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UNITIL >fATES ENVIRONMENTAL PROTECTIOk AGENCY

FEB 11 1001

Reckitt Benckiser, Inc.

1655 Valley Road

Wayne, NJ 07Q47

Subject: Lysol Brand Pre-Moisten Bathroom Touch Ups Disinfecting Wipes

EPA Reg. No. 777-68

Dear Mr. Paolella:

You recently submitted a label amendment for the subject product which we responded to

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 of this product

to sanitize hard non-porous surfaces that phrase 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 your use 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 clean potable water rinse after using

this product."

Ifyou have auy questions conceming this letter please me at (703) 308-6233.

/

OFFiCiAL FILE copy

h I

JX:

Velma Noble

Product Manager 31

R I to M tB

EPA Fonn 1320-fA (1f90)

egu a IT anagemen rauc

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.................. ................. ................. ................ ...............•. ................. ...............-................. ...._..
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UNIT. STATES ENVIRONMENTAL PROTECTI, AGENCY

Reckitt Benckiser, Inc.

1655 Valley Road

Wayne, NJ 07047

FEB 09 2001

Subject: Lysol Brand Pre-Moisten Bathroom Touch-Ups Disinfecting Wipes

EPA Registration No, 777-68

Amendment Date: 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 per the Agency letter dated May 4, 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 of Formula or 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 exterior ofthe toilet for which efficacy data has not been

submitted to support disinfection or sanitization claims. This product is limited to disinfecting or

sanitizing the exterior ofthe toilet or the toilet seat. You must revise the label accordingly.

Additional Label Recommendations

Page 1:

1. Under the surface section, the surfaces, "tile" and "porcelain," need to be qualified as

hard, non-porous by stating "glazed tile" and "glazedporcelain." In order to prevent

misuse ofthis product, the surface "diaper changing counters" should be moved to the

third column, so the surface can be listed on the same line.

p~M R,cycl,d Paper OFFiCiAL FILE COPY

The phrase, "and other hard, non-porous surfaces (anywhere you travel)," must be deleted

because the claim is too broad. Instead, you should revise the claim, "the quick and easy

way to (clean and) disinfect (sanitize) " by adding the phrase "the following hard non

2.

EPA Form 132o-1A (119O)

, , , - , ," COMCURR!MC!S

SYMBOL,: ..7.fil.P..~_................_ .................. ................. .................. ................. ..._............ ................. "'"NAME llli¥dt!.4IJf:., . OATE l~oi" .................................. ................ ................. ................. ...............-.................

,
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) hard non-porous surfaces such as (toilet seats) (toilet

exteriors)." (Remove the parentheses from disinfect which provides consistency with

similar claims on the label).

2. The 16th claim must be revised to state "Disinfects hard, non-porous food contact surfaces

such as counters and tables. After treatment rinse with potable water. Do not use this

product on utensils, dishes, or glasses.

Page 3:

1. Under the list of bacteria and fungi, Trichophyton mentagrophytes should not be listed in

parentheses; instead the disease it causes, Athlete's foot fungus should be placed in

parentheses. .

2. Under the 2nd list ofsurfaces, the surface, "porcelain," need to be qualified as hard, nonporous by stating "glazedporcelain." 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 must be 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. Under the "Directions for Use", you should move the instructions on how to open the

package to appear before the "To clean" directions.

3. You should have separate "to clean" directions for this product because the directions are

confusing when linked with the sanitizing directions. The heading should state "To clean

hard nonporous surfaces such as toilet seats/exteriors."

4. The sanitizing directions should have the heading, "To sanitize non-food contact

surfaces" and the directions should state "use afresh towelette to thoroughly wet surface.

Allow surface to remain wetfor 30 seconds. Allow to air dry. For heavily soiled

surfaces, repeat sanitizing directions."
UNITED S rES ENVIRONMENTAL PROTECTION A ~CY

COHCURR!HC!!$

SYMBOL

.................. ...............-................. ................. .................. ................. ...-............ .................. SURNAME

I

.................. ................. ................. ................ ................. ................ ...............-............•....

DATE

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 hard nonporous bathroom surfaces including toilet seats/exteriors." The directions should state

"Use afresh towelette to thoroughly wet surface. Allow surface to remain wetfor 10

minutes. Allow to air dry. For heavily soiled surfaces, repeat disinfecting directions."

6. The phrase, "flush or toss the wipe away," contradicts the instructions, "Do not flush

down toilet." You will either need to explain to the Agency your intentions in using

contradicting phrases 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. Under the disinfection directions, you must add the following:

For food contact surfaces such as counters and tables, rinse with potable water. Do not

use on dishes, glasses, or utensils.

3. Since this product may be used in hospitals, nursing homes, dental/medical facilities on

examination tables, in operatories, on wheel chairs, etc., the following MOU language

from PR Notice must be added to the label.

This product is not to be used as a terminal sterilant/high level disinfectant on any surface

or instrument that (1) is introduced directly into the human body, either into or in contact

with the bloodstream or normally sterile areas ofthe body, or (2) contacts intact mucous

membranes but which does not ordinarily penetrate the blood barrier or otherwise enter

normally sterile areas ofthe body. This product may be used to pre-clean or

decontaminate critical or semi-critical medical devices prior to sterilization.

You should submit five (5) copies ofthe revised label addressing the above comments for

the Agency to review. If you have any questions regarding this letter please contact Jacqueline

McFarlane at (703) 308-6416.

,sr;:1WJ»-

~~lmaNOble Product Manager (31)

Regulatory Management Branch I

Antimicrobials Division (751DC)
UNITED S rES ENVIRONMENTAL PROTECTIOH A .~CY

1

EPA Form 1320-1A (1190) OFFICIAL FILE COPY

COHCURRI:NCI!:$

SYMBOL I

......•....••............_......- ................. ................. .................. ................. ................. ................. SURNAME

I

.................. ................. ................. ................ ................. ................ ...............-................. DATE

.
r Please read instructions on reverse before co, 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)

Lysol Brand Pre--Moistened Bathroom ToucnUps Disinfecting Wipes

5. Name and Address of Applicant (Include ZIP Code)

Reckitt Benckiser Inc.

1655 Valley Road

Wayne, NJ 07474

o Check if this 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

o Other Printed on package

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

DYe,' 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 directly belOw for identification of individual to be confacted, if necessary, 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

under applicable law.

6. DaleApplication

Received

(Stamped)

3. TItle

Senior Regulatory Affai/s Specialist .,

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 of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room 266A, Crystal MaU2

1921 Jefferson-Davis Highway

Arlington, Virginia 22202-450 I

Attn: Velma Noble PM-31

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

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 of the 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.

};,

'ncereIY, B If)

r~aolela I -'---- ~~ 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

16 Individually 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) (Summer Fresh) (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

DIAPER CHANGING 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

Pet Areas

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» • .'. ii"•• •

• • ••••••

• • • • •• •••• •

• • • •• •• ••

•

/0•••••• · ., • •

•••••• • • .. •••••• • • ••••• Note: Brackeled () lnformalion is oplionll! text, Text separated by a comma ( , ) denotes and/or oplions. •••• • • ••• •
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%) of household germs - and / or- bacteriaand/or- viruses-v -and/or- fungi -and/or- mold.

Kills (more than -or- even greater than -or- » 99.9% of household 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-porousfood contact 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.

• • ••••••

•

• • ••••••

• • • • ••••••

•

• • · ., •• ••

•

•••• • • ••••

••••

/

' . . ., • •

• ••••• • • .. ••••• • • •••••
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: 10/03/00

3

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, Diaper Changing 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, counter tops

(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, or diaper changing stations. •

• 0

o .,

•• ••

•

.

•••••• ., o 0

•••••• • • .. ••••• o •

••••• Note: Bracketed () infurmajlon is optional text. Texj separated by a comma (,) denotes and/or options. •••• o •

••• • ••••
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 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 of concern.

