6-0 6- i · 2011. 6. 6. · (- 0 6-0 6-[~) i (. united states environmental...

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. (- 0 6- 0 6- I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd. Northfield, Illinois 60093 Subject: Stepan Disinfectant Wipe JUN -6 2011 EPA Registration Number 1839-190 Notification Application Dated May 20, 2100 EPA Received Date May 23, 2011 Dear Mr. Isaac: This will knowledge receipt of your notification, submitted under the provisions of FIFRA section 3c 9. Based on a review of the submitted material the following comment apply. Pr:oposed Amendment: . Revised marketing statements for LitePak packaging (page1 of label) Addition of optional marketing claims (page 14 of label) Additional Warranty Statement (see page 14 of label) General Comments: Based on a review of the material sub,mitted, the following comment apply: The notification is acceptable. Acopy has been inserted in your file for future reference. Should you have any questions or comments concerning this letter, please contact Drusilla Copeland at (703) 308-6224. Product Manager (31) . D,..,.,.., 11..11 .......... ,,.., .... ,.., ,+.J;;t.... .h , . . .:- Nt I!S , .... .r- SYMBOL , ................................. _ ......... ... I:::_ .. .. : ... : .. I/ .................... _............. ............... . SURNAME' . DATE . i·················· ........ ........ ................. ................ ................. ................. . ..... _ ........ - EPA Form 1320-1A (1190) . - .... - Prillud 011 Recycled Paper OFFICIAL FILE COpy

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Page 1: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

. (- 0 6- 0 6- [~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY

Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd. Northfield, Illinois 60093

Subject: Stepan Disinfectant Wipe

JUN - 6 2011

EPA Registration Number 1839-190 Notification Application Dated May 20, 2100 EPA Received Date May 23, 2011

Dear Mr. Isaac:

This will knowledge receipt of your notification, submitted under the provisions of FIFRA section 3c 9. Based on a review of the submitted material the following comment apply.

Pr:oposed Amendment: .

• Revised marketing statements for LitePak packaging (page1 of label) • Addition of optional marketing claims (page 14 of label) • Additional Warranty Statement (see page 14 of label)

General Comments:

Based on a review of the material sub,mitted, the following comment apply:

The notification is acceptable. Acopy has been inserted in your file for future reference.

Should you have any questions or comments concerning this letter, please contact Drusilla Copeland at (703) 308-6224.

,cer~l7/ ve~~bble Product Manager (31)

. D,..,.,.., ,I~",n. 11..11 .......... ,,.., .... ,.., ,+.J;;t.... .h , .

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SYMBOL , ................................. _ ......... :~:::~~I ~:::~:.':.: ... I:::_ .. ~ .. : ... : .. I/ .................... _............. • ............... . SURNAME' . DATE . i·················· ........•........ ................. ................ ................. ................. . ..... _ ........ -

EPA Form 1320-1A (1190) . ~ -.... -

Prillud 011 Recycled Paper OFFICIAL FILE COpy

Page 2: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

-, - Form A'~~r'oV.d(.-- -. 'S No. 2070-0060 Print Form I ~ -r~~e~ •• ~e~~~.~d~l~n.~t~~~~o~n.~o~n~~~v~e~n~.~b!.~~~~!Jco~(~' __ .~.b~ina~~fo~nn~. __________________ -t~~'~~~~'~~~ __ ~Y~'~~~~2222~;;;;~~~==~~ __ .,

&EPA Unit!ld Stat8s

Environmental Protection Agency Washington, DC 20460 § Registration

Amendment x Other

Application for Pesticide - Section I

OPP Identifier Numb!lr

1. CompanvlProduct Number 1839-190

4. CompanvlProduct (Name) STEPAN Disinfectant Wipe

2. EPA Product Managar Velma Noble

PM' 31

3. Proposed Classification

o None D Restricted

5. Nam!l and Addre" of Applicant (Includs ZlP Cods) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) (b)(i). my product is similar or identical in composition and labeling to: Stepan Company

22 W. Frontage Rd. "'1_ ...... 1_£.:_1_1 II 'n"" .....

D Chsck if this is II nflw IIddrBSS

Am!lndm!lnt - Explain below.

D EPA Reg. No. ________________ _

Product Name

Section - II

Final printed labels in response to Agencv lener det!ld D

D o Resubmission In response to Agancv 18ner dat!ld ______ _

D D o

·Me Too· Applicetion.

Notification - Explain below. Other - Explein below.

Explanation: U"e additionel pege(s) if necessary. (For section I and Section II.)

1. Revised marketing statements for LitePak packaging (see page 1 of label). 2. Addition of optional marketing claims (see page 14 of label). 3. Additional Warranty Statement (see page 14 of label).

Section - III 1. Material Thi. Product Will Be Packaged In:

Child-Resistant Packaging

DVes·

Unit Packaging

0 V!I'

Water Soluble Packaging

D Ves

0 NO

• Certification must be submitted

DNo If ·Ves" Unit Packaging wgt. 1 oz.

