pleased to inform you that the specified changes in the labels (packet and box containers) for the pesticide product cited above have been made in accordance with the instructions outlined in your letter of 

### september 8, 1989. It 

### is also our wish at this time to amend the registration of the sUbject product in regard to the development of a master label which will include two new container concepts for this product! viz. a pouch and a canister containing 20 and 25 pre-moistened towelettes, respectively. The amendment involves the following label modifications:



# · (1) Volume 1 - Administrative Materials ", : •. A. Application for Pesticide Amendment (OP?
..... Identifier No. 124598)

- Revision of •••• Product Label (EPA Form 8570-1; Rev. 9-88). In support of this petition, the following enclosed documents are being submitted for your consideration approval:



## , L 2, 3, 4 • A virucidal claim against the Human Immunodeficiency Virus Type 1 (HIV-1) Product use instructions for the sanitization of hard, non-food contact'surfaces. A claim of fungicidal efficacy against mold and mildew.

. A greatly expanded list of suggested applicabions for which the product may be used in many**di~fernt** types of public and private establishments. • 

# · . 

# .....

# . · ah<i· :



# .. . •••••• 

# . ., • • 

# ......

• •

• • 

# .....

• • ••••• • 

# ......

• •



# .. ......

• • 

# .. ..

# rJIJJ' Jr

B. Six copies of a typewritten mock-up of the new master label and the packet label, including one copy of each, highlighted for your convenience, to indicate the changes referred to above. (2) Volume 2. Product Performance Data Requirements (158.160) 

### A. o'vdruci.daj, Efficacy of Pre-Moistened Travel Pack" (91-2, f, Virucides). (Three copies). 

### Human Immunodeficiency Virus Type 1 (AIDS Virus) • 

### (3) Volume 3. Product Performance Data Requirements (158.160) 

### A. lISanitizer Test for Inanimate, Non-Food Contact Surfaces in the Presence of Organic 

### 80il 11 

### (9i-2, j I 

### Sanitizers). (Three copies) Staphylococcus aureus; Klebsiella pneumoniae. (4) Volume 4. Product Performance Data Requirements (158.160 ) 

### A. "Disinfectant Wipe Test. Fungicidal Activity In the Presence of organic Soil (Modified AOAC Germicidal Spray Test) 11 

### (91-2, e, Fungicides) (Three copies). Trichophyton mentagrophytes; Aspergillus niger. Your kind attention to this transmittal will be greatly appreciated. If you have any questions concerning the above, please contact me at 201-573-7673. Sincerely,

# ~J~/~) John J. Domanski, Ph.D., D.A.B.T. Director of Toxicology JJD:RF Encl.



### • 

# ..Lehn 

### & Fink Products Group

Title 

### rage Volume I

Volume 1. Administrative Haterials
Ae Application for Pesticide Arnendmerrt (OPP Identifier NOe 124598)

- Revision of Product Label 

### (EPA Form 8570-lj Rev. 

### 9-88).

B. Typewritten Hock-Up of New jtaat er- Label and Packet Label.

Product IdAntity; I,ysolR Brand Pr-e-Hot s t ened Bathroom Touch-Ups Disinfecting Cleaning Wipes 

### (EPA Reg. No. 

### 777-68)

Date February 14, 1990 

# Jt{O

- -04/1//%

Pa-oduot; Nerne s LYSOL BHl-l.tm**Pitr:.-HC";:S'l'.t:~Hm** DA.-l'HROQH 'I'OUCH-UP8 Company Name; LLHN & FINK PiWDUC'l'S Gi\Ol)P AppLf.cat.Lon No.: .1.2459:3 

### EPA Req. No.; 777-68 BPA Receipt Date: 02/13/90 Subject: 

### Front End Screen .fo'Z" an Amendment

'.\ . 

### Your application for reqistration has been received by 

### the Office of Pesticide Pr-oqz-arna and has pe.es ed a**P5e~j,.fnill,a,r;yscr~en.:**



### . for- completeness. 'Tt 

### will' 

### be 'pl'aced 

### in**lihe-:o-for,·r:e,~'f'ew··"..:ai~*,~;·):\':',~!~:>-·**

determine its acceptability. The application will be 

### p"rocesse"d" in chr-onoLoci.caI order of receipt. Alt.ucucb the 1988 E'IFRA amendments war-elate EPA to review epp.Ltca't.Lons for expedited z-eo

### ast ce.r.Lou or amendments :withiri 90 days) this t.urnar-ound time will not be mer, Lremedi.ec e Ly due to the oackLccr of applications received before December 24, 1988. 

### However, EPA is increasi.ng human 

### and automated 

### resources dnd makLno neces s er-y pz-o cedu.raL changes in order to eliminate the o a ckLcq and to meet; the 90-day response time as soon as possible. Produt;t you 

### have any queGtions, 

### you may Hanaqer 31, at P03j-557-3675. contact John Leer



### 1I?J27YC 

## 7#4?<tce' ,/-/?-j?d 

### Sil"t:.-"':relv,.

- 

# EL'l.5i/IJ2'frv<-J Team Lecider Front End Pz-oceas Lno staff**Reqigtl:at~on** Support Branch gecr.iata-ec Lon nfvLs Lon (H7504C)· -'., 

# o

03/12/90

P'roduc t; tle.',-,l2: i,':tSQL GW'.i';D pn:;-r-iOIS'i'ENEIi BA'Z'HHOOH TOUCH-UPS Company Naare r L:::i-Ii'J [. FInK**P~ODUCTS** GROUP Ap pLlcat Ion No.: 124598 

# L( SPll Reg. No.: 777-68 

### SPA Receipt Date: 02/15/90 

## / Subject: Front Sud Scr een for an Arnendmerrt

Your application for reg i s t r a t Lon has been received by the OffLee of Pest icide p r ccr eas and has passed a preliminary screen for completeness. It will be pLaced in line for. ,review 

### to det e r mLne its accept.abi 1 

### i t y , " The appl icat ion will be processed in**chron~logical** order of receipt. Although the 1988 FIPRA amendmenes-unandat e EPA to review eppLice t i ona .. for expedited r eq Lat r a t i.cn or amendments within 

### 90 days, th is turnaround time 

### wi Ll, not be me t; InunedLate Ly due to'· the**bac~~og** of**~P?lications** received**b~£ore Dece~ber**  

### 24, 1980. Hovever I EPA is increasing human and automated resources and lr.aking necessary procedural chanqec in order to eliminate the A- backlog lind to meet the 90-day response ti.lJE: as soon as possible. If you Lave any q ues t i onu you may ccnt act. John Len , Product**Ma~~~er** 31 at (703)-557-3675.

:Jllicerf:ly,



# t: JJif>)L/fvJ'1 't'e cm Leade r Front End Processing Staff R€Jt e t ro t Ion SUPj)ot't ar

### encr, F"€,g.lstr.::tion**Divi~ioll** (U7504C)

# TO P.M•.

# ---:=...1...

_ 

# DATE: , I


## FROM:

'-"--


## , THIS APPLICATION HAS COMPLETED TIlE FRONT END REVIEW.

,./ ICC) Certification I IrS) Service Person 

## Cl (R) Non-residential Use Only 

# ¥ (N) Not-1II;>plicable 

### /

Reference**~t.rnber** _ Inp.1t Date

_ 

### mom:; FOFl1 FOR APPLlCATlOOS FOR REXiIS'rnATtCN/AMmIl1ENTS
me S'-l/Req. No. 

## "TO- 8 

# r '" I 8 

## 1 Action Cede 

# J 6/ [10

## I Descriptor (Ameoo/ResUl:lllisions only) [5 

### I Intrastate call-in I I (Y) Yes 

### 1151 Olild-resistant Pack.agirq 

# II (N) No [201 Registration Type:.
. I / (1) Conditional

## ~2.) Unconditional. !25/proposed Classification: [30[ Final Class-ification: 

## L...J (R) Restricted I I (R) Restricted (G) General 

# c;z: IN) Not Classified 135 Date on Application: 1041 EPA Received Date: 

# lqiS**I~I~I** 

# L

# 110 

# 16'1 / 1)

# I~I f1) DAY YR f1)!lAY YR 

### laoI Method 

### of Support: 

### I I III Cite-All 

### I I (4) Not Applicable 

### / I (5) Not Subnitted Reviewers Requested: 

# L:7 (6)**~rSWni~ion** 

# o (7) Total Sul::mi.ssion

# ~) Selective Methcd Dt\1'E

_ 'IXJE CAI'E SEN!' Clt\TE RE."1'tJmED @ 

# '" PC CH 

### EP 

## IIiiiiI Status. 

# 1--+--+--1 

# I /' 

# b**/~** 

# "1/;/

1 ./ 

## , 

# J

/1151 FINAL Response I (/ ACI'ICH COOe 75-0M' R.ESPCfiSE OOE MTE: L.!(y) Yes 11201 Response

## IOI~CJI;,Jlglrl
.., OIlY YR / liN) No**~,** . -,EPA REGISTRATION N. 

# IDATE OF ISSUANCE US ENVIRONMENTAL PROTECTIONAGENCY 7Tl-6i3 n e- n An 1nnn OFFICE OF PESTICIDES PROGRAMS

REGISTRATION DIVISION (TS·767j TERM OF ISSUANCE vL.1 \IV IVVV WASHINGTON, DC20460 NOTICE OF PESTICIDE: 

## o REGlSTRATlON NAME OF PESTICIDE PRODUCT 

## o REREGlSTRATlON 1.,y::;01**~'L'"** .d !/t ,J -r;\,i1. ,'; t.\;!,'cC '10Ge(, "\';10 s (Under the Federal insecticide, Fungicide, G-isi .uec ti liS - , , " . ,':i I--I::>': and Rodenticide Ac!, a" amendedl ...**~,d"lli(J** HAME AND ADDRESS OF REGISTRANT fInclude ZIP code) 