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 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 (~heatu1 ,,\Wt a ~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

towelette to 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) (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.

••••• • • "....

•••••• • •• • •

•••••• • • ..

oF)

I?

•

•• ••

•••• • • ••••

• • ••••••

•

• • · . "

NOIe: Bracketed () information is optionaltext. Textseparated by a comma ( ,) denotesand/Or options.

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~. •

••••••

• Peal back the front label slowly. Remove towelerte as needed. Reseal pouch by firmly running thumb o~r

e label.

l

•••••
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 of Human Immunodeficiency virus type I (HlV-I) (associated with 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 10 minutes.

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 comer of wipe 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 FOR PERSONAL HYGIENE.

To Disinfect Hard Non-Porous Surfaces: Use a fresh towelette. Wipe surface and allow to remain wet

for 10 minutes. 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',<-".. Dr, t (l'-'''1f l ~,"<;. ,.:, '" ',~, • ,; -,

'co ~;.(j(' 'S"'£. ·r·,,·' ;",I';\:'-S~.,..;:,:· \'f-~_'."';"i(.,';, <,A'.,."'US

••••• • • •• •••

•••••• • • .. .

•••••• ., • •

•

•

•••• • • ••••

• • • •• •• ••

• • ••••••

•

• • •••••• •

• • ••••••

•

Note: Bracketed () information is and/or options.

*Not recommended for glass, mirrors, polished or bare wood surfaces.

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 or detergent 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.

••••
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 of eye 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: Dispose of wipe 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 of dry 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

Text separated by a comma (, ) denotes and/or options.

o 0

••••••

o

o 0

••••••

o

o

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••••••

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•••••
Lysol Brund Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes

EPA Registration Number: 777-68

Page:

Revised: 10/03/00

New"

Lysol ® Brand

Pre-Moistened

Bathroom

Touch-Ups

Disinfecting Cleaning Wipes

Contents

16 Individually 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) (Summer Fresh) (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

GAS STATIONS

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

Diaper ChangingS+II-+'o<:s

Counters

Table Tops

Toilets, Sinks

Showers, Tubs

Tile, Enamel

Porcelain

Garbage Cans

Diaper Pails

Counter Tops

Nursery

Telephones

Cabinets

Storage areas

Pet Areas

High Chairs

And other hala 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

*WilI only be used for 6 months from date of introduction

(Resealable Pouch Inside)

Keep Out ofReach

OfChildren

CAUTION: See

Panel for additional

Precautionary StatelJlent~·. •••••

•

• • ••••••

• • • • ••••••

•

• • • •• •• ••

•

.

•••••• ., • •

•••••• • • .. ••••• • • ••••• Noie: Bracketed ( ) Infbrrnaiion isopitcnaltexr. Te:xi separated by a comma ( , ) denotes and/or options. • •••
Lyse! Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes

EPA Registration Number: 777-68

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).

Starts killing (bacteria) (germs) on contact.

Kills (more than - or- even greater than - or- » (99.99%) of household germs - and / or- bacteriaand/or- viruses** -end/or- fungi -and/or- mold.

Kills (more than --or- even greater than -or- » 99.9% of household 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 a mildewstat and will effectively inhibit the growth ofmildew on hard non-porous surfaces.

Disinfects hard non-porausfoad contact surfaces. A,nn~, ",!'';Ll<fi'i ai';")',' , 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:

Note: Bracketed () information is option

• • •••••• /1 •

• • ••••••

• • ••••••

• • • • • • •

•••••• • ••••• • • • • • .. • • • ••••• • • .. • • • ••••• Jons. •••• • • ••••

••••
Lysol Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Wipes

EPA Registration Number: 777-68

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 Immunodeficiency Virus Type I (HIV 1)

Influenza A2 (Japan)

Optional Disinfectancy Related - bullets/bursts/sentences - Front or Back Panel

Page:

Revised: 10/03/00

3

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, 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) (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) (aqcl other bard non_porous SlJrfuces (a~Waefe Y"O baQeI).

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 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 on,g••:.

"go" in restaurants, public restrooms, public telephones, or diaper changing stations. •

• • • •• •• ••

•

.

•••••• ., • • ••••••

•..•

••••• • • ••••• Note: Bracketed {) informal ion is oprlonaltext. Text separaled by a comma L, ) denotes and/or options. •••• • • ••••

••••

• •
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 of concern.

ALTERNATE LANGUAGE

The (fast) (convenient) way to (clean) and t\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, 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) (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. r'TO (CLEAN) (AND) 5 ,,_ ii, HARD SURFACES (INCLUDING TOILET SEATS): Use a fresh

( towelette to wipe surface. (Flush) or (Toss) dirty wipe away.

J ,0 s, ....o vn ae :

Allow surface to remain wet for 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 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)

I~

••••• • • •••••

•••••• • • ..

••••••

• •• • •

•• ••

•

•••• • • ••••

••••

• • ••••••

•

• • • ••

Note; Bracketed( ) informalionis oplionallex!. Text separaiedby II comma (,) denotesllI1d1or options.

Pull up tab and remove large cover. Remove inner tab loop from cover hinge. Insert loop into opening. •

Thread first sheet in center of roll through loop. Replace cover. Pull loop back through opening. Putlolt<tC'h- • sheet up and slightly to the side. Always snap lid securely shut between uses to prevent moisture los~. •

••••••

• Peal back the front label slowly. Remove towelette as needed. Reseal pouch by firmly running thumb O'4f:r

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 of Human 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 center ofthe roll and insert corner of wipe 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 FOR PERSONAL HYGIENE.

• ••••

• • •••••

•••••• • • ••

•••••• • •• • •

•••• • • ••••

••••

•

• • • •• •• ••

•

• • ••••••

•

• • ••••••

•

• • ••••••

•

Note: Bracketed () lnfbrmation is ~ndlor options.

*Not recommended for glass, mirrors, polished or bare wood surfaces.

To Disinfect Hard Non-Porous Surfaces: Use a fresh towelette. Wipe surface and allow to remain' wet

for 10 minutes. Toss dirty wipe away. Do not flush down toilet. To disinfect heavily soiled surfaces,

repeat with a clean towelerte. ~,.j \"11.:1-1 US<'. \.> IN Q.(>::f>F,.' i""':"":,. Dr, c ()"il\.' c; "-.".',: -::.-. ''<

\X)~,\c!' '.Y:'(.'-',j.l "".,:.<;..;S, ,;c' ,ij'-' •• "'... ..-..-",...;;",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 or detergent 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 of eye 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: Dispose of wipe 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 of dry 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 of Reach

OfChildren

CAUTION: See

Panel for additional

Precautionary Statements

Net Contents: One Towelette

Reckitt Benckiser Inc.

1655 Valley Road

Wayne, New Jersey 07474

Text separated by 3 comma (,) denotes and/or options.

• • ••••••

•

• • ••••••

• • • • •••••••

•

• • · ., •• ••

• •••• • • ••••

••••

••••••

• •• • •

•••••• • • •• ••••• • • •••••
Revi ev e r 10

SUblllis s ion No.

Data Package No.

~t{7031g

D U8~;;J--

_ ,r

L!(C~ Certificat.ion ()+:-,,","/_' .. __ J... t,." . .:

L!(S) Service Person

I I (R) Non-resident.ial 10

Use Oni1"

/ I (N) Hot.-~PliC:abll/)C~1; / " (2) Uncondit.ional

/ / (R) Restrict.ed

" / (N) Not ClossifleQ

1011 EPA P.ec:eiveod Date:

1C),310'1 ~I -c Yll

o (6) Owner Sul:mission .

.I I (7) Total Sul:mission

o (tIJ ~lecUve Kethcd

/ / (R) Res~ric:ted

1 I (G)' General

rEI Date.on ·~lieat.ion:

10, 101110 0 I . 1'0 ~.- \"P.

180!lIethod of Suppon.