3. Location of N8t Content. Informlltion

[8] label o Containar

~. Manner in Which lablll is Affind to Product

No. per container multiple

~ No

If ·Ves· Package wgt

4. Size(s) R8tail Container

35-150/canister

Paper glu!ld

I

No. per container

Othllr

2. Type of Container

~~:!~Ic Glass

X Paper Other (SpecifV) _______ _

5. location of lab81 Directions Dr"] On lab !II c:::J On lab81ing accompllnying product

[g Uthograph 0 Stenciled c eeL

~----------------------------==~~--~--~--~---------------------------."~------~ Section - IV L L ( (

~--------------------------------------------------------------------~,~ ... ~.------~ 1. Contact Point (Complste itsms directly bslow for idflntificstion of individuIII to be contsctsd. if nscesssry. to procsss this applicdrit?h.) ~

Name Title Tel!lphona No. (lncluJ!I Area C~dei ~ 'I ~ Thomas W. Isaac Sr. Regulatory Specialist (847)501-230~ (, L ( L

~-----------------------'-------------------....L---.,..--.c_--· __ :.. . , ~ I It t

Certification 6. Date"Appli(,ation l i I certify that the statements I have made on this form and all anachments thereto are tru!l. accurate and complete. ReCe~,<,6.:1L :: ( l : • '

I acknowl8dg!l that anv knowinglv false or misleading statament mav be punishablll bV fine or imprisonment or both und8r applicable law.

w,~ :4. Typed Name i

: Thomas W. Isaac

EPA Form 8570-1 (Rev. 8-94) ProVious oditions are obsolete.

J~ "l i\

(Sttmpedl ( l l ~

3. Title

Sr. Regulatory Specialist

5. Date

May 20, 2011

WhIt •• EPA file Copy (original) Yellow - Applicant Copy

Page 3: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

Stepan C' ~pan Company Northfield, 1l1i( 60093 Telephone B4, 446 7500

"This notification is consistent with the provisions of PR Notice 98-10 and

EP A regulations at 40 CFR 152.46, and no other changes have been made to the

labeling or the confidential statement of formula of this product. I understand that

it is a violation of 18 V.S.c. Sec. 1001 to willfully make any false statement to

EP A. I further understand that if this 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."

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Page 4: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

)\ Stepan I ?tepan Company ( .

\

May 20,2010

Document Processing Desk (NOTIF) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Antimicrobials Division

. Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501

ATTN: Ms. Velma Noble PM-31 Regulatory Management Branch I

RE: STEPAN® Disinfectant Wipe EPA Reg. No. 1839-190

Dear Ms. Noble:

This Notification proposes the following label additions:

Northfield, Illinois 60093 Telephone 8'--- "467500

~.

• Revised marketing statements for LitePak ™ packaging (page 1 of label). • Addition of optional marketing claims (page 14 of label). • Additional Warranty Statement (see page 14 of label).

LABELS: Five (5) draft labels are enclosed. One label is highlighted for Agency review.

s

Should the Agency need additional information in order to process this notification, please feel free to contact me immediately at (847) 501-2309 or via email: [email protected].

Sincerely, STEPAN COMPANY

-;-f~ w.~ Thomas W. Isaac Sr. Regulatory Specialist

Enclosures: Notification administrative package, labels (5 copies) TWI:slf

031-11~TI-EPA-1839-190

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Page 5: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

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STEPAN® DISINFECTANT WIPE (Optional statements:)

(CLEANER)(NEW)(QUICK)(EASY)(EFFECTIVE)(FAST EFFECTIVE) (CONVENIENT)

CLEANS, DISINFECTS & DEODORIZES ALL PURPOSE CLEANER ANTIBACTERIAL FORMULA CLEANS and DISINFECTS (ORANGE)(LEMON)(FRESH)(SOAP)(CITRUS)(SCENTED)(SCENT) (BLEACH-FREE)(ALCOHOL-FREE) *VIRUCIDALI/BACTERICIDALI/PSEUDOMONICIDAL Kills HIV-1 Kills Antibiotic Resistant Bacteria: CA-MRSA, MRSA, VISA and VRE Kills 99.9% of Bacteria in (just) 15 Seconds (!)** Kills Campylobaeter jejuni in (just) (1 minute) (60 seconds)(!{ Disinfects (household), (kitchen) and/or (bathroom) bacteria Kills Flu Virus tt Kills Pandemic 2009 H1 N1 Influenza A virus (formerly called swine flu) LitePak ™ (can)(canister), uses (X)% less (material) (plastic) than (previously used can) (other)(most) cans of

this size! LitePak ™ (can) (cans) (canister) (container) = (equals) less packaging (than most cantainers of this size) (than

most cans of this size)!

** Staphylococcus aureus (Staph), Klebsiella pneumoniae, Listeria monocytogenes, Escherichia coli (E. coli) 0157:H7

tPseudomonas aeruginosa, Staphylococcus aureus (Staph), Salmonella enterica (Salmonella), Streptococcus pyogenes (Strep), Escherichia coli (E. coli) 0157:H7

tt Influenza A2/Japan

ACTIVE INGREDIENTS Alkyl (60% C14, 30% C16, 5% C12, 5% C1S)

dimethyl benzyl ammonium chlorides ........ ~ ............ . Alkyl (68% C12. 32% C14) dimethyl ethyl benzyl ammonium chlorides ............................ . INERT INGREDIENTS ............................................ .

