us epa, pesticide product label, frontline plus for dogs ...sep 02, 2014 · frontline plus for...

C miUNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

September 2, 2014

Ms. Cassie AlexanderAssociate Manager, Regulatory AffairsMerial Limited ,3239 Satellite Boulevard, Building 500Duluth, GA 30096-4640

Subject: Label Notification per PRN 98-10 - Addition of Product Authentication StickerProduct Name: FRONTLINE® Plus For DogsEPA Registration Number: 65331 -5Application Date: August 8, 2014Decision Number: 494214

Dear Ms. Alexander:

The Agency is in receipt of your Application for Pesticide Notification under PesticideRegistration Notice (PRN) 98-10 for the above referenced product. The Registration Division(RD) has conducted a review of this request for its applicability under PRN 98-10 and finds thatthe action requested falls within the scope of PRN 98-10.

The label submitted with the application has been stamped ."Notification" and will beplaced in our records.

If you have any questions about this letter, please contact Mr. Carmen J. Rodia, Jr. at(703) 306-0327 or via e-mail at Rodia.Carmen&,eya.sov.

Sincerely, f

Richard GebkenProduct Manager 10Insecticide BranchOffice of Pesticide ProgramsDate: September 2, 2014

065331-00005 D494214

Ptette raid instruction* on nvena baton como/atfng form.

. ' JrintForrri'; • jForm Approved, OMB No. 2070-0060. Acoroval exoirea 2-28-

vvEPAUnited States

Environmental Protection AgencyWaahinston, DC 2046O X

RegistrationAmendmentOther

OPP Identifier Number

Application for Pesticide - Section I1. Company/Product NumberMerial Limited/65331-5

4. Company/Product (Name)Frontline Plus For Does

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

Merial Limited3239 Satellite Blvd., Bid. 500Duluth, GA 30096

Check if this is a new address

2. EPA Product ManagerRichard Gebken

PM*10

C C tj 03. 'Proposed Classification

X 1 C4onc Restricted£ C C C C C6 o r

6. Expedited Reveiw. In accordance with°F!FRA Sectionc|(c|{0){b)(il, my product is similar or identical in cotrvp^jctfon and, labeling

r ' c c o c o

Product Name

Section - II

x

Amendment - Explain below.

Resubmission in response to Agency letter dated.

Notification - Explain below.

Final printed labels in repsonse toAgency letter dated"Ma Too" Application.

Other - Explain below.

Explanation: Use additional page(s) if necessary. (For section I and Section II.)

Notification of Facsimile Labeling including product authentication sticker.This notification is consistent with the provisions of PR Notice 98-10 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the labelingor the confidential statement of formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. 1further 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 of FIFRA and Imay be subject to enforcement action and penalties under sections 12 and 14 of FIFRA.

Section - III1. Material This Product Will Bo Packaged In:

Child-Resistant Packaging Unit Packaging

X Yes X Yes

No No

.._ . If "Yes" No. per* Certification must unit Packaging wgt. containebe submitted 6 oz. i , 3 anc

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

D rvi om:Label I I Container

6. Manner in Which Label is Affixed to Product LitfPa|Sta

Water Soluble Packaging 2. Type of Container

Yes Metal-i- V en *•v L^xt ^ fiasuc

GlassIf "Yes" No. per Paper

r Package wgt container Other (Specify)

<6 ' 'detail Container 5. Location of Label Directions

,0.045,0.091 and 0.1 36 fl. oz. ' 1 V 1 S" ^^liX 1 On Labeling accompaning product

mgraph [X] Other Printed>er glued —netted

Section - IV1 . Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.)

NameCassie Alexander

Title • Telephone No. (Include Area Code)Associate Manager, RAN. America 678-638-3753

Certification1 certify that the statements 1 have made on this form and all attachments thereto are true, accurate and complete.1 acknowledge that any knowlinglly false or misleading statement may be punishable by fine or imprisonment orboth under applicable law.