I / (1) Clt~All

/ / (4 J Not Applicabl.

-; / m Not S"""i tted

lEI proposed C1assif kat.ion: I30I Final Clus~ticat.ion:

. I 120 I Rl!9ist.ratlonfIYpe:

f. / (11 Cond i t.iOl1al

CODI~ m~ FOR APPtICATICNS roR 1IS'TR,l,TICN/NIDm-\rnTS

file SY"'X>lIR"'l' No. 117-?~ f>i.12L- Action C<Xl<

110 I Descnptor (!vneoo/ResW:nisiOlU only)

15 I· Int.rast.at.e Call-in I / (Y) Yes 1151 Olild-resist.ant

- Pac:k.aqin;·

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UNITED STAT ENVIRONMENTAL PROTECTION: AGEl

~lAY J 5 iOU'

Household Products Division

Reckitt & Colman Inc.

1655 Valley Road

Wayne, NJ 07474

ATTENTION: Bruce Paolella

SUBJECT: Lysol® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting

Cleaning Wipes

EPA Registration Number 777-68

Amendment for Alternate Formulations

Your Amendment Dated: March 1, 2000

EPA Received Date: March 1, 2000

This is to acknowledge receipt ofyour amendment to add alternate formulations for this

product. The Confidential Statements of Formula (C.s.!'s) for the Alternate Formulations

! (Formulas #656-130, 656-131, 656-132, and 656-133) dated 3/1/2000 bas been reviewed and

have beenfound to be acceptable withthe following conditions.

The Agency has revised the CSFs for formulations 656-130, 656-131, and 656-132 to

include the name associated withReg. ' In addition based on our

phone c~nversation with you we have corrected formulation 656-133 i6 include the following

address for - . , Makethese same 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 Tracy Lantz at

(703) 308-6415.

OFFICIAL. FILE COPY

rJi~!# Velma Noble

Product Manager (31)

Regulatory Management Branch I

EPA Form 1320-1A (1190)

COKCURR!!HCzfuxtimiwvbials Division (75106)

SYMBOL. t 7510C:T. antz:5/12/00: 177-68c .

SURNAME)

:~W~::: ................. .................. ..•.•••••••u ........ .................... ....'......,.......... ................... .................

DATE - i .................... ................. ................... .......... ....... ..'-................. .................- .................. ..

.' '.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTiON, PESTICIDES AND

TOXIC SUBSTANCES

SUBJECT: Product Chemistry 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: Velma Noble PM 31

FROM:

THRU:

THRU:

Alex Traska, Chemist

Product Science Branch, CT Team

Antimicrobials Division (751DC)

Karen P. Hicks, CT Team Leader

Product Science Branch

Antimicrobials Division (751DC)

Michele E. Wingfield, Chief

Product Science Branch

Antimicrobials Division (751DC)

BACKGROUND:

This submission, for the 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 noted in the prior review have been adequately

addressed.

2.The requirements ofPR Notice S1-2 were satisfied. The nominal concentration

ofthe active ingredient given in the four(4)Alternate Formulation CSFs agreed

with the percentage declared on the label.

3.Upper and lower certified limits for both the active and inert ingredients are

acceptable.

4.All active" and inert ingredients utilized cleared for use in pesticide formulations.

S.All other elements ofthe CSF were acceptable.

RECOMMENDATIONS:

This submission which addressed the deficiencies noted in the February

22,2000 Agency letter, is accepted.

4/13/00 AT
Form 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'ltON IS00l"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 chlor
March I, 2000

Document Processing Desk (AMEND)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room 266A, Crystal Mall 2

1921 Jefferson-Davis Highway

Arlington, Virginia 22202-4501 PIIOOIlCl'fIoIilBEDII'.Nl501lIlCE 1NPORMAJ'ION ISNOT 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 have been corrected to and are now

consistent with the certified limits of 656-130 and 656-131.

4) I have revised the Formulator's Exemption Form to reflect all the sources ofthe

active ingredient.

5) We have changed the Product Name on the CSF's to reflect the name indicted on

the original registration: " Lysol Brand Pre-Moistened Bathroom Touch-Ups

Disinfecting Cleaning Wipes."

I thank you 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 of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room 266A, Crystal Mali 2

1921 Jefferson-Davis Highway

Ariington, Virginia 22202-450 I

Attn: Velma Noble PM·31

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

EPA Registration Number 777-68

Non-Notification label changes as perPR-Notice 98~10

Dear Velma:

Reckitt& Colman Inc. has made some non-notification corrections/changes to the master

label for the above product and we are confirming those changes withEPA. Below is an

explanation of what 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 in brackets the phrase (anywhere

you travel) to allow us the option ofusing that phrase. We have added the phrase

(Resealable Pouch Inside).

2) On page 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 with marketing 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) 633·3633
4) In the sentence "Forgeneral cleaning and disinfection (sanitizing) hard nonporous

surfaces." We have bracketed the words (cleaning) (and) (disinfecting).

5) We removed "Canister Only" from the last paragraph.

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 bracketed the words (Flush) (Toss), the phrase (Flush dirty wipe away). We

added the phrase (Do Not Flush Down Toilet) and have bracketed 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 and Disposal statement in

the section for "Canister Only"

The remaining pages have no changes made to them. Since the changes are consistent

with Non-Notification changes outlined in PR-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 for Pesticide Registration Form 8570-1, 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 (ongm ) PP py

FO/n! Approved, OMS No. 2070-0060, Approval expues

A Fonn 8570 1 (Rev. 8 94) PrevIous editions are obso

Please read inslructions 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 Check if this 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 ProductWinBe 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 of Net 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

D Stenciled Pre-Printed plasticwraprpre-printed Cardboard box

Section -IV

1. ConlactPoint (Complete items directly below for identification ofindividual 10be conlacted, ifnecessary, 10process this application)

Name Title Telephone No.(Include Area

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 and complete. I Received

acknowledge that any knowingly falseor misleading statement maybe punishable byfine or imprisonment or both (Stamped) under applicable 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 Co
t

Rev i eve r 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 ':-.; ", J

i '-t'I. (;(, -"

1401 Date Received by

1t1,;.(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.i t ted / / IS) Selective Kethod

Revieowet"S Req'I.lested:

CH

EF

PL

DE8

SDEa

78

I \

! I, I • i ! •

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_"0 2At \::;,

EFGS ---'--..........--------.3;(.,

11151 fIlW- ",".;on.e/I)

AC'I1CN Cede ,y.

75-0l\'t R£SP:l-Ise CO£: CArt: L/('tl re s- / j(NI No
UNITEO ST ES ENVIRONMENTAL PROTECTION A' ICV

MAY 0 4 1000

Reckitt & Colman, Inc.

1655 Valley Road

Wayne, NJ 07474

ATTENTION: Bruce Paolella

SUBJECT: Lysol® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting

Cleaning Wipes

EPA Registration Number 777-68

Your Non-Notification Dated: February 2, 2000

EPA Received Date: February 4,2000

This is to acknowledge that the Agency is in receipt ofthe changes which you have

specified be added -to your labeL After reviewing this application, it has been determined that

these changes do not comply with non-notification as per PR Notice 98-10. These label changes

must be resubmitted to the Agency as an amendment.

Included in the changes on your label are modifications to place parenthesis around the

words "disinfect" and "disinfecting." The PR Notice specifies that only claims for non-pesticidal

effectiveness may be modified by.non-notification. These are pesticidal claims.

In addition the Agency is unable 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 ofFormula.

COHCURRI!NaS

::::~ .1_~tg~·7 '..-.' _ .,. -...~ .., .

DATE -3- ~."".: ~............. ·__···~~;;:I~~·::~:·:~::

EPAForm (1190) Prbskdm 1W:ycltdPa~r
UNITED ST ':S ENVIRONMENTAL PROTECTION At iCY

Your references to flush or toss the product and then the reference "Do Not Flush Down

Toilet" are not in agreement. Explain to the Agency your intentions in using these contradicting

phrases. Are there certain conditions under which the product should not be flushed?