Total

0.14%

0.14% 99.72%

100.00%

KEEP OUT OF REACH OF CHILDREN

CAUTION See side (back) panels for additional precautionary statements.

EPA REG. NO. 1839-190 EPA EST. NO. 1839-IL-01

STEPAN COMPANY 22 W. Frontage Rd. Northfield, IL 60093

NET CONTENTS: X Ibs. X OlS. (minimum wt. X Ibs. X OlS.)

(mandatory: must be expressed in avoirdupois pounds and ounces)

Optional: can also express as total count and size X (Pre-measured) (Pre-moistened) (Wipes) (Towelettes) (Cloths) (X)" x (X)"

(e.g. 40 Pre-measured Wipes (7" x 8') (18cm x 20cm)

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(e.g. 40 Pre-measured Single Use Towelettes (7" x 8') (18cm x 20cm)

(page 1 of 14) Notif 04112/11

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Page 6: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

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(optional additional bullet points for label)

• (Antibacterial) (Disinfecting) and scrubbing power all in one • 99.9% effective in 15 seconds against Staphylococcus aureus (Staph) (ATCC 6538), Klebsiella

pneumoniae (ATCC 4352), Listeria monocytogenes (ATCC 35152), Escherichia coli (E. coli) 0157:H7 (ATCC 43895).

• Effective in (1 minute) (60 seconds) against Campylobacter jejuni (ATCC 29428) • 99.9% effective in killing common (household) (kitchen) (bathroom) bacteria • (Alcohol) (Solvent) (Bleach) free • Antibacterial formula cleans and (disinfects) (sanitizes) in one step • (Antimicrobial) (Antibacterial) wipes • (Clean) and (Sanitize) and (Disinfect) non-porous surfaces (in any room in the house) (throughout

the house) • (Clean) and (Sanitize) and (Disinfect) any room in the house • Cleaning made easy for all your hard, non-porous surfaces • Cleans and cuts grease • Cleans tough stains • Cleans with (just) one wipe • Cleans with no need for sprays or buckets • Cleans without scratching your surfaces • Cleans, (sanitizes) (disinfects) and deodorizes • Convenient flip top lid • Convenient wipes • Cuts through tough grime • Disposable cloth wipes • Easy Cleaning (Around the house) • Easy convenient dispensing • Easy to use • Easy to use package (canister) to keep your wipes moist • Effective against odor-causing bacteria • Effective daily use • Effective in (sanitizing) (disinfecting) your (kitchen) (bathroom) surfaces • Eliminates odors • Fast and easy way to clean • Fast and effective cleaning • For all non-porous household surfaces • For all your (heavy) (light) duty jobs • (Hospital) (General) disinfectant wipes • Great for on-the-go cleaning • Hard surface (disinfecting) (sanitizing) wipe • Ideal for cleaning and (sanitizing) (disinfecting) any non-porous surface • Just pull, wipe and toss • Kills 99.9% of Staphylococcus aureus (Staph) (ATCC 6538), Klebsiella pneumoniae (ATCC

4352), Listeria monocytogenes (ATCC 35152), Escherichia coli (E. coli) 0157:H7 (AT90 (1<3~95) in (just) 15 seconds(!) t, L t

• Kills 99.9% of Escherichia coli (E. coli) 0157:H7 (ATCC 43895) in (just) 15 seconds(!) (~ , ~ • Kills Campy/obacter jejuni (ATCC 29428) in (just) (1 minute) (60 seconds)l l' ,

• Kills common (household) (kitchen) (bathroom) bacteria • (Kitchen) and (Bathroom) wipes • Leaves a clean, fresh scent • Leaves your (bathroom) (kitchen) fresh and clean • Lint-free • Made with scrubbing fibers • Multi-purpose (sanitizing) (disinfecting) wipe

Stepan Company Norlhfield, IL 60093 EPA Reg. No. 1839-190 (page 2 of 14)

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Page 7: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

• • • • • • • • •

• • • • • • • • • •

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Non-scratching wipe Non-woven disposable (wipes) (cloths) (towelettes) Nursery room (wipes) (cloths) (towelettes) One-step cleaning Pre-moistened (wipe) (towel) (towelette) (cloth) Quick and easy clean-ups Quick cleaning Ready to use (R-T-U) wipes

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(Sanitize) (Disinfect) your household surfaces: highchairs, booster seats, strollers, car seats, cribs, tabletops, countertops, appliance exteriors, sinks, and glazed tiles (Sanitizing) and/or (Disinfecting) wipe Saves time (Solvent) (Alcohol) (Bleach) free (sanitizing) (disinfecting) (wipes) (towelettes) (cloths) Strong wipe for tough jobs Textured (cleaning) (wipe) (towelette) (cloth) for better cleaning Textured (wipe) (towelette) (cloth) surface for better cleaning The smart way to clean and (sanitize) and/or (disinfect) Touch-up cleaning any time Use every day in every room (throughout the house) Use in (public toilets) (Laundromats) (camp sites) (pet areas) (hotels) (motels) (lodging establishments) (manufacturing facilities) (factories) (offices) (office buildings) wherever (sanitizing) (disinfecting) is important Use on hard, non-porous surfaces: (stainless steel) (Formica®) (glass) (glass tables) (glazed porcelain) (plastic) . Use on (equipment) hard, non-porous surfaces