2. Signature

4. Typed Name

Cassie Alexander

3. Title

Associate Manager, RA N.America

5. Date

6. Date ApplicationReceived

(Stamped)

EPA Form 6670-1 (Rev. 3-941 Previous editions are obsolete. White - EPA FB« Coov (oiigkmll YeOow - AppBcant Co

' i V.V1,---, r.iUi;?,1,. J.«:»-.; 3-1.1- -;W--<!'- '

MGRIAL

A SANOFI COMPANY

3239 Satellite Blvd j<•• <Dfj[*uth. GA 30096

V?- • '-

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t o r e

Cassie AlexanderAssociate MangerRegulatory Affairs North AmericaTel: 678-638-3753Fax: 678-638-3707

August 8, 2014

Mr. Richard GebkenProject Manager, Registration DivisionOffice of Pesticide Programs (7505P)U.S. Environmental Protection AgencyRoom S-4900, One Potomac Yard2777 South Crystal DriveArlington, VA 22202-4501

SUBJECT: FRONTLINE® Plus for Cats, EPA Reg. No. 65331-4FRONTLINE® Plus for Dogs, EPA Reg. No. 65331-5

RE: Submission of Labeling Notification for inclusion of a product authenticationsticker .

Mr. Gebken:

Merial Limited (Merial) hereby provides a notification with facsimile labeling for theaforementioned Frontline products to provide for the inclusion of a productauthentication sticker to the back panel of the product carton. Use of the sticker providesa noticeable marking that demonstrates authenticity of Merial product. No other labelingchanges have been made.

Please find enclosed amended facsimile labeling in Attachments 1 and 2. Actual cartonsamples with the product authentication sticker attached is provided in Attachment 3 sothat you can see the holographic nature of the sticker.

If you have any questions regarding this submission or require any additionalinformation, please do not hesitate to contact me by phone at 678-638-3753 or by emailat [email protected].

Sincerely,

Cassie AlexanderAssociate ManagerMerial LimitedRegulatory Affairs NA

Enclosures: EPA Form 8570-1 for each productAttachment 1: One copy of facsimile labeling for Frontline Plus for Cats,

EPA Reg. No. 65331-4Attachment 2: One copy of facsimile labeling for Frontline Plus for Dogs,

EPA Reg. No. 65331-5Attachment 3: Two original cartons with original sticker

Frontline Plus for Cats, EPA Reg. No. 65331-4Frontline Plus for Dogs, EPA Reg. No. 65331-5

Merial Limited is a company limited by shares registered in England and Wales (registered number 3332751) with a registered office at PO Box 327.Sandringham House. Sandringham Avenue. Hartow Business Park. Hartow. Essex CM19 5QA. England, and domesticated in Delaware. USA as Merial Lie!

SEP 02

SEP U 2

How to Apply

FRODOGS

Stepl.OPEN ApplicatorHold upright with foil side toward youand snap applicator tip.

Step 2.APPLY FRONTLINE PlusPart the dog's hair between theshoulder blades. Place the applicator tipjust above the skin and squeeze. Applyentire contents of the applicator in asingle spot directly onto the dog's skin.Do not apply on top of the hair coat.Avoid contact with treated area until dry.Do not allow your dog to ingest theproduct. Do not apply to dogs weighingless than 5 Ibs or younger than 8 weeksof age. Do not use more than oneapplication per dog per month.

Questions or Comments?Call: 1-800-660-1842,Monday-Friday, 8am-8pm EST orvisit us at www.FRONTLINE.com

Kills fleas, flea eggs & larvae,ticks & chewing lice

• Fast-acting• Long-lasting• Waterproof

nil:nelhoprene:

9.8%8.8%

81 4%rocu.- 100%NET CONTENTS: 1-0.023 J oz (0.67 mL) applicator1 monthly doso

Kills ticks, including those that maytransmit Lyme disease

EPA Reg. No. 65331-5

FOR

DOGS

For use ONLY onDOGS & PUPPIES8 Weeks or Olderand _ _

Ibs

EPA Est. 6533 l-FR-2MADE IN FRANCE

See inside panels for FIRST AIDand PRECAUTIONARYstatements.

Technical area:' No print except prod, barcode * 3 9 0 . 6 8 3 0 *

f f-l -1 fTBmatmmmUHmimmili ^ ^ ^ n M Marketing approval : Requlatorv aoproval : * . . *

e64le:E053I906830fPRODUCT: FRT PLUSNOTICE SINGLE CH1ENS SRECTO

COUNTRY: United States of Amenta (USA)

Dimensions: 'mm * in * 112 • Plee 88 x 112inchfts=

INITIALS:LYON SJ « NSeVERSION - DATE:A 17/07/13 16h20 B 22/07/13 Mh29C 08/08/13 COMPOSER RH llhOO

CANCEL AND

REPLACE: 053 906007

rwrffliippij!

| Please use the official PAfmjNE® (P) matching• system Far an accurate color representation.