Should you have any questions concerning this letter, please contact Tracy Lantz at

(703) 308-6415.

Sincerely,

Velma Noble

Product Manager (31)

Regulatory Management Branch I

Antimicrobials Division (751OC)

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

EPA Form1320-1A (1190)

• COKCURR!!HCl\:S

SYMBOL. . .

........ •.•..•.... .................-...............•.. ...............--.. ....................... ....:.•....,... ..... ........... ....... ........._...... SURNAMe. ... ....; ..• ...... ..•....•.•........ ................. .................. ..........•....... .............,....... ......._.•......-.................. DATE . . . OFFICIAL FILE COPY
NOTE TO THE JACKET

777-68

5/3/00

The following are concerns/comment on 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. John Newland 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

also add (Resealable PouchInside). You may modify thetwo sentences asfollows:

"The quick and easy way to (clean and) disinfect (sanitize)"

"And other hard surfaces (anywhere you travel)." ASK EMILY

Joh~ .. "",C:J.lI.f ~e(.\ a~ 0.14.- I-yd S.,.-lk.s ~~.-..\- 2. On page two you may include in parenthesis onlythe following information inthe first and "J~.

second statement asfollows:

"Ready to use. convenient; the quick and easywayto (clean and) disinfect (sanitize) toilet

seats (and otlterHJard surfaces." ASK EMILY

"The quick, easy way to (clean surfaces and) kill (household) germs."

YQU may remove thelanguage referring to canisters.

3. On page three you mayinclude in parenthesis onlythe following information inthe first set of

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'#\

"Use them on bathroom surfaces, toilet seats and telephones in malls, 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 the language section on pagethree are acceptable:

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

"New" Lysol® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes

arethe convenient wayto (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) wayto (clean) (and) disinfect (sanitize) your household surfaces."
"Each pre-moistened disposable wipe (is treated with a special cleaner that actually)

kills genus..." ASK EMILY

"Effective disinfecting (sanitizing) has never been faster or easier."

"Unplug small electrical appliances before (use) (cleaning) disinfecting (with this

product.)"

5. On pagefour you may delete thephrases "Canister Only" and "Pouch Only." You may also

put parenthesis around the phase (hospital type).

6. On page five you may delete the phrase "Canister Only."

You are required to submit an amendment and updated label to add the following changes

to thelabel as these changes are not permitted as non-notifications. These changes willbe

reviewed as and amendment and comments to the label may be necessary.

1. TheAgency is unable to verify that the scents listed onyour label (Citrus, Summer Fresh,

Spring Waterfall, and Country) are actually used in a formulation which has been accepted for this

product. Identify to the Agencywhich scents areassociated with which fragrances on anaccepted

Confidential Statement ofFormula.

2. Only non-pesticidal claims may be modified by non-notification. All references to placing the

words disinfect and disinfecting inparenthesis must be made by amendment.

3. Your label may list (toilet seats) in parenthesis, but not (toilet) and (seat). A unqualified toilet

is considered the entire interior ofthe bowl and your label does not provide directions foruse for

this surface.

4. Your references to flush or toss theproduct and then thereference "DoNot Flush Down

Toilet" are not inagreement. Explain to the Agency your intentions inusing these contradicting

phrases.

j

Tra~tz Team 31

777-68n2
Box (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) (Summer Fresh)(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 hard surfaces (anywhere you travel).

• Quick

• Convenient

• Portable

*Will only be used for 6 months from date ofintroduction

(Resealable Pouch Inside)

37
Box (Pouch) (Canister) Label

777-68

(Front Label Cont.)

ALTERNATE LANGUAGE

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.

ACTIVE INGREDIENT:

Alkyl (50% CI4 40% C12 10% C12)

Dimethyl Benzyl Ammonium Chlorides

INERT INGREDIENTS

TOTAL

0.28%

99.72%

100.00%

Keep Out OfReach

OfChildren

CAUTION: See

Panel for additional

Precautionary

Statements

Does not include weight ofdry wipe

EPA Reg. No. 777-68

EPA Est. No. 777-IL-I, 777-NJ-2, 052631-NJ-00I

(See Bottom)

2
Box (Pouch) (Canister) Label

777-68

(BACK)

New* Lysol Brand Pre-Moistened Bathroom

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 bacteria may be of concern.

ALTERNATE LANGUAGE

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,

examination tables, 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 Bathroom Touch-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.

Each pre-moistened 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 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.

3
Box (Pouch) (Canister) Label

777-68

(BACK CONT.)

Directions for Use: It is a violation offederal law to use this product in a manner

inconsistent with 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 wet for 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 OTHER BATHROOM SURFACES: Use a

fresh towelette according to directions above. (Flush) or (Toss) dirty wipe away.

(Do Not Flush Down Toilet)

Pull up tab and removed 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 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

4
Box (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 of human immunodeficiency virus type I

(HIV-I) (associated with AIDS).

Special instructions for Cleaning and Decontamination Against HIV -1 of

Surfaces/Objects Soiled with BloodIBody 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 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 fluids should be

autoclaved and disposed of according to local regulations for infectious waste

disposal.

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 (First Aid):

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 at

least .15 minutes. Call physician if irritation persists.

5
Box (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, New Jersey 07474

6
Packet Label

777-68

(Front)

Lysol ® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting Cleaning Wipes

ACTIVE INGREDIENT:

Alkyl (50% C14 40% C12 10% C12)

Dimethyl Benzyl Ammonimn Chlorides

INERT INGREDIENTS

TOTAL

0.28%

99.72%

100.00%

Keep Out OfReach

OfChildreu

CAUTION: See

Panel for additional

Precautionary

Statements

Does not include weight of dry wipe

(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

EPA Est. No. 52631-NJ-001

Net Contents: One Towelette

Reckitt & Colman

1655 Valley Road

Wayne, New Jersey 07474

7
UNITED 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 RecycledPaper
I 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) . Jtm-

'=

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)

ToiletsI 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'tchen, 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, forrt.::'~::.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>:ever ycu

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) =ZElOOlD!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<:'icle Aat, . 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 sOiledwith 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

=RSWlD

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 c1d e 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?LICAT ICNS 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-res icient i a l C;c

Use o,ly

/'( 'I '

.' / IN) Nct-Aopl teaet e 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 Valley Road

Wayne, NJ 07474

ATTENTION: Bruce Paolella

FEB 11 1GfiB

SUBJECT: Lysol®Brand Pre-Moistened Bathroom Touch-Ups Disinfecting

Cleaning Wipes

EPA Registration Number 777-68

Amendment forAlternate Formulations

YourAmendment Dated: November 22, 1999

EPA Received Date: November 24, 1999

This is to acknowledge receipt of your amendment to add alternate formulations forthis

product. TheConfidential Statements ofFonnula(CSFs) for the Alternate Formulations

(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 is unacceptable dueto the reasons listed below.

1) Three ofthe submitted formulations listReg: ~-.s a source ofactive ingredient. This

source contains four activeingredients which are not presen;~rrnulation. It appears that

this is a typographical error since oneformulation listsReg.~_~hich is anappropriate

. sourcefor yourproduct. Correct theReg. #'s associated withthis source.

'.

OFFICIAL.FI1.E COPY
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

_..

3) The certified limits are incorrect for th in formulations 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 all ofyour sources ofactive ingredients. Specifically,

Reg.~s not listed on this form. Submit an updated Formulator's Exemption which lists

all sources of active ingredients (in the Basic and Alternate Formulations) which you 'are currently

~ulate this product including the Reg.# of any 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

your intention to change the 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!IlTINGIIlDII!NI'INI'OIIMATION ISNO!'IN<J.UDED

Sincerely,

Velma Noble

Product Manager (31)

Regulatory Management Branch I

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 the jacket as a summarization of our 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 registrant to ~or;:ect this Reg. No.