(This product or product name) is bactericidal in the presence of organic soil (5% blood serum) against Escherichia coli (E. coli) 0157:H7 (ATCC 43895), Salmonella enterica (ATCC 10708), Pseudomonas aeruginosa (ATCC 15442), Staphylococcus aureus (Staph) (ATCC 6538), Streptococcus pyogenes (Strep) (ATCC 19615), Community Associated Methicillin resistant Staphylococcus aureus Genotypes 300 and 400 (CA-MRSA), Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecium (VRE) and Vancomycin intermediate resistant Staphylococcus aureus (VISA) at 5 minutes contact time.

(This product or product name) are (is a) non-woven, disposable (towelette(s» (wipe(s», pre-saturated with a quaternary disinfectant cleaner.

(This product or product name) is intended for use in: • hospitals and healthcare settings: ambulances, anesthesia, CAT labs, CCU, Central Supply, Clinics,

Dental Offices, Dialysis Clinics, Doctor's office(s), Emergency Rooms, E.R., Home health care, Hospices, ICU, Laboratory, Laundry rooms, Neonatal Intensive Care Units (NICU), Newborn nursery, Nursing homes, Operating rooms, Pediatrics, Pediatric Intensive Care Units (PICU), Physical therapy, Physician's office(s), Opthalmic offices, Radiology, Recovery Room, Rehabilitation, Respiratory therapy, Surgery, Transport vehicles, X-Ray

(and/or) , 'c (: C ,

• Critical Care Areas: CCU, Emergency Rooms, E.R., I.C.U. Neonatal Intensive Care Units «i\lICU), Operating Rooms, Pediatric Intensive care Units (PICU), Surgery, Opthalmic offices L ~ ( ~

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• Veterinary clinics, animal hospitals, animal life science laboratories, kennels, pet animal kennels, breeding establishments, grooming establishments, pet animal quarters, zoos, pet shops, tat::.1< sl;>ops

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• Animal holding areas, veterinary waiting rooms, veterinary examination rooms, veterir,art 'X-ray rooms, veterinary operating rooms, animal transportation vehicles

• Beauty salons, barber shops, correctional facilities, funeral homes, mortuaries

• Schools, health clubs, gyms, athletic facilities, airports, transportation terminals • Grocery stores, Shopping Centers, Delicatessens, Catering facilities, Banquet halls

• Nursery, Daycare centers

Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 3 of 14)

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Page 8: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

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• Households, homes, residences

• Household kitchens and/or bathrooms

• Institutional kitchens and/or bathrooms (This product or product name) will clean and disinfect hard, non-porous, surfaces of: bed railings, cabinets, carts, chairs, counters, exam tables, gurneys, isolettes, IV poles, stethoscopes, stretchers, tables, telephones, toilet seats, toilets, bathtubs, bathroom fixtures, shower stalls, sinks, tiles, vanity tops, hospital beds, traction devices, MRI, CAT, scales, paddles, wheelchairs, ultrasound transducers and probes.

(This product or product name) will clean and disinfect hard, non-porous surfaces of: grocery cart handles, grocery carts, shopping carts, grocery cart child seats.

(This product or product name) will clean and disinfect hard, non-porous surfaces of: changing tables, cribs, diaper pails, trashcans, garbage cans.

(This product or product name) will clean and disinfect hard, non-porous surfaces of: cabinets, chairs, computers, countertops, desks, desktops, doorknobs, fax machines, garbage cans, headsets, keyboards, railings, seats, sinks, tables, tabletops, telephones, trashcans, appliance exteriors, (bathroom)(kitchen) faucets, bathtubs, shower (doors)(stalls), stove tops.

(This product or product name) will clean and disinfect hard, non-porous surfaces of: gym equipment, exercise machines, wrestling mats, gymnastic equipment.

Use (this product or product name) to clean and disinfect non-porous personal protective safety equipment, protective headgear, hard hats, half mask respirators, full face breathing apparatus, gas masks, goggles, spectacles, face shields, silicone rubber or PVC hearing protectors and vinyl covered ear muffs. Rinse all equipment that comes in prolonged contact with skin before reuse with clean warm water (about 120°F), and allow to air dry. (Caution: Cleaning at the 120°F temperature will avoid overheating and distortion of the personal safety equipment that would necessitate replacement.)

(This product or product name) is formulated to disinfect hard, non-porous, inanimate environmental surfaces such as floors, walls, metal surfaces, stainless steel surfaces, glazed porcelain, glazed ceramic tile, plastiC surfaces, bathrooms, shower stalls, bathtubs, and cabinets.

(This product or product name) cleans and/or disinfects and/or deodorizes.

Antibacterial (wipes) (formula)

Disinfects in (just) 5 minutes.

Kills 99.9% of bacteria in (just) 15 seconds.

Kills 99.9% of bacteria** that can cause food borne illness on hard, non-porous surfaces in (just) (1 minute) (60 seconds).