COMPLETENAME:

DATE +

SIGNATURE:

COMPLETE o c c c o o 1

NAME: c '• c i L ,c c c c c c

DATE +SIGNATURE: <- c

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b°OGSFor use ONLYm DOGS * PUPPIES 8 weeks orolder and weighing at least 5 Ibs.: Fast-acting,long-lasting, waterproof treatment and controlof fleas, flea eggs & larvae, ticks, chewing lice,and sarcoatic mites.ACTIVE INBREDHNTSflpronil: 9.8%CS>methoprene 8.8%INERT INOREDIENTS 81.4%TOTAL 100.0%KEEP OUT OF REACH OF CHILDREN

CAUTIONFRONTLINE' Plus for Dogs:Fleas• Kills fleas, flea eggs and flea larvae• Prevents all flea stages (eggs, larvae, pupae)

tram developing• Stops existing infestations and prevents

establishment of new infestations• Kills fleas which may cause flea allergy

v dermatitisTicks• Kills all life stages of licks (larvo, nymph ond

adult), including brown dog ticks(Rhipicephalus sanguineus). American dogticks (Dermorantof mriabilis), lone star ticks(Amblyomma americanum) and deer ticks(todes scapularis)

• Kills ticks that may transmit Lyme disease.Rocky Mountain Spotted Fever,hoemobartonellosis, ehrlichiosis, babesiosis.anoplasmosis and other tick-borne diseases

Lice• Rapidly eliminates chewing lice infestationsMrtes• Aids in control of sarcoptic mange infestationsFRONTLINE Plus Is approved for use onall dogs. Including:• Breeding, pregnant, and lactoting bitches• Puppies as young as 8 weeks and weighing at

least 5 Ibs.

One spot application Is all that's needed:FRONTLINE Plus spreads from the single point ofapplication, rapidly covering the entire dog andlocalizing in the hair, on the surface of the skin andin the sebaceous glands. These glands act as areservoir, continuously replenishing FRONTLINEPlus onto the skin ond hair coot, so it keepsworking even If the dog gets wet.Fleas, ticks and chewing lice are killed quickly aftercoming into contact with a treated dog. Fleas andticks do not need to bite the dog in order to die.DIRECTIONS FOR USEIt Is a violation of Federal Law to use this product ina manner inconsistent with its labeling. Do notallow children to apply product. TO PREVENTHARM TO YOU AND YOUR PET. READENTIRE LABEL AND DIRECTIONS BEFOREEACH USE. FOLLOW ALL DIRECTIONS ANDPRECAUTIONARY STATEMENTS CAREFULLY.USE ON DOGS ONLY. DO NOT USE ONRABBITS. DO NOT USE ON OTHER ANIMALS.To kill fleas, flea eggs & larva, ticks, and chewinglice apply FRONTLINE Plus for Dogs as follows:• OPEN ApplicatorHold upright with toll side toward you and snapapplicator tip.• APPLY FRONTLINE PlusPart the dog's hair between the shoulder blades.Place the applicator tip just above the skin andsqueeze. Apply entire contents of the applicator in asingle spot directly onto the dog's skin. Do not applyon top of the hair coat. Avoid contact with treatedarea until dry. Do not allow your dog to ingest theproduct. Do not apply to dogs weighing less than 5 Ibsor younger than 8 weeks of age. Do not use more thanone application per dog per month.FRONTLINE Plus Is approved for use on all dogs,including breeding, pregnant, and ioctating bitchesond puppies os young as 8 weeks.FRONTLINE Plus remains effective even afterbathing, water immersion, or exposure to sunlight.FREQUENCY OF APPLICATIONWhen used monthly, FRONTLINE Pluscompletely breaks the flea life cycle and controlstick and chewing lice infestations. Do not reapplyFRONTLINE Plus for 30 days.FRONTLINE Plus kills odult fleos, flea eggs, andflea larvae for up to three months. FRONTLINEPlus also prevents development of all flea stages