2. One listed source.__ ~includes~san active

ingredient and is a product which is no longer marketedb~Alex says

I should tell the registrant that this product is 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, 001

CSF,

* * * 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 Cleaning Wipes

DP Barcode: D261607

Manufacturing-use [ ]

Reg. No. or File Symbol: 777-68

End-use Product [X]

Active Ingredient Composition:

Alkyl (50% C14, 40% Cl2, 10% C16)

dimethyl benzyl ammonium chlorides O.28%

TO:

FROM:

THRU:

THRU:

Velma Noble PM 31

Alex Traska, 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 amend the CSF to include four

Alternate Formulations which will be based on the use of different 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 November 22,1999, Certification Statement for

PR Notice 98-10, 656-130, 656-131, 656-132 and 656-133 Alternate Formulation

Confidential Statements ofFormula dated November 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.Upper and lower certified limits for both the active and inert ingredients are

acceptable.

5.All other elements 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 AT
November 22, 1999

Document Processing Desk (NOTIF)

Office of Pesticide 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 Statement per Pk-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 other changes have been made to the labeling or

the confidential statement of formula 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 that Ifthis notification is not consistent with the terms of

PR Notice 98-10 and 40 CFR 152.46, this product may 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

, " , ,

••••
November 22,1999

Document Processing Desk (AMEND)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room 266A, Crystal Mall 2

1921 Jefferson-Davis Highway

Arlington, Virginia 22202-4501

Attn: Velma Nobel

RE: Lysol Brand Sanitizing Wipes

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 )0 supply to EPA complete chemical composition of

the the agency should have chemical com osition

,information for 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 of Formula 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) 633-3633
FormApproved, OMS No.2070-0060, Approval expires

F nn 8570 1 (Rev.8 94) PrevIous ed tions are obsolete WhIte EPA File Copy (original. el c Appllcant Copy

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. NameandAddressof Applicant(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 Check ifthis is a new address

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 811 x5 '.4" (8J On label

o On labelingaccompanying product

6. Ma.nner in Which label is Affixed 10 Product o lithograph I2Sl other _Printed on package

o Paperglued

o Slenciled

Section-IV

1. conrect Point(Complete items directly below for identification of indiVidualto be 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 the etarements I havemadeon this form and anattachments niererc aretrue, accurate and complele. I Received

acknowledge Ihatany knowingly falseor misleading statemenl maybe punishable by fine 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

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

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

110I ce scr rccor 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 ce Ly .'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

nevi eve es Requested:

CH

EF

PL

CEB

I I

I I

I ,

i ,

,

I

I i

:-- , I

RES?:l<SE =$E

coot CAr::

\

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I

73

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IllSI mw. Respo~ II"I Respcnse

'CITCN Coo. 'JAN' 2.7

I mno b .3

-o ts« 'I.:;'

75-Ql..Y R£SfCl'/SE: COt: Dl.1"E: LJIY> Yo~ I I(N} No
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

Reckitt & Colman, Inc.

1655 Valley Road

Wayne, NJ 07474

JAN 17 IUUU

ATTENTION: Bruce Paolella

SUBJECT: Lysol® Brand Pre-Moistened Bathroom Touch-Ups Disinfecting

Cleaning Wipes

EPA Registration Number 777-68

Your Notification Dated: December 29,1999

EPA Received Date: December 30, 1999

Thisis to acknowledge receipt ofyour notification to add additional brand names forthe

above referenced product. This application is acceptable.

Theproposed alternate brand names "Lysol Brand Antibacterial Wipes," "Lysol Brand

Disinfecting Cleaning Wipes," and "LysolBrand Disinfecting Wipes" areacceptable and will be

made part oftherecord for this file.

Should you have any questions concerning this letter, please contact Tracy Lantz at

(703) 308-6415".

OFFICIAL. FILE COPY

Velma Noble

Product Manager (31)

Regulatory Management Branch T.

Antimicrobials Division (751OC)

ePA Form 1320-1A(1J90)

1,10C:TLaol>: 1/:;'1100:111 ~3 CONCURRENCES . . SYMBOL. "]/!;';;;" . ................- .................. ..................... .................... ..............,........ ..._.............. .....-..•......

SlJRNAME

i"I'aiffu"..................... ................. .................... .."................ ............... ...... ._...........- ..................... DATE . ..
)1

December 29, 1999

Document Processing Desk (NOTIF)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

Room 266A, Crystal Mall 2

1921 Jefferson-Davis Highway

Arlington, Virginia 22202-4501

Attn: Velma Noble PM-3l

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

Wipes

EPA Registration Number 777-68

Notification for alternate brand names

Dear Ms. Noble:

Reckitt & Colman Inc. would like to submit the following alternate brand names

for that above product registration:

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 8570R1, OPP Identification

Number 252964.

2) Certification statement as per PR- Notice 98-10.

Ifthere is any other information that is needed to complete this submission, please feel

free to contact me at 973-686-7391. I thank you for taking care ofthis notification.

~'uce lL~P~ 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) 633-3633
December 29, 1999

Document Processing Desk (NOTIF)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

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 per PR-Notice 98-10

This notification is consistent with the provisions ofPR Notice 98-10 and EPA

regulations at 40 CFR 152.46m and no other changes have been made to the labeling or

the confidential statement of formula 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 that Ifthis notification is not consistent with the terms of PR Notice 98-10

and 40 CFR 152.46, this product may be in violation of FIFRA and 1 may be subject to

enforcement action and penalties 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) 633-3633
Pleaseread inslructions on reverse before com}j,eling fonn.

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 of Applicant(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 Check if/his is a new a.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" X 8") (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 directly below foridentification ofindividual 10 be canlacted, ifnecessary, to process this application)

;;l73·J86-7391

Name TItle Telephonef'lf'. ("1r.lude Area

Bruce Paolella Senior Requlatory Affairs Specialist Code)

Certification

I certify that the slatemenls I havemade on this form and all attachmenIs theretoare true, accurate andcomplele. I

acknowledgethat any knowingly false or misleadingstatement may be punishableby fine or imprisonment or both

under appncable law.

6. Date Applicaton

Received

(Stamped)

3. Title

SeniorRegUlatory Affairs 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 Copy
Reviewer ID

Submission No.

Data Package No.

5«cf 'lcfI;.s--.,

B?:f)/ 73d 7f

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

125IProposed 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

lao I 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

1101 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

lXJE R.E:SPCt'lSE RESK:NSE

SEN! DATE REnJl<NED coee llA

"

\1 0 j'.}

I ,

EF

PL

NDEB

TB

DEB

Reviewers Requested:

CH

EEB

EFGB

/115 I FINAL Response f1

AcrICN code--J-L

7S-DAY RE~SE OOE J:ll\1E: L-!('l) Yes D(N) No
UNITED 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. Lee17aJ A

Product Man~ Antimicrobial Program Branch

Registration Division H7505C

Enclosure

,,

COHCURRI!HC!S

SYMBOl. ,

....•.......•...... .............•..-.................. .................. ....,............."............."..... ................... ................. SURNAME'

OATE )

.................. .....•........... ................. ..............,... ................. ....•....,.,.~" .... ...................-..................

EPAFonn 132Q..1A (1190) PrlIIIed qn RecycledPaper OFFiCiAL FILE COPY

·u.s. GOYOI'M'IllI'II PrintingOIfk:o; 10112 - G20-lJ.!i6(40072
New*

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 under7' '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

Walls,

Laun::lryFloors=

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 way to 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

L-__kill (hcusehold) gems

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 harrllesr meel d1airs, o:::wlte.rs t 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 =CAN: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

EPA Petition or EUP NO. ~~~ None ~--------

Date Division Recei'ved --"'=-"""="'- 12-13-91 -,-:. _

Type Product Hospital disinfectant/Impregnated Towellette

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

Product Manager ""''-''''''- PM-31 _

Product Name Lysol Brand Pre-Moistened Touch-Ups Disinfecting

Cleaning Wipes

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

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&F Products 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) Application for Pesticide Amendment, EPAForm. 8570-1, OPP Identifier No. 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 of review.