Kills 99.9% of Campylobacter jejuni (ATCC 29428) in (just) (1 minute) (60 seconds)

Kills Influenza A2/Japan the virus that causes the flu.

Leaves hard, non-porous surfaces disinfected.

One step (cleaning) and lor (disinfecting) and/or (deodorizing). l

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Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 4 of 14)

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Page 9: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

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DIRECTIONS FOR USE It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

(For labels that list medical premises and metal and/or stainless steel surfaces, one of the following statements must be used:) This product is not to be used as a terminal sterilantlhigh-Ievel 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 of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. or This product is not for use on critical and semi-critical medical device surfaces.

CLEANING: Use one (product name) (wipe) (towelette) to completely remove all (gross) (major) (loose) (dirt) (and) (debris) from surfaces to be treated.

DISINFECTING: To disinfect hard, non-porous surfaces, thoroughly wet the surface to be treated. Treated surface must remain visibly wet for disinfecting. Use enough (wipes) (cloths) (towelettes) for treated surface to remain visibly wet for 5 minutes. For heavily soiled surfaces, clean before following disinfecting instructions. Allow surfaces to air dry.

(This product or product name) is an effective disinfectant against Escherichia coli (E. coli) 0157:H7 (ATCC 43895), Pseudomonas aeruginosa (ATCC 15442), Salmonella enterica (Salmonella) (ATCC 10708), Staphylococcus aureus (ATCC 6538), Streptococcus pyogenes (Strep) (ATCC 19615), Vancomycin resistant Enterococcus faecium (VRE) (ATCC 51559), Methicillin resistant Staphylococcus aureus (MRSA) (ATCC 33591), Community Associated Methicillin resistant Staphylococcus aureus (CA­MRSA) Genotype USA400, Community Associated Methicillin resistant Staphylococcus aureus (CA­MRSA) Genotype USA300 and Vancomycin intermediate resistant Staphylococcus aureus (VISA) (ATCC 700699).

*VIRUCIDAL ACTIVITY: (This product or product name) is an effective virucide on hard, non-porous surfaces against Influenza A2/Japan, Herpes Simplex Virus 1 (ATCC VR-260), Human Immunodeficiency Virus, Type 1 (HIV-1) and Herpes Simplex Virus 2 (ATCC VR-734) when the treated surface is allowed to remain wet for 5 minutes. Allow surfaces to air dry.

a tional statements to a ear an where on the label

• Respiratory illnesses attributable to Pandemic 2009 H1 N1 are caused by Influenza A virus. This product (Product Name) is a broad-spectrum hard surface disinfectant that" has been shown to be effective against (Influenza A virus tested and listed on the label) and is expected to inactivate all Influenza A viruses including Pandemic 2009 H1 N1 (formerly called swine flu).

• This product (Product Name) has demonstrated effectiveness against Influenza A virus and is expected to inactivate all Influenza A viruses including Pandemic 2009 H1 N1 Influenza A virus.

• This product (Product Name) has demonstrated effectiveness against (Influenza A virus tested and listed on the label) and is expected to inactivate all Influenza A viruses including Pandemic 2009 H1 N1 (formerly called swine flu).

• Kills Pandemic 2009 H1 N1 Influenza A virus (formerly called swine flu). • Kills Pandemic 2009 H1 N1 Influenza A virus. L-___ ~ ________________________________ ";-[_C-l

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c ( ( c KILLS HIV-1 ON PRE-CLEANED ENVIRONMENTAL SURFACES/OBJECTS PREVIOUSLY SOILED WITH BLOOD/BODY FLUIDS in health care settings (Hospitals, Nursing Homes) or other settings in which t:~er~ Li~ an expected likelihood of soiling of inanimate surfaces/objects with blood or body fluids, and in ~hLi~h' the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for tran~rriss~on of Human Immunodeficiency Virus Type 1. ~ ell (

SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION AGAINST HI\:'-1 (OF ( L L

SURFACES/OBJECTS SOILED WITH BLOOD/BODY FLUIDS. l l l l

PERSONAL PROTECTION: When handling items soiled with blood or body fluids, use disposable latex §iloves, gowns, masks and eye coverings. t (

CLEANING PROCEDURES: Blood and other body fluids must be thoroughly cleaned from surfaces a,'d'OlJjects before application of (this product or product name). l

CONTACT TIME: Allow surface to remain ~et for 5 minutes. ~ t l l l l

DISPOSAL OF INFECTIOUS MATERIALS: Blood and other body fluids should be autoclaved and disposed of according to local regulations for infectious waste disposal.

Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 5 of 14) Notif 05/19/11

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/J ( ( -FUNGICIDAL ACTIVITY: (This product or product name) is an effective fungicide against Trichophyton mentagrophytes (ATCC 9533) (causative agent of Athlete's Foot Fungus) (a cause of ringworm) (a cause of ringworm of the foot), when used as directed on hard surfaces found in bathrooms, shower stalls, locker rooms, exercise facilities or other clean, hard, non-porous, surfaces commonly contacted by bare feet. The surface must remain visibly wet for 3 minutes. Allow surfaces to air dry.