### r 

# , Lehn ii,. I'ank s-roduc cs Grcui,J Division of aeer Linq D:r:u<j 225 Summit avenue ncnt.veLe**1.~1** 07645 

### L 

### ..J

NOTE: Changes in labeling formula differing in subslance from that accep!ed in connection with this regislration must be submitted to and accepted by the Registration Division prior to use of the label in commerce. In any correspondence on this productalw3Ys reier to the above U.S. EPA registration number, On the basis of information furnished by the registrant, the above named pesticide is hereby Registered/Reregiatered under the Federal Insecticide, Fungicide, a nd Rodenticide- Act. A copy of the labeling accepted in connection with this RegistrationjReregistralion is returned herewith. Registration is in nO way to be construed as an indorsement or approval of this product by this Agency, In order to protect health and the environment, Ihe Administrator, on his motion, may at any time suspend 'Or cancel the registration of a pest. icide in accordance with the Act. The acceptance of any name in connection with the registration of a product under this Act is not to be construed as giving the registrant a right to exclusive use of the name or to its use if it has been covered by others. This product is conditii cne Ll.y registered in accordance with FIF'Ili-\. section 3{c)(7) (A) provided that YOU: 1- Submitjcite all data required for reg.i5t r ati onjr-ereqist.ra t i 01. of your product under FIFRA sec. 3(c)(5) when chc Aqeucy requlres all registrants of similar products to submit such data. 2. Hake the labeliny cilangt:s listed ):)';,10'<1 08£Ul8 you 1"e10o..'>8 r:l ii, _,.1\.'(.] UC-;::' for Shipment: d. Add the phrase "EPA Registration No. 777-b8." b. Include the apfropriatB EPA I.::::;t. No. (box label & l--'dck<o::t label) • If these conditions ere not c ompLi ed with, the rGoyis i.rae.ton will**;,),.~** euoj ecc to cancella't.ion in accorda.uce wi til FIFRA**~uc.** 6{e) • Your: r e Lc.aae. [or shipment of the product coos

### m tutes acceptance of these condi t i ons , A st amped copy of til" label is enclosed for your**recul.·"~;** • 

# ¥,d-L/A.- deduct; naneqer (31) "AntimicrObial P'ro.j r am ucencn

1<ey is t.raei on Divis i on (H7505C)

LncLosu re 

# o I\TTACHMENT IS I\PPLICABLE

. SIGNATURE OF I\PPROVING OFFICII\L 

# IDI\TE

EPA Form 8570.-6 (R.v, 5·76) PRI;;VlOUS EOlTlON

....I\V BE USEO UNTIl. SUPPl.V lil EXHAUST EO. ;' 'C 

# 5**59790:I;CR-31:Le~:L-7:KENCO:09j05/89:10/17j89:CL:sw:vo:ek:dg**PACKET LABEL
FRONT LYSOLR BRAND PRE-MOISTENED BATHROOM TOUCH-UPS DISINFECTING CLEANING WIPES
ACTIVE INGREDIENT: Alkyl (50% CI4' 40% C12' 10% C 

### In) Dimethyl Benzyl Ammonlum Ch10rlaes INERT INGREDIENTS: 0.28%
99.72% Does not include weight of dry wipe. KEEP OUT OF REACH OF CHILDREN CAUTlON

BACK PRE-MO ISTENED LYSOLR BRAND BATHROOM TOUCH-UPS DISINFECTING CLEANING WIPES**"'''_CCE~TE[),** wjt!)'COI\-1ME1'-.'I'}'S, in'EP.t1 Letter Dated: 

# SEP 08 1989

See outer container for additional precautions and directions for use CONTAINER DISPOSAL: Discard empty envelope in trash.

EPA Reg. No. 777- EPA Est. No. Net Contents: one towe1ette Lehn 

### & Fink, Montvale, NJ 07645BOX LABEL FRONT LYSOLRBrand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes Travel Size The quick and easy way to clean and disinfect toilet seats and other bathroom surfaces anywhere you travel. CONTENTS

PUBLIC REST ROOMS

KEEP OUT OF REACH OF CHILDREN CAUTION See back panel for additional precautionary statements. ACTIVE INGREDIENT: Alkyl (50% G 14, 40% G l2, 10% G l6) . Dimethyl Benzyl Ammonlum Chlorlaes INERT INGREDIENTS: Does not include weight of dry wipe. EPA Reg. No. 777- EPA Est. No. 0.28'70
99.**72"1~**

BACK Quick Convenient Portable

LYSOLRBrand Pre-Moistened Bathroom Touch-Ups Disinfectant Cleaning Wipes Travel Size

The fast convenient way to clean and disinfect toilet seats and other bathroom surfaces anywhere you travel. Just wipe and flush away. Use Touch-Ups in hotels, motels, airports, rest stops, any public rest room where germs or bacteria may be a problem. Directions for use: It is a violation of federal law to use this product in a manner inconsistent with its labeling. Remove towelette from foil envelope and wipe surfaces clean. TO CLEAN AND DISINFECT TOILET SEAT: Use a fresh towelette to wipe toilet seat. Flush dirty wipe away. Allow surface to remain wet for 10 minutes. To disinfect heavily soiled**s~rfaces** repeat with a clean towelette. TO CLEAN AND DISINFECT OTHER BATHROOM SURFACES: Use a fresh toweletle accord;ng to directions above. Flush or toss dirty wipe away. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS 

### & DOMESTIC ANIMALS May cause eye irritation. Avoid cOntact with eyeS. Wash hands after use. STATEMENT OF PRACTICAL TREATMENT In case of eye contact, IMMEDIATELY flush eyes thoroughly with water, remove any contac t lens, and continue to flush eyes with plenty of water for at least J5 hl1nutes. Call a physician if irritation persists. STORAGE AND DISPOSAL

### SGtora~e: Store unopened package in a cool, dry place. 

# /U
.. 

# ,/."7 ontalner Disposal: Put empty box and envelopes in trash collection. , ' Manufactured by Lehn 

### & Fink Products Group, Division of Sterling Drug, Inc., Montvale, New Jersey 07645

# III Lehn & 

## FinkProducts Group, Sterling DrugInc. 225 SummitAvenue,Montvale, NewJersey07645/201573-5700


### August 9, 1989 PIlOGESS INFOllMATION IS NOTlNLLUuU)


### Mr. Valdis Goncarvos (PM-31) Antimicrobial programs Branch Registration Division (TS-767C) U. S. Environmental Protection Agency 401 M Street,· S.W. Washington,**D~C.** 

### 20460 

### Dear Mr. Goncarvos: Re: Lysol Sanitizing Wipes 

### EPA 

### Ref. No. 777-A! 

### As per your request, I am submitting a 

### +evised Confidential statement of Formula and a 

### revised manufacturing procedure for the subject product. I am also enclosing three (3) revised copies of labels for the outer box and for the 

### individual packette.

### Mr. Valdis Goncarvos Page 2 

### August 9, 1989 Recently, we conducted a study to show that we can extract most of the quat from our present towelettes. Four replicate towelettes were squeezed to remove the expressed liquid. Four new towelettes were extracted with hot methanol (a description of the procedure is attached). The expressed liquid and the methanol extracts were analyzed for quat. The results are presented below: 

### Sample No. % Quat in expressed liquid 

### % Quat after extraction of towelettes with 

### hot methanol 1 

### 0.306


### 9·449 2 ,0.305

0.448 3 

### 0.307

0.451 

### 4 0.312

0.453



### The expressed liquid contained approximately 59% of the 

### total quat added to the formulation. The hot methanol extract, which accounts for,the.expressed liquid and quat "bound" to the towelette, contained approximately 86% of the total quat added to the product. A more exhaustive extraction might recover additional quat but I do not believe additional studies are necessary. The information provided does show that a significant portion of the quat is held by the paper. Most importantly, all of our -studies have clearly demonstrated that we can deliver in the expressed liquid the level of quat specified on the product 

### label.

I hope the information provided above will**sati~fy** 

### the Agency. If you require additional information, p1ease**f.e~1** 

### free to give me a call (201-573-7673). 

# n e l Y

# fi{e/s~d Director

# Of~~::lOgy
JJD'ck Encs.Record Nunber Reference NUilber

_ Input Date _ CODING E'ORM ffiR APPLlCATlOOS FOR REGISTRATICN/lIMENtMENTS

/ / (4) Not Applicable / 

### I (7) Total sutmission / / (5) Not Sutmitted / / (8) Selective Methcx:1 

### IzslProposed Classification: 

### 1301 Final Classification: 

## LJ (R) Restricted / / (R) Restricted / / (G) General 

### II 

## eN) Not Classified 

## 1351 Date on Application: 

## 1041 EPA Received Date: 

## 101 

## tj //1 5 /1>' 

## l't 

# I 10 1'( 

# e rrl
M) DAY YR 00 DAY YR 

## lao I Methc:d of Support: / /(Cl Certification /' /(8) Service Person / / (R) Non-residential Use Only / I (N) Not-Applicable

RESPCNSE RESECNSE roDE IYI.TE 

# 1--1--1 140

## I Date Received by PM



# 1 0lceld-p

# [~ 

# Iii >lJ llI\Y YR Child-resistant Packagirq PM 

## I 8 

## I Action Code 

## /6/

OOE llI\TE . / / (2) Unconditional

/ / (6) CMner sutmission Descriptor (Amend/ResUl:::misions only) Intrastate Call-in / / (Y) Yes 

## 1151 I I (N) No

RD PM ;--7 (1) Cite-All 

### 110 

## I 

## lSi
1201 Registration Type: / / (1) Conditional File Symbol/Reg. No. 

## '777- 

# AI'

Reviewers Requested:


# l PL CM EF

75-llI\Y RESPOOSE OOE llI\TE: I I(Y) Yes

### O(N)NO~ 

# P{-(Il j) 

# Ij'11 15lJ

>lJ llI\Y YR

# PM31 REG. NO PRODIJCT 

## fJ(P1>1 d' 

## s

## /e-;.A../**/,I/,~** 

### 777- ---4:£

NAl-1E F.S.

uete or appttcett on vate recelvea Oy F: Ivate reterreo t o I;::'S Date or-ojecreo return