Your attention to this requested amendment is appreciated. If you have anyquestions, feel

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

Si/eIY, 7P

Paul

fa~~ J. ger/fit~V''16~. Manage, PA tory Compliaoce

RT:cjc

lencls

cc: Martha Delaoey

L&F Products

225 Summit Avenue, Montvale, New Jersey 07645-1575 (201) 573-5700
169925

Form Aoorovecf OMB No. 2070-0060.Acorcvatexmrestt·30·93

UnitedStatesEnvironmental Protection Agency BRegistration OPP ldenlifierNumber

Office 01Pesticide Programs (H7505C)

Washington, DC 20460 x Amendment

Application for Pesticide: Other .

Pleast! r,,"d Instructions on rev",.. b.fortt complDtlng 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 of AppflCant (Include ZIP Code)

L&F Products

225 Summit Avenue

Montvale, NJ 07645

o Check if this isa new address

6'. Expediled Review. In accordance with FiFAA Section 3(c)(3)

(b)(i), my product 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: Use additional 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 No. per Ojher (SpecifylL- 1

container

I

Waler SolublePackaging

By"

No

If ·Yes:

Package wgl.

No. per

Certrficatlon must be container

sub 'iH.A

Child-Resistant Packaging Unit Packaging

8y,,' 0 YesNo 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 LabelOn Labelinc accomcanvlnc product·

6. MannerIn Which Label Is AffixedTo Product § Uthograph

Paperglued

Stenciled

o Other( .~

Paul J. Kruger

Section IV

t. ContactPoint (Complere ftems directlY below for identification of individual to be contacted, if necessary,

Name Title Manager,

EPA Regulatory Compliance (201) 513-5329.

. y ~.

Certitlcatlon

I certify that the statements I have madeon this form and a11.;l!tachmenl$ theretoare true, accurateand c6mJ:.-I;;ta.

I acknowledge thatany knowingly Jalse or misleading statementmay be punishableby fine or imprisonmentor

both Undera~icablelaw. / /

3. Title

EPA

ManagE;r,

Regulatory Compliance

6. Date AppliCation

Received -.

: 19~ped,>

.." ; -q. . . .. . .,..,. t1 . • ',1.' .,~ , ", .'
TO:

NO NEW t.ABEt.

[

ATTACHED NOTIFICATION

1\

PM~ ';:0/ FROM: REG. SUPPORT BR. "y

~9

EPA REG. NO . """''1'''- I \ 109 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

Office of 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,on Restricneral 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 1No.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----- Paper glued

Stenciled

t. Contact Point (Complete items directly belowforidentiflcalion ofindividuaf to 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 Previous editions 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

L-__kill (hcusehold) ge:cns

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 ~edfor 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 HICROFICHING
Please 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 of letter

nfesubmission ,.... ' n~nal printed label

NOTIFICATION

Box Carton (only) back label .

Addition of phrase 'JNot Intended fo'rsPersonaL Hygiene!' -at-. 'end" .'

of DIRECTIONS FOR USE section.

Section III

t. MaterialThis Product Will Be Packa edln 2. Type of Gonla'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 .

Unit package wgt: INo. per container Package weight INo, per container f- Paper

Other (Spocify)

1. location of Net Contents Information 4. Size{s) of Retail Container

In 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 dfrecfly be/owforidentification of incffl/idllal to be

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

4. Typed Name qo

:rher (j 5. Date Signed

Paul J. February 8, 1991

EPA Form 8570-1 ( leN_ 4-88) Previous editions 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-
d· or bf r F Ap d NIB N 2070 0060 Ap 63090

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 ZIP Code)

L&F Products

225 Summit Avenue

Montvale. NJ 07645

In Check if 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 of letter

i n flesubmisslon

NOTIFICATION

Alternate name of:

R Lysol Brand Disinfectant Pine Action

.

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 INo. per container f-- Paper

Other (Specify)

t.tocaucn of Net Contents Information 4. SI20(S) of Retail Container

In 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 directly below for Identification of individual to be 0

Name --

Paul J. Kruger

Title Telephono No. (Inclucla Ama 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

225Summit Avenue, 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 r9,Jes{ I I
Lehn & 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 18 e. 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

-tenet seats -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:$" Duler conli;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_ $MI11lf _IIlJHOOO WIIIIlI:I tlUllllIa.1IltUlOIIIll1OUT 5Ql$. ""'._

_ 10 __ __" ..

~~-. I_..... CIUllOlt JlIQI/IDlMfIlMQUft1WNlllli1O*-_IICaUTIt-a .._ _ _ ..._ .... _ ....-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

TO: t&..t~

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 MICROFICHING
Please read In51r ctrcns on reverse before eompleting form Form Approved OMS No 2070-0060 Approval expires 6 30 90

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 Check if 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 Product Will 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 directly below for identification of individual to be

, ,",

Name

Ruth Trager

Title Technical Support Specialist Telephone No. (Include Area 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

Specialist I

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.

','

LAB8..I'''' L.. .",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

L-- kill _ (household) germs

A=vE INGREDIENr:

~l (50~_C14' 40% C1 2, 10% C1 6) 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)

/03
Travel 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

II\'!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 ." '

/01
Please 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. MaterialThis Product Will Be Packa

Child-Resistant Packaging

od 10

Unit Packaging

ny" hNO

If"YeS,"

Water-Soluble Packaging

ny" nNO

If"Yes,"

Unit package wgt INo. per container Package weight INo. per container

3. Location of Net Contents Information 4. Size(s) of RetailContainer

,nLabel nContainer

5. location of label Directions ran:~~~::~Ch label IsAffDd~~;r~:~:~)

On label r-- Paper glued

n,On material accompanying product Stenciled

Sectton IV

t. Contact Point (ComplBte items direcfly below foridenfificafion of individual tobe

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. Date Signed

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& Fink Products

225 Summit Avenue, 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

1101 Descriptor (Amend/Resubmi.asdons only)

15 I

1201 Registration Type,

17 (1) O::nditional

File SymOOl!Reg. No, ~l=l-bf

17 (R) Restricted

17 (G) General

180 I 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 ~;.­

in EPA k,

'JUN 2 8 1990

/1'1
Travel Size

BOX (POUCH) (CANISTER) LABEL

BACK

-3-

New*LYSOLR 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,r Datc4:

JUN 2 8 1990
Pink 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 for individual studies & to submit Pf'sticid6 BpfJlFcations. , ;;:

United States Environmental Protection ~ency Pack Number Date Rec6ivod cr: Office of Pesticide Programs .. Washington, DC 20460 ',',

SEPA Data Review Record :~!

Confi<jonthl Business InfortrlatJon - Do8s not amtaln

National&c1.JrityInformation (£.0. 12065) . .