EFFICACY TESTS HAVE DEMONSTRATED THAT (THIS PRODUCT OR PRODUCT NAME) IS AN EFFECTIVE BACTERICIDE, VIRUCIDE AND FUNGICIDE IN THE PRESENCE OF ORGANIC SOIL (5% BLOOD SERUM).

For Ultrasound Transducers and Probes:

Use only on external surfaces of ultrasound transducers and probes.

With a clean washcloth, clean gel from external surface of the ultrasound transducer or probe to be disinfected. Then thoroughly wet probe with (wipe(s) (towelette(s)). Treated surface must remain wet for 5 minutes. Use additional (wipe(s)) (towelette(s)) if needed to assure continuous 5 minute wet contact time. Let air dry.

SANITIZING/DEODORIZING: To sanitize/deodorize hard, non-porous surfaces; wipe surface, using enough (wipes) (towelettes) (cloths) to allow treated surface to remain wet for 15 seconds for Staphylococcus aureus (Staph) (ATCC 6538), Klebsiella pneumoniae (ATCC 4352), Listeria monocytogenes (ATCC 35152), Escherichia coli (E. coli) 0157:H7 (ATCC 43895) (and) (1 minute) (60 seconds) for Campylobacter jejuni (ATCC 29428). Let surface dry. For highly soiled surfaces, clean excess dirt first.

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

For plastic and painted surfaces, spot test on an inconspicuous area before use.

(This product or product name) will not harm most surfaces: including acrylic, fiberglass and vinyl.

Do not use on unpainted wood.

Not for personal cleansing. This is not a baby wipe! Do not flush in toilet.

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Canister Directions (Use any of the following instructions - can also use with canister icon)

TO OPEN: • Remove lid from canister. • Lift flap in center of lid. • Pull up corner of center (wipe) (towelette) (cloth), twist to a point and thread through dispenser hole in

lid. DO NOT PUSH FINGER THROUGH OPENING. • Replace lid. Pullout exposed (wipe) (towelette) (cloth) and snap off. The next (wipe) (towelette) (cloth)

pops up automatically. Dispose of used (wipes) (towelettes) (cloths) in trash receptacle. Snap center flap down when finished to retain moisture.

• Do not flush.

TO OPEN PACKAGE: Flip open dispensing cap and remove lid by pulling upward. Thread center (wipe) (towelette) (cloth) corner through slits in lid center. DO NOT PUSH FINGER THROUGH OPENING. Replace lid. Dispense (wipes) (towelettes) (cloths) by pulling out at an angle. Snap flip lid down when finished, to retain moisture. Dispose of used (wipes) (towelettes) (cloths) in trash. Do not flush.

TO OPEN PACKAGE: Pop open dispensing tab and remove top by lifting upward. Pull up corner of center (wipe) (towelette) (cloth), twist to a point and thread through slits in top. DO NOT PUSH FINGER THROUGH SLITS. Replace top and pull (wipe) (towelette) (cloth) at slight angle. The next (wipe) (towelette) (cloth) pops up automatically. Snap tab closed to retain moisture. Do not flush.

DISPENSER: To start feed, remove (large) cover and discard seal from container. From center of (wipe) (towelette) (cloth) roll, pull up (wipe) (towelette) (cloth) corner, twist into a point and thread it through the hole in the container cover. DO NOT PUSH FINGER THROUGH HOLE. Pull through about one inch. Replace cover. Pull out first (wipe) (towelette) (cloth) and snap off at a 90 degree angle. Remaining (wipes) (towelettes) (cloths) feed automatically ready for next use. When through using, keep small center cap closed to prevent moisture loss. Do not flush.

Flip-top Canister Directions (can also use with Flip-top Canister icon) TO OPEN PACKAGE: 1. Lift tab at front of lid to open. 2. Pull up corner of center sheet and thread through dispenser slit in lid. 3. Pull out exposed (wipe) (towelette) (cloth) at a 45 degree angle and snap off. The next (wipe) (towelette) (cloth) is ready for dispensing. 4. Close lid to retain moisture. 5. Dispose of used (wipes) (towelettes) (cloths) in trash (receptacle). Do not flush.

Flip-top Canister Directions (can also use with Flip-top Canister icon)

TO OPEN PACKAGE: Lift tab at front of lid to open. 1. Pull up corner of center sheet and thread through dispenser slit in lid. 2. Pull out exposed (wipe) (towelette) (cloth) at a 45 degree angle and snap off. The next (wipe) (towelette) (cloth) is ready for dispensing. 3. Close lid to retain moisture. 4. Dispose of used (wipes) (towelettes) (cloths) in trash (receptacle).Do not flush.