### Cj-IS-~**'i~2()-Y\** 

## S-6B/f 

## 6-/7- 

## 'if({ 

# o New Dl"'roro- 

# o «rreno- D New 

# o -r-otc- 

# o i<eSUO- 

## Do", Action voce ruays m 1:::5 Soutine type rent Chemical co t mission 

# /6/ 

# fOl Ovther



### . COMPANY

NAME

DSteri1tzer 

# o Pools Qspas DHospita1 

## 0 General

..Oisinf. Dfs tnf

. DSanitizer 

## 0**I~regna** OAir**D~fc'ng** F. C. $. ted Art. Sanitizer Use 

# o Algict de oPreserva- 

## 0 San iti zergl tmtc tce ttve N.F.C.S. OOther 

# o New Users**~EV:~i<~** Recctreo Iidentify oata: tnotcetec tvoes, ecc . n<."$ other cer-e tnent tntor
. Date irl Date aUI 

## IX CHEM fl-e."Uv CnC 

### -;- I ._ I 

# ,-;: 10-/7 

## :ox • I 

## IX E-::"**t2tzL,~** I 

# - An-<: L-. / 

### S-.b 

### I

htatus cet Is.-orcjecteo re curn C;.:RONOlOGICAl :-l!S'7lJRY OF EV£NTSI;IN cevst-otber ::ertir.ent tnsormetion CONTACTS

## o Disinfeccancs B'ranch 

### NOl'Jl«111DID II'lIln'

## JHGUIlII'.Nl'

## INI'OIlWA1XlNI!l 

## 77]

- II.L 4 ';;'0- 

### >'2 

# 3< Le.<e_l

'" 7 

## tka",-e& 

# <f£MU-Z£pjj 

# 44/0-0 

# cIi!wv y 

# JbJ:- Prockc;t;TECHNICAL SUPPORT SECTION EFFICACY REVIEW - I Disinfectant Branch
IN 05/06/88 OUT 07/21/88

# S;~',",",'ua..9..**~~ ~~**  Reviewed By Srinivas Gowda qDate 07/21/88 EPA Reg. No. or File Symbol 777-AI NONE 04/20/88 Data Division 

### Received -o

__**-c~~~~C_** _ Impregnated Towelette/Hospital Disinfectant Type product 

## --"'======-======'-=-'===-======-" None MRID No. (s) • 

# =='--

_ PM 31 (Lee) pr-oduc t Manager 

## -''-'''-'=-''---'-'==-

_ Lysol Pre-Moistened Bathroom Touch-Ups Disinfectant Cleaning Wipes Product Name 

# -'==-"--"-=---'-===="'--'-"====-===-'--="'-

_

company Name Lehn & Fink Products Group, Sterling Drug, Inc. Submission Purpose Resubmission to provide requested data* and revised proposed labels Single Use Disposable Impregnated Towelette Active Ingredient(s): % Alkyl (50% C14, 40% Cl2' 10% C16) dimethyl benzyl ammonium chlorides .......•.•.••......•..•.. 0.28 *The requested ATCC Nos. for the test organisms are as follows:

Salmonella choleraesuis Staphylococcus 

### aureus pseudomonas aeruginosa 10708 6538 15442 The submitted information completes and clarifies the data report. 

# /53TECHNICAL SUPPORT SECTION EFFICACY REVIEW - II Disinfectant Branch

EPA Reg. No. or File Symbol 777-AI7 

### 04/20/88 Da t a Divis i on Rece i ved ---''"-'--''-''-L='-

_ None MRID No ° t s ) 0 

# ==

_ PM 31 (Lee) Product Manager ---'-=--"-"---'-'='-'-

_



### . Lyso! Pre-Moistened Bathroom Touch-Ups Disinfectant Cleaning wipes Product Name 

# -""-'='--'-""--'-"===="-===="'-===---'=
Company Name Lehn 

### & Fink Products Group, Sterling Drug, Inc.
202.0 Recommendations 203.0 Labeling No.Adverse Comments

# Lehn & 

# FinkProducts Group, Sterling DrugInc. 225 SummitAvenue, Montvale, NewJersey07645/201573-5700

April 15, 1988

Mr. John Lee (PM-31)

## Ra:4iiI:I'H'·~kGn__,.....,.,.. Disinfectant Branch

.

## ftI2~ Registration Division (TS-767) U.S. Environmental Protection Agency 1921 

### Jefferson Davis Highway Crystal Mall, Building #2, Room 252 

### Arlington, VA 22202 RE: Lysol Brand Premoistened Sanitizing Wipes EPA File Symbol 777-Al EPA Letter Dated 5/1/87 Dear Mr. Lee-: 

### As requested in your review of the above package we submit the following:

Note: On the manufacturing procedure included in our original registration package, we explained 

### the difference between the label**decla:,~"=ion** 

### &n.i the available quaternary in the 

### liquia**~hase.** It 

### is.due to quaternary absorbed onto thp.**f~~ric.** 

# /1)..5

,10708 6838 15442

6275 

### John Lee Lysol Brand Premoistened Sanitizing Wipes April 15, 1988 

### Page 2
2. 

### Efficacy Data: a) The ATCC numbers for the organisms submitted are as follows: Salmonella choleraesuis Staphylococcus aureus Pseudomonas aeruginosa**Asp~rgillus** 

### niger b) The non-woven fabric is 

### a rayon pOlyester blend. This was used to conduct all efficacy, tests. 3. 

### Corrected "Certification with Respect to Citation of Data" is attached. 

### 4. Also included are five 

### (5) draft labels incorporating the changes requested. We have also changed the name of the product to LysOl Premoistened Bathroom Touch-Ups. We hope the above responses will answer all questions regarding the above submission. If you have any further questions on this package, please contact me directlY at (201) 573-5788. 

### Thank you. Sincerely,

Deirdre O'Connor Director Product Development DO'C:GMG Att.LYSOL 

### Pre-Moistened. Bathroom Touch-Ups 

### Disinfectin;r cleaning Wipes FR:Nr 

### 20 

### In:Ii vidually Wrapped 

### Pre-Moistened To>Ielettes (8 

### x 5 3/4)



### Travel Size The quick and 

### easy way to clean and 

### disinfect toilet seats and other 

### bathroom surfaces anywhere 

### you travel. 

### RlBLIC REST rocMS 

### Active Ingredient: Quick • 

### Convenient • Portable**~l** 

### (50!C14, 40% C

### , 2, 10% C

### , 6) 0.28% DllTethyl t>enZYl AmorlIom ChlOrIdeS 

### INERT INGREDIEN'IS 99.72% Does 

### not include weight of dJ:y 

### wipe. EPA Reg. 

### No 777- EPA 

### Est. No. 

### #### Keep out of reach 

### of children Cl\I1l'ICN: See 

### back panel for 

### additional precautionary statements•

Travel Size BlICK 

### Pre-Moistened Bathroom Touch-Ups 

### Disinfectant Cleaning Wipes The 

### fast convenient way to clean and 

### disinfect toilet seats and 

### other bathroom surfaces anywhere 

### you travel. Just wipe and 

### flush away. Use Touch-Ups 

### io 

### hotels, m:>tels, ai.r};x:>rts, 

### rest stops, 

### any public rest 

### room where genus 

### or bacteria may be 

### a problem. Di.rect:icns 

### for use: It 

### is a viOlation of federal law to 

### use this product in 

### a manner 

### inconsistent with its labelin;r. Remove 

### towelette fran foil envelope and 

### wipe surfaces clean. 'IO cr.EAN .AND I>ISINFECr 'IOIIEl' SEAT: Use a 

### fresh towelette to 

### wipe toilet seat. Flush dirty 

### wipe away. Allow surface to remain 

### wet for 10 minutes. To 

### disinfect heavily soiled. surfaces repeat 

### with a clean 

### towelette. TO CIEl\N AND 

### DIS:INl"ElC!r OIHER BMHRlCM 

## sum=: Use 

### a fresh 

### towelette accoruinq 

### to directions above. Flush 

### or toss dirty 

### wipe away.

Division of Sterling Drug, 

### Inc., Distributed by 

### Lehn & 

### Fink Products 

### Group, Montvale, NewJersey 07645 ST1Il»lENl'S HAZARDS TO HUMANS & ro1E'STIC ANIMALS 

### May cause eye irritation. Avoid contact with 

### eyes. If contact**w.:.~~ ~yes,**  =:!."..13h 

### with plenty of water. call physician if irritation persists. wash hands 

### aftar use. S'l1:lll\GE AND llISrosAIIstorage: store 

### unopened peckage 

### in a ceol, dry 

### p'lece, Disposal: Put empty box and 

### envelopes 

### in trash 

### collection.

### LYSOL R PRE-IDISTENED I3MlffiOCM mlCH-UPS DISINFECI'ING Cl.El\NING WIPES
ACI'IVE INGREDIENT: 

### Alkyl**(50~_C14'** 

### 40% C12, 10% C t 6) Diloothyl =1 

## -.on= Qllorldes 

### 0.28%
99.72% Does 

### not include 

### weight of dry 

### wipe.

PRE-IDISTENED I3MlffiOCM mlCH-UPS DISINFECI'ING Cl.El\NING WIPES
STATillENT OF PRACI'ICAL 

### n<EA:IMENT: May 

### cause eye 

### irritation. Avoid contact 

### with eyes. If contact 

### with eyes, flush 

### with plenty of 

### water. call physician



### .if irritation persists. Wash bards 

### after use. Dispose of 

### errpty envelope 

### in trash.
EPA Reg. No. 777- EPA 

### Est. No. 

### ####

# I G;rrIFIC;TICN WITrl RES?Ecr TO CITATICN OF' rYl.TA EPA File Syml:ol/Reg. No. -,-7-,-7-,-7_-

_ Da':e of application 

### 5/3/86 

## , LV50J R Brand Sanitizina Wiaes Name of prccocc

__**"""""---'''-',,"'-'~'-'-'-1.'''-,",,-''~"'''-** 

### _ Lehn 

### & Fink**Praduct~** 

### Group Division of Sterl iog Drug, Inc. Anpl icant' s Name and Address -'--"--'--"--'--:....;..:..;===.....:.....:.::!:

_ 

### 225 Summit Avenue 

### Montvale, NJ 07645 1. This application is suppo:rted by all data sutmitted or cited in the application. In addition, 

### if cite-all options are indicated, this application is suoportied by all data in the ).yency's files that concern the propez-cies or effects of**~,is** product or of any other product that is identical or Substantially similar, and that is one of the types of data that would be . required to be submitted 

### if this application sought the initial registration of a product of identical or sbnilar composition and intended uses under the data**requi~ents** in effect on the date of approval of this application. 2. I certify that, for each study cited in support of this application for registration that is an exclusive use study, I have obtained the written pemdasfon of the original data subnitter to cite that study•



### .' 3. .1 certify that, for each study cited in support of this application for registration that is not an exclusive use study: I have obtained the written permission of the original data .submitter 'to cite that study;

I have notified in writing the conpanies who have subnitted nata I have cited to succorf -this application and have offered to: (a) Pay ccrceosaeton for those data in accordance with section 3(c)(1)(D) and 3(c)(2)(D) of .the Federal Insecticide, Fungicide and .Rodenticide Act; and (b) Cctmence negotiations to deter.nine which data are subject to the compensation requirement of F'IFRA and the amount and terms of ccmpensation due, if any. The canpanies I have notified are: (Check one)

submitted the studies which I have
Signature 

### 5/8/86 Those companies who have cited (Selective method) I] All companies listed on the Pesticide Data Subnitters List for all actdvs ingredients contained in my product (Cite-all method or cite-all option under Selective Method). (Also sign the General Offer to Pav Statement below.)