for up to three months. FRONTLINE Plus concontrol fleos for up to three months, however, ifthere is a high risk of reinfeslotion or if the pet hasfleas which may cause flea allergy dermatitis, oonce monthly application may be needed.FRONTLINE Plus kills ticks for at leqst onemonth, A once monthly application ,isrecommended where tick control is needed.FRONTLINE Plus kills all life stages of ticks(larva, nymph ond odult). FRONTLINE Plus killsticks that moy transmit Lyme disease. RockyMountain Spotted Fever, ehrlichipsis, babesiosis,anaplasmosis and other tick-borne diseases.FRONTLINE Plus kills chewing lice for at leastone month. A once monthly application isrecommended where chewing lice control isneeded.FRONTLINE Plus aids in the control of sarcopticmange infestations. Multiple monthly treatmentsore recommended for the elimination of mites.STORAGE AND DISPOSAL

.Do not contaminate water, food, or feed by storageand disposal.STORAGE. Store unused product in originalcontainer, out of reoch of children and onimols.PESTICIDE DISPOSAL. If partly filled: Callyour local solid waste agency or 1-800-CLEANUPfor disposal instructions. Never place unusedproduct down any indoor or outdoor drain.CONTAINER DISPOSAL. II empty:Nonrefillable container. Do not reuse or refill thiscontainer. Place in-trash or offer for recycling ifavailable.FIRSTAIDHove the product container or lobel with you whencalling a poison control center or doctor, or goingfor treatment.IF SWALLOWED: Coll a poison control center ordoctor immediately for treatment odvice. Haveperson sip a glass of water if able to swallow. Donot induce vomiting unless told to so by a poisoncontrol center or doctor. Da not give anything bymouth to an unconscious person.IF IN EYES: Hold eye open ond rinse slowly ondgently with water for 15-20 minutes. Removecontact lenses, if present, after the first 5 minutes,then continue rinsing eye. Call a poison controlcenter or doctor for treatment advice.

IF ON SKIN OR CLOTHING: Take offcontaminated clothing. Rinse skin immediately withplenty of water for-15-20 minutes. Call a poisoncontrol center or doctor for treatment advice.PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS. CAUTION.Harmful if swallowed. Causes eye irritation. Avoidcontact with skin, eyes or clothing. Wash handsthoroughly with soap ond water after handling andbefore eating, drinking; chewing gum, or usingtobacco.HAZARDS TO DOMESTIC ANIMALS.For external use only. Do not use on puppies under 8weeks of age and 5 Ibs. Individual sensitivities, whilerare, moy occur ofler using any pesticide product.SIDE EFFECTS: Pets may experience sometemporary irritation at the site of application. Ifsigns persist or become more severe within a fewdays of application, consult a veterinarianimmediately.If your dog has an unusual reaction to the initialapplication, consult a veterinarian before repeatingtreatment. Certain medications con interact withpesticides. Consult o veterinarian before using onmedicated, debilitated or aged animals. Call1 -800-660-1842, Monday-Friday, 8am-8pm EST.PHYSICAL OR CHEMICAL HAZARDSCOMBUSTIBLE: Do hot use or store near heat oropen flame.HOW SUPPLIEDFor easy ond convenient treatment, FRONTLINEPlus for Dogs is available in sizes for use ONLYon small dogs and puppies 8 weeks or older and5-22 Ibs., medium dogs ONLY 23-44 Ibs.. largedogs ONLY 45-88 Ibs., and extra-lorge dogs ONLY89-132 Ibs.WARRANTYTo the extent consistent with applicable law, sellermokes no warranty, expressed or Implied,concerning the use of this product other thanindicated on the label. Buyer assumes all risk ofuse and handling of this mcte.'iti fthen such useand handling are contralto label instructions.Merlal Limited c o o u

3239 Satellite Blvd. Duluth, CV300C6-4640, USA©FRONTLINE is o register J trade'lngrtJof Merial.©2013 Merial Limited. Duluttf&.All'rights reserved.

M€RIAL GRAPHIC ARTWORK APPROVAL

PRODUCT: FRT PIUSNOTICE SINGLE CHIENSSVERSO

COUNTRY: United States or Amertcz (USA|

Dimensions:mm = 176 x 112-Pliie 88x112

Inchess '

INITIALS:LYON S) W NSeVERSION - DATE:A 17/07/13 16h20 8 22/07/13 14h29C 08/06/13 COMPOSER RH llhOO

CANCEL ANDREPLACE: 053 906007

I Pleate use Che official PANTONE® (P) matching• system for an accurate color representation.