Refillable Package Instructions: (Use with product supplied in refillable packages)

TO OPEN PACKAGE: Flip open dispensing flap and remove lid by lifting upward. Place (pouch) (package) in (container) (tub). Open pouch by peeling back seal. Insert (wipe) (towelette) (clotr> ,~I<:K)c~gh opening in lid. Replace lid. The next (wipe) (towelette) (cloth) pops up automatically. When finisho(h close lid flap to retain moisture. " ~':

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Refill Package Instructions: (Use for refill paCkage)

TO OPEN PACKAGE: Flip open dispensing flap and remove lid by lifting upward. Place refill in f'::Qnt~iner) (tub). Open (container) (tub) by peeling back seal. Insert (wipe) (towelette) (cloth) through opel~linCg. i~-lid. Replace lid. The next (wipe) (towelette) (cloth) pops up automatically. When finished, close lid"toJEitain moisture. (l (l

Resealable Package Instructions: (Use for product supplied in resealable pouches/packages) : ( ( , ( ,

TO OPEN PACKAGE: Slowly peel back label. (Pullout) (Remove) (wipes) (towelettes) (cloths) as needed. To retain moisture, reseal (pouch) (package) by firmly pressing label back on th~G "J:i~l:ich) (package).

Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 7 of 14) Notif 05/19/11

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Single Use Pouch Instructions: (Use for product supplied in single use pouches/packets)

TO OPEN PACKAGE: Tear pouch open (along dotted line) (at tear notch) (along the top edge of pouch). (Pull out) (Remove) (wipes) (towelettes) (cloth).

For product supplied in a single use pouch with a folded towelette, include the following)

Unfold (wipe) (towelette) (cloth) before use.

Center Pull Dispenser Instructions: (Use for product supplied in plastic bags)

TO OPEN PACKAGE: (Open lid of the dispenser.) (Cut "V" out of the top of the (plastic) bag.) (Tear open (tab on) top of (plastic) bag.) (Cut open top of (plastic) bag.) (Remove the Styrofoam core from the center of the roll.) Pull out the first (wipe) (towelette) (cloth) approximately 6 to 8 inches from the center of the roll. (Place entire bag inside of center pull dispenser. Thread the (wipe) (towelette) (cloth) through the opening on the dispenser.) Place entire bag inside of center pull dispenser). Close the lid of the dispenser.) «Wipe) (Towelette) (Cloth) dispensing tension may be adjusted on the bottom of the dispenser). (Additional loading directions are listed on the dispenser.) Dispenser may be mounted with (wipes) (towelettes) (cloths) (dispensing up) (dispensing down) (dispensing up or down).

PRECAUTIONARY STATEMENTS Hazards to Humans and Domestic Animals

CAUTION: Causes moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after handling.

FIRST AID Have the product container or label with you when calling a poison control center or doctor, or going for treatment.

IF IN EYES: Hold eyes open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses if present, after the first 5 minutes, then continue rinsing. Call a poison control center or doctor for treatment advice.

(Optional) You may contact XXXlXXX-XXXX for emergency medical treatment information.

STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage or disposal.

(The following Storage/Disposal statement can be used for household and Institutional/Industrial products)

(Optional for product supplied in nonrefillable canisters)

CONTAINER STORAGE/DISPOSAL: Store in an area inaccessible to children. Wipes: Dispose of (wipe) (towelette) in trash after use. Do not flush. Canister: Tightly close lid between uses to retain moisture. Nonrefillable container. Do not reuse or refill this (container) (canister). Offer empty (container) (canister) for recycling if available or discard in trash. C l II

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CONTAINER STORAGE/DISPOSAL: Store in an area inaccessible to children. Wipes: Dispose(0f"(~>ipe) (towelette) in trash after use. Do not flush. Container: Refill only with (this product) (product name). Do not reuse or refill except as described in the directions for use. Tightly close lid between use~ 'tD i~tain moisture. Offer empty (container) (tub) for recycling if available or discard in trash. Refill ~Pa{;kage) (Container) (Pouch): Nonrefillable (package) (container) (pouch). Do not reuse or refill this (~paGkage) (container) (pouch). Offer empty (container) (package) (pouch) for recycling if available or discard'i'n M'lsh.

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CONTAINER STORAGE/DISPOSAL: Store in an area inaccessible to children. Wipes: Dispose of (wipe) (towelette) in trash after use. Do not flush. Resealable (Package) (Pouch): Reseal label betweon<u££s to retain moisture. Do not reuse or refill empty (pouch) (package). Offer empty (package) (pouch) for recycling if available or discard in trash.

(Optional for Product Supplied in Single Use PoucheS/Packets)

Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 8 of 14) Notif 05/19/11

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c· ( ( ) -CONTAINER STORAGE/DISPOSAL: Store in an area inaccessible to children. Wipes: Dispose of (wipe) (towelette) in trash after use. Do not flush. (Pouch) or (Packet): Offer empty (pouch) (packet) for recycling if available or discard in trash.

(Optional for Product Supplied in plastic bags for use in Center Pull Dispensers)

CONTAINER STORAGE/DISPOSAL: Store in an area inaccessible to children. Wipes: Dispose of (wipe) (towelette) (cloth) in trash after use. Do not flush. Dispenser: Refill only with (this product) (product name). Do not reuse or refill except as described in the directions for use. Keep dispenser closed to retain moisture. Plastic Bag: Do not reuse or refill empty plastic bag. Offer empty plastic bag for recycling if available or discard in trash.