Title Director Research Ser-v l cas

Director Research Services Title 

### 5/8/86 Date ...:..;"-'-'-'--

__

-,.-. "':"'-REV!sD 1-6-85**~ef~r~nce** 'fumoer

_

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### [':: !e.r ':.i

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### ; / (l)Yes / / (3)Not Appl1C3C**I~** (2)_ S_a.1tUd (R)RutrfotIU


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### Page Pages 

# 1&>/ is not included in this copy. through 

## 1t;z.:3 are not included in this copy. 

# ,

The material information: not included contains the following type of Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control prqcedures.

______ Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label.

______ The product confidential statement of formula. Information about a pending registration action. FIFRA registration data. The document is a duplicate of page(s)

______ The document 

### is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your request.

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# MAY

# a1 '1987

Lehn & Fink Products Division of Sterling Drug, Inc. 225 Summit Avenue Montvale, NJ 07645**Attention~** Deirdre O'Conner Director Research Services Gentlemen: Subject: Lysol Brand Premoistened Sanitizing Wipes EPA File Symbol 777-AI Your Application Dated May 8, 1986 A r-evdew of your application package has determined that it is incomplete. In order for us to continue processing this application,

-. ';-,'

- .submit-"the"-followimj,;i:nformatiori.

.**,,~'.~** ,,' ", ,<' 1. The product chemistry is incomplete.
a. Submit the complete chemical comPosition, chemical name, CAS Number, Material Safety Data Sheet, etc., for the ingredient:

b. not agree with your {CSF}., Are**yq~** ,usigg Please correct and 

### sUbmfE-new:-·CSF--andjor

-new manufacturing procedure. Note: should According to the manufacturing declare 0.52% active. procedure, your label
2. The efficacy data submitted are incomplete.
a. The ATCC Number for all three test organism must be sUbmitted. b. Identify the nature of the nonwoven fabric. Is it cloth, crepe, rayon, etc.?

OFFIOIAL FILE 

### oor-v -". '.- -'.' .' ,., , 92373: I:Lee:L-14;KENCO:4/16/87: 4/28/87: SONJA: VO:EK:SONJA R: 9238 I :Lee

# ,t- I 4:KENCO

# .**'/20/81c8~~N~** 

# ,VQ. EICBJP j

## , SYMBOL O"''''oHATOIt



### ................. .......................... .......................... .......................... ........................... ........................... ........................... ....................... ... 

# /t;
.. SURNAME 

## ,
................. .......................... .......................... .......................... ........................... ........................... ........................... ..................,

### ........ , 

### ............

## ,............... DATE; 

### ,,; 

### {

. , 

# -

. 

### . 

# . . .' . 

## - . 

### . 

# . ,2 What kind of cloth was used in conducting the efficacy data? You must be specific. 3 .. The form ·Certification With Respect to Citation of Data" is incomplete.. The Method of Support box was not checked , Please check the "Cite All" box or the ·Selective" box, initial it, redate it, and resubmit the form. 4. SUbmit five (S) draft labels incorporating the following revisions. Do not sUbmit final**labels~** a , Since inert inqre!dents do not include the dry wipes. there should be a. statement Placed below the ingredient statement "Does not include the weight of dry wipes

..- b , The net contents should include the number of saturated wipes and the net weight of the wipes

.. c. Under use directions for disinfectant, the directions for heavily soiled surfaces must be revised to indicate that the surface must first be cleaned with one towelette. and tnen disinfected with a second fresh towalette. a , Under "Directions for Use· change "Mold and Mildew Preventionlf to read ·Mold and Mildew Control· and also change ·To prevent" to read ·To control..•
e- Expand the directions for use for disinfecting toilet surfaces' to indicate exterior toilet boWl surfaces and toilet seats
.. £.. Delete the nUlllber 777-XX.. This is not your Registration >lumber. g.. The statement ·Active Ingredients· should be singular.. Delete the letter lOS.. " h , The correct format for the front panel precautionary statements is: KEEP OUT B.EACH OF CHILDREN CAtJ'rIOY See back panel for additional precautionary statements
.. L, Include the headingl Storage and Disposal to appear. directly above your Storage/Disposal. statements.3
5. For reference the following Accession Numbers have been assigned J Data Efficacy Toxicity*" Accession No. 262998 262997



## * six stuiies were SubIll!tted I however only two were reviewed (Skin Irritation and Dermal sensitization

- test materialJ wipe) the other four acute studies were not reviewed since a liquid was used as the test article. Note: No additional "toxicity stu:lies are being required at this time. 6. Due to deficiencies c.:j.ted above, do not subnit final labels at this time. This letter does not constitute registration and the product may be lawfully marketed untIl it is registered. Sincerely yours, ',.'.

John H. Lee Product Manager (31) Disinfectants Branch Registration Division (TS-767C)



# 1!p1

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# ITECHNICAL StiFPORT SECTION CllEll!STRY REVE'.

- i! 

### Disinfectants Branch


# 777 

# -.4I**JaC~** Division Received 

# s- J

### 3 8'6

z-cacces xanagee No. 

## ..31 ( 

# 'Lee;) '_
?==duc: Name 

# Lyso( I( 

# 13rtvtt..d SCLn,l/Zwt'ng 1d,;P€S Company Name 

# L e-ILh

. ...- 

## flroeUt

# e:ts 100.0 Comments:TECHNICAL SUPPORT SECTION TOXICITY REVIEW - I
Disinfectants Branch 

### OUT 10/28/86

### ~3/8~ U/; 'L>J ,.':'"d.'/;

## 1 Date 

### 10/27/86 5 E. Wilson, Jr. File Symbol 

### 777-AI EUP No. NONE ceived 

### 05/13/86 ,



### . I,(D), 

### H, F, N, R, 

## s 0(5) 26299'7

31 (Lee) Sanitizing Wipes Lehn & Fink 

### 5e New Application lation Impregnated tissue

### Cb-I~, by

### e'~;~7E

Chemical & Formu Company Name (s) 

### EPA Reg. 

### No. or EPA Petition 

### or Date Division 

### Re Type Product (s) : Data Accession N Product Mgr. No. Product Name(s)

Submission Purpo Reviewed

Active Ingredient(s) % 

### n-Alkyl (50% C14, 40% C12, 10% C16) dimethyl benzyl ammonium chlorides ••.•......•.......•.••• 0.28BACKGROUND
This product will used as a general use sanitizing wipe. RECOMMENDATIONS The data submitted are adequate to place the product in the following toxicity categories: Skin Irritation Dermal Sensitization 

### - 4

- Negative Four acute studies using a liquid as the test article were submitted but not reviewed. LABELING No changes required at this time. CRP STATUS Product does not require special packaging. DATA REVIEW Reports by Biosearch, Inc., sUbmitted to Lehn 

### & Fink Products Company, Montvale, NJ 07645, dated March 13, 1986. (Accession No. 262997). Skin Irritation Method

-

Results

- Six white rabbits received a single dermal application of a one inch square of material (wipe) on one intact site. After application the area was covered and occluded for 24 hours. Reactions were examined and recorded 1, 24, 48 and 72 hours after patch removal. Scores for erythema and edema were 0 at all sites all observations. Conclusion

- The product is not a skin irritant.

### Method

-

Results

- 

### -2- A one inch square of the towelette was placed on each of twelve guinea pigs and moiste"ed with 0.5 ml of physiological saline. After the six hour exposure the coverings were removed and the irritation evaluated. This operation was repeated, using fresh samples, three times weekly for 9 applications. After the 9th application the animals were allowed to rest for two**wee~s** 

### prior to applying the challenge application which remained in contact with the skin for 24 hours. Irritation was evaluated 24 and 48 hours**a~ter** 

### the challenge application. No irritation was reported after any application including the challenge phase. Conclusion

- The product under the conditions tested is not a dermal sensitizer.

### TECHNICAL SUPPORT SECTION EfFICACY REVIEW - I Disinfectant**B~anch** 02/11/87 OUT 02/09/87 I N_-"-"'-=-"-'

_

02/09/87 

## S",;,...;" iL\ 

## G-",.:<ll\ Sr:inivas Gowda Reviewed**BY_-"",-,,,,,,-,,,,,,---,=,,-,,-~,--** Date_-=,,-,=c..=.-,-
EPA 

### Reg. No. Ole 

### File Symbol 777-AI 

### EPA Petition 

### o r EUP NO. NONE 

### Data Division Received 05/13/87



# --- Type product;**Imp~egnated** 

### Towelette 

### /**Gene~al** 

### Disinfectant Date Accessi on No. (e ) .-'2,,6,,2,,9,,9,,8"-

_ PM 31 (Lee) 

### Pr-oduct**Manage~** 

# ---'=-=---'-''-=-'--------------**P~oduct** 

### Name Lysol Brand Pre-Moistened Sanitizing Wipes For-mula 86- 

### 256A Company Name Lehn & 

### Fink Products Group, sterling Drug Inc. S 

### ubrnL

### ss ion Pu:,cpose_-,N"e"w:....:A",p",p=l=.i"c"a"'t"i"'o"n'-

. _ 

### Type Formulation Single use Disposable Impregnated Towelette

Active Ingredient(s); % Uky1 (50% Cl4, 40% C12, 10% C16). 0.28 

### Dimethyl benzyl ammonium chlorides200.0 200.1

200.2

201.0 201.1

201.2 Introduction Use ( s ) The product is a chemically impregnated premoistened disposable wipe, wiped over the surface to be treated. 