1 "'t~~":!'!1;r<i/iI fJ-e -All{hi4<.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 tf/;-i7fO 9~/;>; Instructions

~}L r~(.JZ..u ~'<>-I dz 1:1Le

. Thfs Section Applies to ReviewofStudies Only

t4. O1eck Applicabl6 Box 15. No. of Individual Studies

i'Fl' Adverse 6(a}(2) Data {405} RGeneric 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 identify rho StvdY(HlS)) 0 No

". To Twe of Review t9. Reviews Also Sent to 20. Data Review Criteria

Science Analysis & Coordination f-- SAC DPC

A Policy Noto No. 31

Toxicology/HFA i- TOX/HFA Pl P .> HED Toxicology/IR _ TOX/IR 1 .. data which 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 particular concern EFED

Environme ntat 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

Economic Analysis 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 (EPA Form 8S7Q-4 Attached (Trado Secrets

liZ -
EFFICACY EVALUATION AND TECHNICAL MANAGEMENT SECTION

EFFICACY REVIEW - I

Antimicrobial program Branch

IN 02-15-90 OUT 05-02-90

Re v i ewe d By_-"''''-'''-''--''--'---'''-''-''-''''-''''-''--__--''-''-''c=..-''''-'==''-'' _

EPA Reg. No. or File Symbol -'-'--'-~-"- 777-68 _

EPA Petition or EUP NO, -"""'-''- None _

Date Division Received ~~~~~ 04-27-90 __

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 RPM I 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 10 2

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 au reus

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. au reus 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

EPA Reg. No. or File Symbol "-'-'---='_ 777-68 _

Da te Division Rece i ve d -'==-=-== 04-27-90 _

Data Accession No.(s) ~~~~~~_='_ 414597-01-03 _

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

4iXl' Proposed Crassntcanon r-1 Restric- X General I Ited

5. Name and Address of Applicant (Inc)ude ZiPCode)

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

Ovos DNo

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 directly below for identiffcafion of individual robe

cdif ,m esfhi,,,,,j,-,,ti,,,l

Name

John J. Domanski

Title

Director of Toxicolo~v

Telephone No. ('nc'ude Area 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 applicableaw..

Pebruarv 14

/2/ j<'\,~'~.'.. ' ,~,..- , , . 1990

Director of ToxicoloQ:v

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-eapondi nq 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 & Fink Products Group, Sterling Drug Inc.

225 Summit Avenue, Montvale.New Jersey 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 & Fink Products Group, Sterling Drug Inc.

225 Summit Avenue.Montvale, New Jersey07645! 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'vd ruci.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 jtaa t er- Label and

Packet Label.

Product IdAntity;

I,ysolR Brand Pr-e-Ho t 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.ca t.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.e s 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 ch r-ono Loc i.ca I order of receipt.

Al t.ucucb the 1988 E'IFRA amendments war-elate EPA to review

epp.Lt ca't.Lons for expedited z-eo ast ce.r.Lou or amendments :withiri 90

days) this t.ur nar-ou nd 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

mak Lno nece s s er-y pz-o cedu.raL changes in order to eliminate the

o a ckLc q 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-oce as Lno staff

Reqigtl:at~on Support Branch

gecr.iata-ec Lon nfvLs Lon (H7504C)
· -'., o

03/12/90

P'ro duc 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 p Ll ca t Ion No.: 124598 L( SPll Reg. No.: 777-68

SPA Receipt Date: 02/15/90 /

Subject: Front Sud Sc r e en for an Arnendmerrt

Your application for reg i s t r a t Lon has been received by the

Off Lee of Pest icide p r cc r eas and has passed a preliminary screen

for completeness. It will be p Laced in line fo r. ,review to

de t e r mLne its accep t.ab i 1 i t y , " The appl icat ion will be processed

in chron~logical order of receipt.

Although the 1988 FIPRA amendmene s-unand a t e EPA to review

eppLi ce t i on a .. for expedited r eq La t r a t i.cn or amendments within 90

days, th is turnaround time wi Ll, not b e me t; Inuned Lat e 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 chan qec in order to eliminate the

A- backlog lind to mee t the 90-day response ti.lJE: as soon as possible.

If you Lave any q ues t i onu you may cc n t ac t. John Len ,

Product Ma~~~er 31 at (703)-557-3675.

:Jllicerf:ly,

t: JJif>)L/fvJ'1

't'e cm Leader

Front End Processing Staff

R€Jt e t ro t Ion SUPj)ot't arencr,

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 1Action Cede J6/

[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 L110 16'1/ 1) I~I f1) DAY YR f1)!lAY YR

lao I 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

OFFICE OF PESTICIDES PROGRAMS 7Tl-6i3 n e- n An 1nnn

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'a nk s-r oduc cs Grcui,J

Division of aee r Li nq D:r:u<j

225 Summit avenue

ncnt.ve Le 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 Registere d/Reregiatered under

the Fe dera l 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 condi tii 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 a ti on j r-er eqist.ra t i 01.

of your product under FIFRA sec. 3(c)(5) when chc Aqeuc y 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 e re not c ompLi ed with, the rGoy isi.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 coosm tutes acceptance of these cond i t i ons ,

A s t amped copy of til" label is enclosed for your recul.·"~; •

¥,d-L/A.- deduct; naneqe r (31)

"AntimicrObial P'ro.j r am ucencn

1<eyist.raei on Di vis i on (H7505C)

LncLosure

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% CIn)

Dimethyl Benzyl Ammonlum Ch10rlaes

INERT INGREDIENTS:

0.28%

99.72%

Does not include weight of dry wipe.

KEEP OUT OF REACH OF CHILDREN

CAUT lON

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 07645
BOX 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% G14, 40% Gl 2, 10% Gl 6) .

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

LYSOL RBrand

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

cont ac 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 & Fink Products Group, Sterling Drug Inc.

225 Summit Avenue, Montvale, NewJersey 07645/201573-5700

August 9, 1989 PIlOGESS INFOllMATION IS NOT lNLLUuU)

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 //15 /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

140I Date Received by PM

10lceld-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 appttc ett on vate recelvea Oy F: Ivate rete rreo 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

Sout i ne type rent Chemical co t mission

Ovther /6/ fOl .

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 Algi ct de oPreserva- 0 San iti zergl tmtc tce ttve N.F.C.S. OOther

o New

Users

~EV:~i<~ Recctreo Iidentify oat a: 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.-orcjec teo re curn

C;.:RONOlOGICAl :-l!S'7lJRY OF EV£NTSI;IN cevst-otber ::ertir.ent tnsormetion CONTACTS
o

Disinfeccancs B'r anc h 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

Data Division Received -o__-c~~~~C_ 04/20/88 _

Impregnated Towelette/Hospital Disinfectant Type product --"'======-======'-=-'===-======-"

MRID No. (s) • =='-- None _ p r-odu c t Manage r -''-'''-'=-''---'-'==- PM 31 (Lee) _

Lysol Pre-Moistened Bathroom Touch-Ups

Disinfectant Cleaning Wipes

Produ ct 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 au reus

pseudomonas aeruginosa

10708

6538

15442

The submitted information completes and clarifies the data report.

/53
TECHNICAL SUPPORT SECTION EFFICACY REVIEW - II

Disinfectant Branch

EPA Reg. No. or File Symbol 777-AI7

Da t a Di visi on Rece i ved ---''"-'--''-''-L='- 04/20/88 _

MRID No ° t s ) 0 ==None _

Product Manager ---'-=--"-"---'-'='-'- PM 31 (Lee) _

. 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 & Fink Products Group, Sterling Drug Inc.

225 Summit Avenue, Montvale, New Jersey 07645/201573-5700

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:Iividually 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.

Distributed by Lehn & Fink Products Group, Division of Sterling Drug, Inc.,

Montvale, New Jersey 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.
LYSOLR

PRE-IDISTENED

I3MlffiOCM

mlCH-UPS

DISINFECI'ING Cl.El\NING WIPES

ACI'IVE INGREDIENT:

Alkyl (50~_C14' 40% C12, 10% Ct 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 Name of prccocc __"""""---'''-',,"'-'~'-'-'-1.'''-,",,-''~"'''- Brand Sanitizina Wiaes _

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

5/8/86 Signature

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 Se r-v l c as

Title Director Research Services

Date ...:..;"-'-'-'-- 5/8/86 __

-,.-. "':"'-
REV!sD 1-6-85 ~ef~r~nce 'fumoer _

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Page

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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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ACTION:

Res aonse

Cooe (<1 P26j;:~~cnse 1olsi crI(IJf71 ,~O DAY YR

,

- "., ..-
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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TECHNICAL StiFPORT SECTION CllEll!STRY REVE'. - i!