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Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 9 of 14)

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Bathtub

Door Knob

Tub and Shower walls

Toilet

Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190

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Canister Directions Changing Table

Garbage Can

Baby's Room

(page 10 of 14)

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Computer

Flip Top Canister

Shopping Cart

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Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190

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(page 11 of 14)

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Pouch/Packet Label to be used with Master Container Label

STEPAN® DISINFECTANT WIPE

EPA REG. NO. 1839-190 EPA EST. NO. 1839-IL-01

Net Contents: X Ibs. X ozs. (mandatory: must be expressed in avoirdupois pounds and ounces)

o tional: can also ex ress as total count and size 1 (Wipe) (Towelette) (Cloth)

ACTIVE INGREDIENTS Alkyl (60% C14 , 30% C16, 5% C12, 5% C18)

dimethyl benzyl ammonium chlorides .................... .. Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chlorides .......... , ................. . INERT INGREDIENTS ........................................... ..

Total

0.14%

0.14% 99.72%

100.00%

KEEP OUT OF REACH OF CHILDREN

CAUTION SEE (OUTER CONTAINER) (BOX) FOR PRECAUTIONARY STATEMENTS AND USE DIRECTIONS.

DISPOSAL: DISPOSE (WIPE) (TOWELETTE) (CLOTH) IN TRASH AFTER USE. DO NOT FLUSH. OFFER EMPTY (POUCH) (PACKET) FOR RECYCLING IF AVAILABLE OR DISCARD EMPTY IN TRASH.

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(NOTE TO REVIEWER: The following statements are optional and may appear anywhere on the label)

Warranty Statements

Satisfaction guaranteed

Money back if not 100% satisfied.

Unconditional Guarantee If for any reason you are not completely satisfied with your purchase, simply return the product with proof of purchase for a replacement or refund, whichever you prefer. We welcome any comments or questions you may have. When writing, please include the 12-digit UPC number. Questions? [phone number]

[Product or brand name] Satisfaction Plus! [product or brand icon] If you are not satisfied with any [customer brand] product, simply return it to the store where purchased. We will refund your money PLUS replace the item with a like item of the brand of your choice-FREE.

[customer brand] Guarantee Complete Satisfaction Or Your Money Back

Satisfaction Guaranteed For information call [phone number] [website address]

Quality Assured [product or brand icon] Satisfaction guaranteed or your money back

Quality Assured I am proud to put my name on this product. Think of it as your guarantee that we've done our best to bring you the best. [name/ signature] (to be used with Meijer brand only)

[customer brand] Quality [icon] Money back guarantee

[customer brand] Quality Guaranteed [icon]

[customer brand] Your Satisfaction is Guaranteed [icon]

Our promise. Offering premium quality products at an exceptional value is our ongoing commitment to you. Our goal is to ensure that this and every [customer name] product meets or exceeds your expectations for quality and performance. Your satisfaction is guaranteed every time you use this product. For questions or comments regarding this product, visit [website address] or call toll free in the continental U.S. [phone number], [time], [time zone], [days of the week]. (to be used for Mambers

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[customer symbol] Quality Guaranteed: 100% Satisfaction Guaranteed with [all] [this] [custo'rr,&~ ~. brand] Product[s] [or Your Money Back], [return it for a refund or replacement]

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Cleans, Disinfects. Guaranteed. Return the unused portion with receipt for a replacement or~yMr' \ money back.

Comments or questions? [phone number] [website]

Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 13 of 14) Nolif 05/19/11

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Page 18: 6-0 6- I · 2011. 6. 6. · (- 0 6-0 6-[~) I (. UNITED STATES ENVIRONMENTAL PROTECTIO""" AGENCY Mr. Thomas W. Isaac Senior Regulatory specialist Stepan Company 22 W. Frontage Rd

( c (Company name) quality guaranteed (symbol). We're committed to your satisfaction and guarantee the quality of this product. Contact us at (phone number), or (web address). Please have package available.

(NOTE TO REVIEWER: The following statements are optional and may appear anywhere on the label)

Additional marketing claims:

disinfects [odor causing] [common] [household] [kitchen -and/or-bathroom] bacteria t

maximum cleaning, minimum effort

easy reach-in dispensing

easy to [carry] [use] around the house

easy to store [can] [canister]

convenient [can] [canister] storage

one side to scrub, the other side to wipe!

for all household surfaces, indoor and outdoor

great for clean-up at school, daycare or community center

sanitizes [TV] [OVO] [Video Game] remote controls

uses [x]% less plastic than other [cans] [canisters] [in the market]

uses [x]% less packaging than [multipacks with trays] [traditional multipacks of]- similar products

uses [x]% recycled materials in the packaging

packaging made from [x]% renewable resources

LitePak ™ is a trademark of Alltrista Plastics, LLC, dba Jarden Plastic Solutions

(Uses) (X%) less (material) (plastic) (packaging) than (other) (similar size) (cans) (containers) (packages) (in the market)

Bonus pack (!)

Bonus size (!)

(x) wipes (trial) (travel) pack (included)

(Back-to-school) (spring cleaning) (variety)(special) (bundle) (bonus) (multi) (pack)

(Larger) (bigger) (thicker) (textured) (size) (sheet) (wipe) (cloth)

(Improved) (better) dispensing

Package is 100% recyclable

Stepan Company Northfield, IL 60093 EPA Reg. No. 1839-190 (page 14 of 14)

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