### The produc t; 

### is intended for use as a "one-step" cleanerdisinfectant for moderately soiled surfaces, or as a "two-step" cleaner-disinfectant for heavily soiled 

### surfaces. It 

### is recommended for general c Lean I nq , disinfecting and deodorizing all hard non-porous surfaces. Background Information The submission received 05-09-86 is an application to register a new product. proposed product label and efficacy data were provided. Data Summary (Acce5sion No. 262998) Brief Description of Test The data report dated 05-09-87, from K. O'Donnell of the Lehn & Pink pz-oduct s Group, Sterling Drug rnc , , 225 Summit Avenue, Montvale, New Jersey was submitted to support efficacy of the subject product as bactericide/ mildews tat in the presence of 5% blood serum by a Modified A.O.A.C. Germicidal spray Products Test. Test procedure and results for microorganism survival after drying on a carrier was also submitted. Test Summaries
a. Bact e rLc Lda I Tests 1. Method: Simulated-use Test modified from the A.O.A.C. Germicidal spray Products Test. 2. Modifications; See attached "Procedure". Inoculum includes 5% blood serum. 3 • Samples: 

### All three samples were made on 12-20-85. Test DateS 

# )**i}~f** Batch NO. 

## s. aureus 

## s. choleraesuis P.aeruginosa 1 01-30-86 02-05-86 02-20-86 2 02-21-86 01-23-86 02-26-86 3 03-13-86 03-21-86 03-27-86 4. Expos uz-e Time: Slides were wiped with one t owe Le t t.e for 10 seconds and then liquid squeezed fz-om t oweLe t t;e to completely cover the slide. Both treated slide and wipe were allowed to stand for a 10 minute contact time.5. Subculture Medium/Neut:cali.zel·:After contact time of If) mi nu t.es both the treated 81 Ide ann 0.1 ml of e xpz'es s ed Lfqu l. F:::':"O!l\ the wipe weze subcultured in letheen br:oth; checked for absence 0E stasis after inoculation ano ce-incubation of negative t.uiJf:"::i\,.llt'1 301-60 or:ganisms/ml. Exp

### z-ea s e d liquid (0.1 ml) from each t.oweLe t t;e were double subcultured in letheen broth. 6. Incubation of Bubcu Lt.u

### z-es : 37 C fOr 48 hours. 7. Test ATCC Phenol Ha.cteria No. Res. Staphylococcus aUreus 1,70 Salmonella choleraesuis Not Listed 1:90 Pseudomonas aet"uginosa 1:90 8. Microo:t:anis!1l gucvLveL After Drying on a Hard Surface: Test organism w/ 5% Blood Serum**Staphylococcu~** aureus Salmonella choleraesuis Pseudomonas aeruginosa 9. Test Results: Ave.No.Survivors**Befor~rying/Slide** 1.2 

### x 10 8 1.2 

### x 108 1.1 x 107 Ave.No.Survivors After Drying/Slide 

### 9.6 x 10

### 6 1.3 x 107 1.7 

### x 10 6

Test Organisms
S. au!:eus

S. choleraesuis

P. aeruginosa Batch No. 

### ceezte i-e No. Positives/ No. Tested Total Caz-z-Lez-s Towelettes Slides Primary. Secondar:t. 1 60 1/60 0/60 0/60 2 60 1/60 0/60 0/60 3 60 

### 0/60 0/60 0/60 1 60 1/60 0/60 0/60 2 60 0/60 0/60 1/60 3 60 0/60 0/60 0/60 1 60 1/60 0/60 0/60 2 60 1/60 0/60 0/60 3 60 1/60 0/60 0/60 10. Conclusions: Results show satisfactory performance of the product as a general disinf'ectant against Staphylococcus aureus, Salmonella choleraesuis, and Pseudomonas aeruginosa in the pz-esence of 5% blood sex-cum,b. Fungistat test (Mlhlewstat) Fungistat activity confirmed by the test method EOL evaluation of mildewstats on hard s uz-faces against**Asp~Lgillus** nigeL ATCC NO. 6275. See attached
" Pzocedur-e II 1. Conclusion: Resul ts show sat Laf act or-y pez-foz-mance of. pLoduct vs A. nigeL with 5% blood seLum.

### Lt.-.lln 

## & 

# fink**F,lr{)~_~tl(·t~ (~':'()UIP,** **:-I~,:lt!:~, !,~'11,**  

## t«.**~~.::: 5d::ll~lit**  ';"0::-'"1,1'**.',~;·n~v.j,-** ',.- -. j,_,.y\**,-"'~'c** 1': ,I :;(,j 5"' :-:;:



### Lysol Brand Sanitizing Wipes Formula H6-256A Germicidal Activity

- Hard Surface Disinfection
Procedure: EPA Efficacy Data Requirements for**~ingle-Use** 

### Impregnated Towelettes for Hard Surface Disinfection and acceptable modifications as per our discussion with Mr. Dennis Guse 12/9/85. Modification of the A.O.A ..C. Germicidal Spray Test 14 ed. 1984 pg. 71.
1. Each wipe is tested by wiping a 1" sq. inoculated glass slide. Glass slides'are prepared and inoculated with the test organism and 5% blood serum as per A.O.A.C. 4.031 

### & 4.032. 2. Each slide is wiped with one towelette for 10 seconds. After wiping, liquid is squeezed from the towelette to**com~letely** 

### cover the slide. Both treated slide and wipe are allowed to stand for a 10 minute contact time. 3. After contact, both the treated slide and 0.1**~l.** 

### cf**express€~** 

### liquid from the wipe are subcultured in letheen**brc~h.** 

### Expressed liquid is double subcultured in letheen broth. 4. All 

### subculture tubes are incubated at 370c 

### for 48 hours.

( '1 I i 1 j ,

## -f**::'?:t~_ :~**  

### H ,; 

## -.u.i 1 I;', i i ldU( 

## "Ceoup, i;,· "",'

1986



### Procedure: Lysol Brand Sanitizing Wipes Formula H6-256A Fungistatic Activity in the Presence of Organic 

### Soil
Hard Surface Mildew Fungistatic Test Method, as described in the Pesticide Assessment 

### Guidelines, Subdivision G. Nov. 1982, pg. -145-148, and the Federal Register June 25, 1975, Vol. 40 #123 pg. 26851 with modifications.

Modifications: 1. A. niger suspension contained 5% vjv blood serum
Each tile 

### is treated by wiping with the wet towelette for 10 s ccoi.ce . Liquid from the towelette is expressed to completely cover**t~- _~C~** **~~d** let stand for 3 minute contact. After 3 minutes the**ti~·** drained and dried in a 37°C incubator for 40 minutes. Both untreated and treated tiles are inoculated with 0.01 mI c i , .. 

### niger suspension and dried at 37°C.

j i 

# ! 7 lTECHNICAL SUPPORT SECTION F.;l:"'fICACY REVIEW

- II 

### Disinfectants BLanch

777-AI 

### EPA Reg. No. or File Symbol**~~~~** 

### __ Date Division Received**~O=5_-~1~3~-~8~6"_** 

### __ Data Access ion No(s )__-'2,,6'-'2,,9'-9'-8"-
... 0-. , 

### Produet Manager No. PM 31 Lee) Product Name Lysol Brand Pre-Moistened Sanitizing Wipes. Formula H6 - 256A Company Name Lehn & 

### Fink Products Group, Sterling Drug Inc.

### 202.0

202.2 Recommendations sirt Icacy Suppor-ted by the Data 

## rI""'""**~.** The submitted dataAadequate to support efficacy of the product as a hospital and/or general disinfectant against Salmonella**chole~aesuis,** Staphylococcus auzeus , and Pseudomonas aeruginosa on hard, non-cpoz-ou s s uz-face s in the presence of moderate amount of organic soil (5% blood s e r-um) with a cont ac t; time of 10 minutes. b. The submitted data also appear- adequate to SUppOL't efficacy of the product as a fungistat (mildewstat) 

### against Aspergillus nige:L in the pz-eaence of moder-at 

### e organic soil (5% blood serum) with a contact time of 3 minutes. Additional Data Required to support Efficacy


### a.**AT~C** No. foe all t hzee test organisms must**t:>'~** SU·1):'li. tced , POL the Efficacy Data Requ i r'ement s z-efe

### z- to DrS!TSS-3 e ncLo s ur-e , item b. 

### 203.0 Labeling
a e . Under' US8 Dfrec t; lons for disinfectant the d Lc-ect Ions fOL heavily soiled sULfaces must be revised to indicate that the surface must first be cleaned with one towalette,and then disinfected with a second fLesh t owe Let t.e , b. Under- n Ddrec t Lona fOL use" change II Mold And Mi Ldew pr-event.Lon II to read 'l Mold and Mildew Control II and also change " To prevent; " to zead " To cont z-ol "
c. CovrpLe t e rti eec t Ions for use must :)e lnojuded t-o c Lean and disinfect toilet surfaces.



# ·/0UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. ?0460



### EFFICACY DATA REQUlREMEm'S 

### Reporting of Data

(1) 

### Systematic and 

### complete descriptions of the tests employed and the results obtained are essential for proper review and 

### evaluation of product performance by 

### the Agency. All test reports must include identification of the 

### testing laboratory or organization, when and where the tests were conducted, and 

### the name of the person(s) responsible for the conduct of the tests, Reconmended Methods. When the Reconmended Methods (such as standard ADM:. tests) are employed to develop efficacy data, certain minimal information must be provided in 

### the test report. The report mast; include, but is not limited to, the following: (a) (b) (c) (d) (e) 

### (f) (g)

(b) (i) 

### Test employed, and any modifications thereto; Test microorganisms employed, including identification of the specific strain, (ATCC 

### or other); 

### Concentration 

### ordilution of product tested and 

### how prepared; Number of samples, batches, and replicates tested; 

### Preparation data of each product batch (individually formulated preparation of the product; Phenol resistance of test microorganisms (actual test results); Identification of all material or procedural options employed, where 

### such choice is uermitted or recommended in the test method selected (for 

### exampIe, growth 

### media, drying time for inoculated carriers, neutralizer and/or subculture media, secondary subculturing) ; 

### Complete report of results obtained for each individual replication; Any control data essential to establish the validity of the test.