Disinfectants Branch

777 -.4I

JaC~ Division Received s- J3 8'6

z-cacc es xanage e 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

~3/8~ OUT 10/28/86

U/; 'L>J ,.':'" d.'/;1

5 E. Wilson, Jr. Date 10/27/86

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 ••.•......•.......•.••• 0.28
BACKGROUND

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

I N_-"-"'-=-"-' 02/09/87 _ OUT 02/11/87

02/09/87

S",;,...;" iL\ G-",.:<ll\

Reviewed BY_-"",-,,,,,,-,,,,,,---,=,,-,,-~,-- Sr:inivas Gowda Date_-=,,-,=c..=.-,-

EPA Reg. No. Ole File Symbol 777-AI

EPA Petition o r EUP NO. NONE

Data Division Received 05/13/87 --- Type produc t; Imp~egnated Towelette / Gene~al Disinfectant

Da te Accessi on No. ( e ) .-'2,,6,,2,,9,,9,,8"- _

Pr-oduct Manage~ PM 31 (Lee) ---'=-=---'-''-=-'-------------- P~oduct Name Lysol Brand Pre-Moistened Sanitizing Wipes

For-mula 86- 256A

Company Name Lehn & Fink Products Group, sterling Drug Inc.

S ubrn Lssion 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 chlorides
200.0

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-oduc t s Group, Sterling Drug rnc , ,

225 Summit Avenue, Montvale, New Jersey was submitted

to support efficacy of the subject product as bactericide/

mildewstat 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. Bac t e rLc Ld a 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. au reus 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. Expo s uz-e Time: Slides were wiped with one t owe Le t t.e

for 10 seconds and then liquid squeezed fz-om t owe Le 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'e s s ed Lfqu l. F:::':"O!l\

the wipe we ze 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. Expz-ea s e d liquid (0.1 ml)

from each t.owe Le t t;e were double subcultured in letheen broth.

6. Incubation of Bub cu Lt.u z-e s : 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 gu cv Lve L After Drying on a Hard Surface:

Test organism w/

5% Blood Serum

Staphylococcu~ au reus

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 10 7

Ave.No.Survivors

After Drying/Slide

9.6 x 10 6

1.3 x 10 7

1.7 x 10 6

Test

Organisms

S. au!:eus

S. choleraesuis

P. aeruginosa

Batch No. ce ezt e 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-es ence of 5% blood sex-cum,
b. Fungistat test (Mlhlewstat)

Fungistat activity confirmed by the test method EOL

evaluation of mildewstats on hard s uz-f ace s against

Asp~Lgillus nigeL ATCC NO. 6275. See attached " Pzocedur-e II

1. Conclusion: Resul ts show sa t La f act or-y pe z-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.c e .

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

l

TECHNICAL SUPPORT SECTION F.;l:"'fICACY REVIEW - II

Disinfectants BLanch

EPA Reg. No. or File Symbol ~~~~ 777-AI __

Date Division Received ~O=5_-~1~3~-~8~6"_ __

Data Accession No(s )__-'2,,6'-'2,,9'-9'-8"- ... 0-. ,

Produe t 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

sir t Ic acy 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-f ace s

in the presence of moderate amount of organic soil

(5% blood s e r-um) with a con t 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-e ae nce of mode r-a t 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'eme n t s z-e fe z- to DrS!TSS-3

e nc Lo s ur-e , item b.

203.0 Labeling

a e . Unde r' US8 Df rec t; lon s for disinfectant the d Lc-ect Ion s

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 Le t t.e ,

b. Unde r- n Ddre c t Lona fOL use" change II Mold And Mi Ldew

pr-eve n t.Lon II to read 'l Mold and Mildew Control II and

also change " To p reve nt; " to ze ad " To con t z-ol "

c. CovrpLe t e rt i eec t Ions for use must :)e lno jud ed t-o c Le an

and disinfect toilet surfaces.

·/0
UNITED 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 or dilution 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)
F 'A 'MB No 2000 0483 Approv"/IIXp;r.$ 9 30 87 oem t' •

&EPA ....... iACIRoAMII:NTltViiASTic¥loA.AGiN y ,

O ....ICII: 0 .. "II:STICIDIl "ROGRAM ',....7.71 PS_ rud ilWtlUdiona

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 pe s 7t~.1 x 101

,: .. ." 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 of lndlllldll4l to bl eonlfU:l.d, e. DATil: A ....LICATION RECItIVIlO

If neeeu<D')l, 10 pronu 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)Ltf~ 111. TITLIl

OJ r , Reseer'ch' ; '"' Services

•• TY"1l0 NAMIl '. )i ", ,1' ., , '., . I"~ OA,Iia

l;"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

EPA File Symtol/Reg. No. "7..:7..:7_- _ Date of encttcac ton _~":':":::'--- 5/3/86 __

Name of Product __LysolR Brand 'L"'-'---".!~!'\!"'-"-,,'!!.'.-'-'-£!"~-"-'-"''''- Sanitizing Wipes _

Lehn & Fink P.oducts Group

Di~islon of Sterling Drug, Inc.

Applicant' 5 Name and Address __-''---C--'-C--''''---C-:..::.:..::.=--'':..:::.::rC- _

225 Summit Avenue

nontve le , 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)

Date 5/8/86 Signature _

Title Director Research Services

Title Di.ector Research Services

Date --..:=::..=:"--- 5/8/36 __

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 act i.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.at ton or pacxaq i cq '

of another product whLch contains that active ingredient, '....his:h is r eqis ter-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 nforrmc i.on

reques ted on the cur-r-ent; CSF form No. 8570~4. The registered sour-ce ts ) 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

(cypedJ
DATA 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% C1qJ 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

Guide Li 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 Henufec turl 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'ec turlr 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 spec i fic orevt ty ---'
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 • Sanitizing Wipes 777- 4 , 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

63-8 Solubilitv n/a Eni Use Forn 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.abi l i tv x 5/8/86

63-14 ox idtz irct/reducino reaction n/a ,

63-15 Elemnabi 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/a
DATA RrWIREMENl' LISTING !'DR 1118 ruNER SUBMISSION ~1E'11I0D Of sUPfI);rr

1- Lyse I Brand Sanitizing Wipes 2. foPA REG.NO/fILE SYMBOL 3. !4.

PRODUCT N!'Jo1E: 777- FORMUUIDR'S E.:XEMPTI~' S"~'...ECTED Ir~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 AI kyl (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 REXlUI REMENTS 9. SOURCE OF DATA SATISFYING REXlUlREMENT MRID NUMBER.

Ba. ae, 9a. 9b. ge • . 9d. ge. 9f. EPA ACCESS!(X'J

Regulation Sutmitted Date Sulmi t ted Permisa i.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 lqul d 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 inhalat ion LC-50, rat - - - Pr-imary eye irritation, 5/8/86 Bl-4 rabbit x x - I81-5 PrImarv dearrne l 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 .

Fulllocplocp. 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 Drug Inc.

225 Summit Avenue,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

attachments
FILE 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, or Parts of Formula

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 of the

United States Department of Agriculture or other Federal agencies, or

to the courtsIn response to a subpoena, orto physicians, and In 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 acquired byauthority ofSection 4 ofthe "Federal Insecticide,

Fungicide, andRodenticide Act" ,

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'OIlWA11ON IS NOT INCLUOED

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 Tclera ace 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 if Fragrance 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 CAS Reg. ·Name: 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:dieDtKo. 1: _

TOL. STATUS: ~--_

OTHER INF.,

lo~ient No.3:

'pcc,

TOL. OTHERSTATUS: 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)

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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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,

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)

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the individual who prepared the response to your aeques t .
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

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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)

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by product registrants. If you have any questions, please contact

the individual who prepared the response to your 'reques t; .
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__-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)

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by product registrants. If you have any questions, please contact

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Identity of product inert ingredients.

Identity of product impurities.

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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.

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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)

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