(3) 

### (2) 

### Modification of Recorranended Methods. Where Recomnended 

### Methods are s1gn1ficantly lOOdified to support specific claims aD.dlor we patterns for a 

### product, the protocol employed for modifying the test must 

## be provided in specific detail with the test report. The applicant may submit the proposed rodification for review and evaluation prior to initiation of the test. Other Methods. When Recomnended**~fethods,** 

### or modification thereto, are not employed to develop efficacy data (such as 

### actual in-use or many 

### kinds of simulated-use testing), complete testing protocols must be submitted with the test reports. All materials and procedures employed in 

### testing must be described in a manner consistent with original research reports published in technical or scientific journals. Where references to published reports or papers are made, copies or reprints of such references should be provided with the test reports. Proposed testing protocols for in-use or simulated-use studies of this kind may be submitted for review and 

### evaluation by the Agency prior to initiation of the tests. DIS/TSS - 3 29 

### Jan. 79 

### (Page 1 

### of 1)'MB No 2000 0483 Approv"/IIXp;r.$ 9 30 87 F 'A oem 

# t' • 

# &EPA ....... iACIRoAMII:NTltViiASTic¥loA.AGiN y , PS_ rud ilWtlUdiona O

.... ICII: 0

.. "II:STICIDIl "ROGRAM

# ',....7.71**APPlICATION~ORj,TE°sTrcCiDE:SD** .

## ~~~~::~~ON on

_ befO'" comA pi

....... '). SECTION I " I. COMPANY/PRODUCT NO.

### 12.0;;~/86 

## 111. "ROOUCT MANAGItIt ••**PltOPI'l,"'~O** c:..':A."."II<;ATIO'



### 777- 

# AI John Lee (PM-31) , []Gnlll"AL.

_ ""STRicTli:D
•• NAMII: AND AOORItSS 01" APPLICANT 

# "'. > 1,;0de}
lehn & Fink Products Division 

### of Sterl ing Drug, Inc. 

### 225 Summit Avenue Montvale, 

### NJ 

### 07645



### . OCNItCK I

.. THIS IS A NItW ADORItSS S. "RODUCT NAMIt lysol R , Brand Sanitizing Wipes SECTION II I. SUDJIl:CT 01" AMItNOMItNT DRIlSUBMISSION IN RIl:SPONSIt TO AGItNCY LItTTItR OATItD O

.. INAL "RINTIlO LABIl:L IN RESPONSIl TO AGENCY LItTTItR**DATir~'** OOTHIl:R**(.~pWn** hlow) 

### . , , ",

,

" 

## -.

. ..... " 

## ...•, 

# .

. 

# • ,-;,-," ,.

, SECTION III I. WILL THIS PRODUCT 811: PACKAGIl:O IN' 

## 2. TYPE OF CONTAINER' CHILD'RII:SISTANT "ACKAGING DyllS 

### I2lNO . DMIlTAL

,., 

## .'.' rn "LASTIC

- 

### - liPoo 

# . UNIT

..ACKAGING**~tll:S** 

# . . OGLASiIi II YES; unit pkll.wt: , No. per lXIntlin-et 

### 0"",:,_1'1 ,


### - - -"
, DYIlII: [8] NO 

### .. ' " • WATIlR 'SOLUDLII:

..ACKAGING OOTHkR (Spee/fy) If YES, pkll. wt. No. pit c:onulntlr

, 

## 11. LOCATION 0

.. NIl:T CDNTItNTS, 

# I.' slzlllS} 0

.. RItTAIL.CONTAINER 

## .. ;:: fiLABEL DCDNTAINItR 

### 25 .w

### l pes**7t~.1** x 10 1 ,: .. ." 5. LOCATION 0" LADEL DIRECTiONS , , s. MANNItR,IN WHICH LABEL IS AFFIXED TO PRODUCT ,"

Cil0N LABIlL 

# o LITHOGRA",N 'OOTNIl:R**(~pUlfy)** [):PAPER GLUIl:O DON**MATIlRIA~** ACCOM

..ANYING "RODUCT OIlTENCILIlO' 

## - .. 

### . 

## , <.

" SECTION IV ' '. " , 

### .. 1. CONTACT "OINT (Comput. lie".. dIrectly lIelow (ol" Id.ntltteGtlon oflndlllldll4l to bl eonlfU:l.d, e. DATil: A

.... LICATION RECItIVIlO Ifneeeu<D')l, 10pronu**Ih~** fIl'plleotwn).
" (Stomped) c**~i** " .:. 

### .. « ".' , NAM

.. 

### .. 

## --**",~ .,,~**  , Dei rdre OIConnor ;;," , , ' , , . ",-, , ;.,



### - TITL" -,

### 1z15f~~:~;8~(~elud. , •. >."
, -

# ...**~' ~,**  Oi rector Research Services 

## .. .,j 

# ,q**;;<~lf~~** 

# ,

# .

. ' a.**SI~~A~~~R)** L## tf~ 

## 111. TITLIl OJ r , 

### Reseer'ch' ; 

### '"' Services

•• TY"1l0 NAMIl '. )i ", ,1' 

### ., , 

### '., 

# .**I"~** OA,Iial;"86° c 

### "

## "" ,i• " 

### , 

## .. De i r-dr-e OIConnor


# ..**'·'~""I** .. :> 

# , EPA Form 8510.1 Insv. 6-811

.. "EVIOUS Il:DITION**I~** OIH.Ol.,Il:TE,

### Mr. John Lee (PM-31) -2- 

### May 8, 1986

8. 158.135 Confirmatory Microbiological Efficacy (2 copies)
9. Five (5) copies of the Prototype Label
As usual, if any questions arise on this application, please call me directly at 201-573-5788 so we can quickly resolve them. Thank you, Sincerely,

Deirdre O'Connor Director Research Services DO'C/ds attachments

# , , CERTIF'ICATlOO WIlli RESPECI' TO CITATlOO OF IYI,TA 

### 5/3/86 Date of encttcacton**_~":':":::'---** 

### __ EPA File Symtol/Reg. No. "7..:7..:7_-

_ 

### LysolR Brand Sanitizing Wipes Name of Product

__**'L"'-'---".!~!'\!"'-"-,,'!!.'.-'-'-£!"~-"-'-"''''-** _ 

### Lehn & 

### Fink P.oducts Group**Di~islon** 

### of Sterling Drug, Inc. Applicant' 5 Name and Address

__-''---C--'-C--''''---C-:..::.:..::.=--'':..:::.::rC-

_ 225 Summit Avenue nontvele , NJ 07645 L This application is supported by all .date sutmitted or cited in the application. In addition, 

### if cite-all options are indicated. this application is supported by**a~l** data in the Agency's files that concern the properties or effects of this product or of any other product that is identical or substantially similar, and that is one of the types of data that would be

. required to be submitted 

### if this application sought**t~e** initial registration of a product of identical or sbnilar composition and intended uses under the data requirenents 1n effect on the date of approval of this application. 2. I certify that, for each study cited in support of this application for registration that is an exclusive use study, I have obtained the written permission of the original data submitter to cite that study. 3. I certify that, for each study cited in support of this application for registration that is not an exclusive use study: I have obtained the written permission of the original data submitter to cite that atudyr 

### 2E. I have notified in writing the companies who have sut:rnitted date I have cited to succort; this application and have offered to: (a) Pay canpensation for those data in accordance with section 3(c)(l)(D) and 3(c)(2)(D) of the Federal Insecticide, Fungicide and.Rodenticide**Act~** and (b) Commence negotiations to determine which data are subject to the compensation requirement of FIFRA and the'amount and tenms of compensation due, if any. The ccmpanies I have notified are: (Check one) 

### [1 All companies listed on the Pesticide Data Submitters List for all active ingredients contained in my product (Cite-all method or cite-all option under selective Method). (Also sign the General Offer to Pay Statement below.) 

## r] Those canpanies who have subnitted the studies which I have cited (Selective method) Signature 

### 5/8/86 Date

_ Title Director Research Services

Di.ector Research Services Title 

### 5/8/36 Date 

## --..:=::..=:"---

__ General Offer to pay: I hereby offer and agree to pay compensation to other persons, with regard to the approval of this application, to the extent required by FIFRA sec. 3(c)(I)(D) and 3(c)(2)(D).

### ))~cf}'~

EPA Form (April 1985)**~--** 

## --_. ...

# _---- -.-.

ATIAffi'lli'NT A fORMULATOR IS EXD1PTICN STATEME1\!T E:PA File Symbol or- Product Registration Number: _-.:7'-'7'-'7_-

_ 

### Applicant's Name and Address: Lehn & Fink Products, Division of**S~.!29_** .._

Drug. fnc" 225 Summit Avenue. Montvale,**N,~J~O~7~6~4~5** ___ As an authorized representative of the applicant for reqratr-aticn of 'the 

### product identified above, 

### r hereby certify that: (1) Our product; is an end-use prcduct., tnd it contains the acti.ve i.rqr-edi.ent

### ts ) Alkyl (50% C14. 40% C]2' 10% CJ6) dimethyl benzyl ammonium chlorides


### (2) eaCh active ingredient listed in paragraph 

### {ll is present solely, = -he result of the incorporation into the product (during formul.atton or pacxaq i cq ' of another product whLch contains that active ingredient, '
.... his:h is reqister-ed under FIFRA Section 3 r and which is purchased by us fran another prccucer . 

# . {3} Indicate 

### by circling the appropriate ,text which paragraph applies: (A) An. accurate ConfIdent.Lal Statenent of Formul.a for the abcve adenti.fIed product; is attached to this s t.atenerrt, That fonnula s t.ateirent; 

### tncacet-s.. by canpany name, registration 

## ourrcer-, and product**nariie~-me** source (If the cccive ingredient(s) listed in paragraph**(1).~** 

### OR (Bl The Confidential 

### steeerene of Formula dated 

### cu file with the EPA is 

### ccrnp.lete s. current and 

### accurate and contains the i nforrmci.on requested on the cur-r-ent; CSF form No.**8570~4.** The registered sour-cets ) of rne active Inqredientrs ) listed i.n paragraph (1) is/are listed be.Low. Active Ingredient Alkyl (50% C14, 40% Cll, 10% C16) dimethyl benzyl emmonrum chlorides**~-----** Applicant's authorized representative: 

### (signatllie

Dated: 5/8/86 Deirdre O'Connor. Director Research Serv!ccs (cypedJDATA**RFQlJIRF.M~m'** LISTING FOR**TH~** avNSR SUEMISsIOO MF:JlIOD OF SIII"'lRT


### 1. LySOI' tirana 

### 2. SPA Rill.NO/FILS SYMBOL 

### 3 •
. 

### 4. PJ¥JIllIIT**NAM~:** Sanitizing Wipes 

### 777- FORMULATOR I S EXEMPTlOO SeLECTED P,'.GE I of 

# " 5. 

## - 

# --**Y~S** x l-+} APPLICANT'S NAME AND ADDRESS 

### 6. APPLICATlOO FOR lehn &Fink Products REGISTRATIOO DATED 

### 7.**NAM~** OF ACTIVE**INGR~DIENT(S):** 

### Division of Sterling Drug 5 / 8/ 86 Alkyl 

### (50% C 1qJ 40% 

## e12) 10% C16) dimethyl benzyl 225 summit Avenue Mo. Day Yr. 

### f1ontvale. NJ 

### olMS ammonium chlorides



# - - 10. 8. DATA REXlUIREMENTS 9.**SOURC~** OF DATA SATISFYING**REXlUIRF.M~m'** MRID**NUMB~R,** 8a. 8b. 9a. 9b. 9c. 

## se. ge. 

## se.**~PA ACC~SSI**  

### Regulation 

### Subnitted Date 

### Sutmitted Permission 

### Public Other NUMBER OR**OTH~~R** 

### Part 158/ 

### Name of Test by subnitted by 

### another Letter Litera- (Explain) SPA IDEm'IFYING GuideLi ne Applicant 

### person/firm Enclosed ture NUMBER Numher (name) 

# . S158.20 PRODUCT CHEMISTRY , , 

### 61-1 Identitv of inaredients x 

### 5/8/86 Confidentia Statement c F Formul 

### 61-2 statement of composition x 

### 5/8/86 Confldentia Statement"c F Formul 

### Discussion of fonmation of 

### 5/8/86 Henufecturl I g Process 

### 61-3 tnqredients 

### x 62-1 Preliminary analysis 

### 62-2 Certification of limits x 

### 5/8/86 Confldentia Statement f Formul ,.- 

### Analytical methods 

### for x 

### 5/8/86 Henuf'ecturlr 9 /1onograph 

### 62-3 enforcement 1 imits 

### 63-2 Color 

### x 

### 5/8/86 t1anufacturi 9 Monograph



### - 

## - physical state 

### x· 

### 5/8/36 Hanufacturi 9 tionograph 

### 63-3 x 

### 5/8/86 l1anufacturi 9 t\onograph 

### 63-4 Odor 

# :::::- nla 

### 63-5**"~eltino** point I'" 

### 03-6 Boiling**~int** 

### nla rxmsity,ulk density, or 

### nla 

### . 63-7 speci 

### fic 

### orevtty ---'DATA RI'X)!JIRE1-mNT LISTING !'DR TIm rnNER SUnMISSIOO flE:l1IOD Of SLJPl'lm'
I. TySOI' "er-enu 2. EPA REG.NO/FILE SYMOOL 3. 

## 14 • 4 Sanitizing Wipes 

### 777- 

# , Pronucr NI'ME: !'DRMULAWR'S EXEMPTICtI SZLECfED : ?N;f' of 5. 0 

# -- -- YES x NO 

# I APPLICANT'S NAME AND ADDRESS 6. APPLICATIOO !'DR

Lehn & Flnk Products REGISTAA:rrOO DATE[j 

### 7. NI'ME OF AcrIVE INGREDIENT(S) : Division of Sterling Drug 

### 5/ 8 /86 Alkyl (50% 

### C14 _ 40% 

### C12_ 10% 

### C16) dimethyl benzyl 225 .Summit Avenue Mo. Day Yr. 

### Montvale, NJ 07645 ammonium chlorides



# . I , 

### 10. 8. DATA REQUIREMEN'IS 9.
. SOURCE OF DATA SATISFYING REQUIREMEN'f MRID NUMBER, 8a. 8b. 9a. 9b. 9c. 9d. 

### ge. 9L EPA ACCESSIOO 

### Regulation



### . Sutmitted Date Suhnitted 

### Pennission 

### Public Other NUMBER OR CYI1HCR Part 158/ Name of Test , by 

### Subnltted by 

### another Letter 

### Litera- 

### (Explain) EPA IDENTIFYH.x3 

### Guideline Applicant 

### person/firm**En~losed** ture NUMBER Number (name)

, , 5158.20 PRODUcr CHEMISTRY (Continued I Eni Use Forn 63-8 Solubilitv n/a ulation 63-9 

### vaoor oressure n/a End Use For-nulation 63-10 

### Dissociation constant n/a End Use Forn ulation 

### OCtanol/water partition ! . u l etl on 63-11 

### coefficient n/a I End Use For • ! , 63-12 nil x 5/8/86 Confidential Statement 0 Formul
63-13 St.ab

### i l i 

### tv x 5/8/86 63-14 

### oxidtzirct/reducino reaction n/a , 63-15 Elemnab

### i Li tv x 5/8/86 Confident al Statem nt of ormula 63-16 Exo.lodabi I ltv n/a 63 17 

### ,,":'"stoI:"ane stabil it" x 5/8/86 1- h.",.'

<, n/a 63-JO 

### ·'·'.,,1Viseesi 

### tv



### - 

## - - fi3-19 

### Miscibil 

### i tv n/aDATA RrWIREMENl' LISTING !'DR 1118 ruNER SUBMISSION**~1E'11I0D** Of sUPfI);rr


### 1- Lyse I BrandSanitizing Wipes 

### 2. foPA REG.NO/fILE SYMBOL 

### 3. !4. PRODUCT N!'Jo1E: 

## 777- FORMUUIDR'S**E.:XEMPTI~' S"~'**  ...ECTED 

# I**r~2** _3 of 

### _4_ 

### 5. YES x NO



# ---- APPLICANT'S Nl\MF. AND ADDRESS 

### 6. APPLICKrION FOR 

### Lehn & 

### Fink Products REGISTRATION DA:rED 

### 7. N!'Jo1E Of ACTIVE INGRmIENT( S) : Division of-Sterling Drug 5 

### /8 /86 AIkyl 

### (50% c14' 40% e12' 10% C16) dimethyl benzyl 225 Summl 

### t Avenue Mo. Day Yr. ammonium chlorides 

### MOntvale, NJ 0)645



# -**~kJ**



### . 10 . 

### 8. DATA REXlUIREMENTS 9. SOURCE OF DATA SATISFYING REXlUlREMENT MRID NUMBER. 

### Ba. 

## ae, 9a. 9b. ge • . 9d. 

### ge. 9f. EPA ACCESS!(X'J 

### Regulation 

### Sutmitted 

### Date Sulmit 

### ted Permisai.on 

### Public Other NUMBER OR OIllEH 

### Part 15B/ Name of Test hy Sutmitted by 

### another Letter 

### Litera- 

### (Explain) EPA IDENTIFYIf\K.; 'Guideline 

### Applicant person/finn**En~losed** 

### ture NUMBER Number (name) 

### S15B.20 PRODUCT CHEMISTRY (continued 

### 63-20 Corrosion characteristics nla I 

### 63-21 Dielectric breakdown voltane n/e



# -- 11 lquld 

# I S15B.135 TOXIOJUlGY wipe 

### 81-1 Acute oral LD-SO, rat x 

### 5/8/86 x



### - 

### 81-2 Acute dennal LD-50 x 

### 5/8/86 x



### - 

### 81-3 Acute inhalation LC-50, rat



## - - - 

### Pr-imary 

### eye irritation, 

### 5/8/86 Bl-4 rabbit x x



### - I

### 81-5 PrImarv dearrnel 

### irritation x 

### 5/8/86 x x 

### Bl-6 Dermal sensitization x 

### 5/8/86 x**~"** .. 

# ek" ,-,- ,'"-'
- 

# .r'**.~~~_** ..

# ~" ..._'=-----.-..._-

### • Cleans 

### • Disinfects 

### • Dao:lorizes The quick, 

### easy way 

### to clean ani kill household 

### gems!

I<EE:P 

## em OF

# = OF amDREN ACl'IVE INGREDIEN'TS Alkyl (50% 

### C,A' 40% C,,( 10% C, 6) 0.28% d:iJnethyl Milzyl anm>O!\i.1.lIIl chlorides INERr INGREDIENTS 99.72% 

### TarAL 100.00%
25 

### wipes 7 1/211 X 10"

• VISU1ILS FOR EAa! I.OCATION WILL BE SlmN IN EACH EQX.Kitchen, Bath1:Calls 

# -= Nursery walls, Floor!l ToUets, sinks Slla.Mrs, ""'" TUe, :Eni'mel, Porc:cl.ain 

### .,.",.,.,. cans, Dia>er Pails



# • Hew I¥sol sanitizin; Wipes are the o:::r'M!nient way to clean, disinfect, an::l dec:dorlze ill ycor ha.1seho1d su:rtaees. Each prew1sttmed di..sp::sab1e wiJ,::e is treated with a 5pClCial dis:fn!ectirq cleaner that actu<U.ly kills germs - even the geDIlS that cause cdcrs

- yt:U usa it. No bottles, no spon;es, no mess. U:fective cleaning has nuver been taster or easier. UrJplu; small ' electrical bet:cre cleanin;. Not:rec:c:mnerrla: for polished or**~surtaces. ~FCROSE:**  It is a violatiat ot' Fe::!eral law to use this projlJct in a manner in::onsistent with its lal:elin;. Pull up bb an:! :t8Ilt:Ml 1al:g& o:JIa!r. Insert trlan;ular locp

_ slits jn cecee,

__ fimt sbBaI: :in C&1bllr at mll

. locp.

- """". Fulllocp bode

_ Pull II!llJCb 8be8t qt an:! a1 iqhtJy to th8 aida. Alw-yu snap lid se::mely shIt ketween uses to prevent. lOOisture loBs.

• lDJSm)ID**~~:** S.i:mply wipe surtaces clean. No rinsing requ.ired.

•**~:** It' SI.Idaces are extremely cliJ:ty, :folla.l cleanin; directia'lS tiIst:; then wipe: and let stan:! 10 lD:1nItes.

• M:lID Mm Jo!IIL!W PRE'JENrIQf: To prevent mold ard**~,** wipe and :repest**~icatiat** as necessatY•**~~:** HAZ1lRrS 'l'O JDWiS AND ttMESrIC .AN!MALS C1lU!'ICN: May cause eye irritat!at. Avoid ..xmtact.
....it\:) eyes. Avoid eattaminatic:n ot' teed.. I):) txT:. -ioc or vecre near heat or q:len .tlame. SD\1'EMENI' OF**PRACl'ICAL~:** U eye o:ntact occurs, wash hnlllOOiately with water. It' in'itatian cceces,**-3'~';** medical attentim. Sl'CAAGE: St:m:a 

## morl.gi.Ml a::nta.iner in eeees inzvressfhla to SlIl!ll1 children. stare canister in a CXXJl pl.aca. IJI.SF:SAL: to not reL1lMII eapt:.y container. wrap 

### am lUt In '=sh. 

### mm & FINK :m:JWCl'S DlVISIQ{ OF s:cE:R!JlI; ao:;, INC. K:lnVAI.E, W 01645 EPA REXi. 00. 

### m-XX, EPA EST. m-JLo.01, W-1 (see Bot:taD) 

# 0\\\\1\1\\

19200-04800

# III

May 8, 1986 

# Lehn &

# Fink Products Group, Sterling DrugInc. 225 SummitAvenue,Montvale, New]ersey07645/201573-5700

Mr. John Lee (PM-31) Disinfectant Branch Registration Division (TS-767) U.S. Environmental Protection Agency 

### 1921 Jefferson 

### Davis Highway 

### Crystal Mall, Building 2,. Room 252, Arlington, VA 22202 

### Subject: LysolR Brand Sanitizing Wipes 

### EPA Reg. No. 777- Dear Mr. Lee: In support of a new product registration for the above product, we enclose the following:



### 1. Application for Pesticide Registration #8570-1 (Rev. 5-81) 2. Formulator's Exemption Statement, Attachment A 

### 3. Certification with Respect to Offer to Pay, Attachment B 4. Data Requirement for Owner Submission 

### 5. Confidential statement of Formula #8570-4 6. 158.20 Attachments 61-2 statement of Composition 61-3 Discussion of Formulation of Ingredients 62-3 Analytical Method for Enforcement Purposes 63-2

- 63-4 )Attached Bulk Monograph 63-7 

### & 63-18) 

### 63-17 Storage Stability 

### 7. 158.135 81-1 

### 81-2 81-4 81-5 81-6 

### Toxicology (2 copies) Acute oral LD-50, rat
- liquid Acute dermal LD-50

- liquid Primary eye irritation, rabbit

- liquid Primary dermal irritation

- liquid 

### & wipe Dermal Sensitization

- wipe

cont'd

....

### Mr. John Lee (PM-31) -2- 

### May 8. 1986

8. 158.135 Confirmatory Microbiological Efficacy (2 copies)
9. Five (5) copies of the Prototype Label
As usual. if any questions arise on this application, please call me directly at 201-513-5188 so we can quickly resolve them. Thank you, Sincerely,

Deirdre O'Connor Director Research Services DOIC/ds attachmentsFILE SYMBOL 

## 77'7-11I. REGISTRATION NO. 

# CONFIDENTIAL STATEMENT OF FORMULA ENCLOSED

ji DATE SUBMITTED BY 

### (Il SUBMITTED APPLICANT BASIC SUPPLIER 

# 1-30-g£ c-> 

# Do Not Write Comments, Formula,orParts ofFormula on This Envelope

NOTE

• It shall be unlawful-for any person 

### to use for his own advantage or 

### to reveal. other than to the Secretary, or officials or employees ofthe 

### United States Department ofAgriculture or otherFederal agencies, or to 

### the courtsIn responseto a subpoena, orto 

### physicians, andIn emargencles to pharamaclsts and other qualified persons, for use In the preparation of antidotes, in accordance with such directions as the Secretary may prescribe, any information relative to formulas of 

### products acquiredbyauthority ofSection4 ofthe "Federal Insecticide, Fungicide, andRodenticideAct" ,

USDA-ARS

### Page is not included in this copy. Pages through 

# 0U1l2 are not included in this copy.

The material not included contains the following type of information: Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control**pr~cedures.** 

### Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label.



### __-,v/

__ The product confidential statement of formula. Information about a pending registration action. FIFRA registration data. The document is a duplicate of page{s) The document is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your**~·equest.**

# o FllODVCT

### JIIK'R"OOlI'I1'1OllIlCI! 

### INI'OIlWA11ONIS NOTINCLUOED 

## CHEMICAL NA.t\1EfPESTICIDE CHEMICAL CODE (PCC) REQUEST FORM'**~«-_.;q ~;S(**  (}-

## REQtrrsrDATE:2/31(~



## T> FOOI.{,_,

_ MAlL CODI' 

## ''is-0_:C IOIV.jlll/stC·1 

### ?/.-J3**~'fl R£Q~~OR**  NAl>m TEL., 

### dEDI. ' CSF ATTACHED: DYES U CSF is attached complete Item k aed the chemical name in Hun ·8. ;a..NO U CSF is Dol attached complete Items A tborough C. ,A, INFORMATION REQUIRED:

.....r;:w« A.rfl1W/t

### Celo,..,. O-Provide pee aDd Tcleraace**E~cmptio~** Status,For Feed-Use Inert logi:'tdicnl(s)

. 

## .0 Provide 

### pee for NOD-Food Use Inert logndicat (5)**O~vidc** Pee for Active:lngndiut(s)

.

## lNEKI'.INGUDulNrJNfORMtma... ' '0 Provide PCC-Cor Dye
. _ ........-n:**~JM'JtlD£D**

. .JlfDctcrminc ifFragrance is Acceptable for Use in**t~-rmu1atioD** -- - 

### '0 Other (Describe}:**_:-_:---~-_:--_:-~** B. INGREDIENT INFORMATION: log:redicDt No.1': Cbcm. Name: Trade NlImc: CAS Reg.

### No~: '
------- Ingredicnt**No~** .3: I.ogredictlt No.**~:** . Cbcm. Name: Cbcm. Name:

Trade ·Name: 

# -============ CAS Reg. No.: - _ Track Name: CAS Rei. No.:**lt~,,'''''** 

# J

# 01 

# --='=,- J.-Y9J-**7ttt;~i** l-;/V0 

# cd;**F.'=~** Food·U(e P-estieide: 

### 0 YES }i):NO

lDgredknt No. oC: Pee: TOt- STATUS: OTBERINF"

# ""~' •.;

# ._l?-~ 

# 14 PO**~lltNo.~** PCC: TOL. STATUS: OTBERINF" C. PESTICIDE PRODUcr INFORMATION: EPA R-.. No II. Symbol,

# _-:,.:;--:;.,-/,,& ProductN....,**R~gist:rant:** "7"'1 

### v i-

. Perceet.Ia Formulation (Fot Fragrancc/Dyu onl)'):

INFORMATION REPORTED,

## PCC~grt:dieDt Ko. 1:

_ TOL. STATUS:**~--_** OTHER INF.,**lo~ient** No.3: 'pcc, TOL. STATUS:

# '-==:;=======:::;::= OTHER INF. '

_ . C<.ffi." :

# L-1:~'{j1J- 

# .r-.A-./

.------.·--,-- . rn! '(

### Page is not included in this copy. Pages

### ~6L through 

### pZOS-are not included in this copy.

The material not included contains the following type of information:

__

## ~~ __ Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control**pr~cedures.**



### ______ Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label. The product confidential statement of formula. Information about a pending registration action. FIFRA registration data. The document is a duplicate of page(s) The document is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your request.

### Page is not included in this copy. Pagesc2tJf; through

## (~'l are not included in this copy.

The material not included contains the following type of information:



# , V---Identity of product inert ingredients. Identity of product impurities.**~·Description** 

### of the product manufacturing process. Description of quality control**pr~cedures.** 

### Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label. The product confidential statement of formula. Information about a pending registration action.

______ FIFRA registration data. The document is a duplicate of page(s) The document is not responsive to the request.

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### Page is not included in this copy. Pages 

## :f2.t;'t through 

## e?/tJ are not included in this copy.

The material not included contains the following type of information: Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control prqcedures. Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label. The product confidential statement of formula. Information about a pending registration action. FIFRA registration data. The document is a duplicate of page{s) The document is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your 're

### ques t;

.

### Page is not included in this copy. Pages 

# ,:£11 through 

# ,21.3 are not included in this copy.

The material not included contains the following type of information: Identity of product inert ingredients. Identity of product impurities.

__

## -O~_._ Description of the product manufacturing process. Description of quality control**pr~cedures.** 

### Identity of the source of product**ing~edients.** 

### Sales or other commercial/financial information.

_____ A draft product label. The product confidential statement of formula. Information about a pending registration action. FIFRA registration data. The document is a duplicate of page(s) The document is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your r-equeet; .

### Page 

# d/tfis not' included' in this copy. Pages through are not included in this copy.

The material not included contains the following type of information: Identity of product inert ingredients. Identity of product impurities. Description of the product manUfacturing process. Description of quality control prqcedures. Identity of the source of product ingredients. Sales or other commercial/financial information.

_____ A draft product label. The product confidential statement of formula. Information about a pending registration action. FIFRA registration data.

___ The document is a duplicate of page (s)

___ The document**~s** 

### not responsive to the request.

The information not included 

### is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the r-esponae to your z-eques t;

.

### Page is not included in this copy.

# pages~ through

# 42~;r are not included in this copy.

The material not included contains the following type of information: Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control**pr~cedures.** 

### Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label.

## ~The product confidential statement of formula. Information about a pending registration action.

______ FIFRA registration daca. The document is a duplicate of page(s) The document is not responsive to the request.

The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your**~·equest.**