Marketing approval:COMPLETENAME:

DATE*SIGNATURE:

Regulatory approval:COMPLETE c'NAME:

DATE +SIGNATURE: ;

flll

Technical area:No print except prod, barcode

How to Apply

FROMTLJHEStepl.OPEN ApplicatorHold upright with toil side toward YOUand snap applicator tip.

Step 2.APPLY FRONTLINE PlusPart the dog's hair between theshoulder blades. Place the applicator tipjust above the skin and squeeze. Applyentire contents of the applicator in asingle spot directly onto the dog's skin.Do not apply on top of the hair coat.Avoid contact with treated area until dry.Do not allow your dog to ingest theproduct. Do not apply to dogs weighingless than 23 Ibs. or younger than8 weeks of age. Do note use more thanone application per dog per month.Questions or Comments?Call: 1-800-660-1842,Monday-Friday, 8am-8pm EST orvisit us at www.FRONTLINE.com

* 3 9 0 6 8 3 1 *

M6RIALe6Hgl053M06.83.lPRODUCT: FRT PLUSNOTICE SINGLE CHIENSHRECTO

COUNTRY: United Stales of Ameria (USA)

Dimensions:mm * 176 1 112 - Nice 88 x 112Inches^ i

INITIALS:SI A] NSe

VERSION - DATE:A 17/07/13 ISM! B 22/07/13 14h23C 08/08/13 COMPOSER RH llhOO


Kills fleas, flea eggs & larvae,ticks & chewing lice•. Fast-acting• Long-lasting• Waterproof

Rpronil: 9.8%p^tnethoptene: 8.8%

TOTAL: .'.."'."'."™100%NET CONTENTS: 1 -0.045 fl oz (1.34 ml) opplicotor1 monthly do*«

FOR

DOGSKills ticks, including those that maytransmit Lyme disease

EPA Reg. No. 65331-5EPA Est. 6533 l-FR-2For use ONLY

on DOGS


Market inn annrm/al : Rpnulatoru ju-.nrr.val • * . .

f Please use the official PANTONE® (P) matching• system for an accurate color representation.

COMPLETENAME:

DATE +SIGNATURE:

COMPLETENAME:

DATE +SIGNATURE:

i <L C t, C <-

c

FROFOffDOGS

For use OMKon DOSS * PUPPIES 8 weeks orolder and weighing at least 23 IDS.: Fast-acting,long-lusting, waterproof treatment and controlof flan, flea eggs & larvae, ticks, chewing lice,and sarcoptic mites.ACTIVE INOKEDIENTSfipror.il: ».8%CS>methoprene 8.8%INERT INOREDIENTS 81.4%TOW. 100.0%KEEP OUT OF REACH OF CHILDREN

CAUTIONFRONTLINE9 Plus for Dogs:Fleas• Kills fleas, flea eggs and flea laivae• Prevents all flea stages (eggs, larvae, pupae)

frorn developing• Stops existing infestations and prevents


dermatitisTicks• Kills oil life stages of ticks (larva, nymph and

adult), including brown dog ticks(Rnipicephalus sanou/neusJ.American dogticks (Dermacentor variabilis), lone star ticks(Amblyomma americonum) and deer ticks(Wdes scoputoris)

• Kills ticks that may transmit Lyme disease,Rocky Mountain Spotted Fever,hoemobortonellosis, ehrlichiosis, babesiosis,anoplasmosis and other tick-borne diseases

Lice• Rapidly eliminates chewing lice infestationsMites• Aids in control of sarcoptic mange infestationsFRONTLINE Plus is approved for use onall dogs, including:• Breeding, pregnant, and lactating bitches• Puppies as young as 8 weeks and weighing at

least 23 Ibs.

One spot application is all thafs needed:FRONTLINE Plus spreads from the single point ofapplication, rapidly covering the entire dog andlocalizing in the hair, on the surface of the skin andin the sebaceous glands.These glands act as a•reservoir, continuously replenishing FRONTLINEPlus onto the skin and hair coot, so it keepsworking even if the dog gels wet.Fleas, ticks and chewing lice ore killed quickly aftercoming into contact with a treated dog. Fleas andticks do not need to bite the dog in order to die.DIRECTIONS FOR USEIt is a violation of Federal Law to use this product ina manner inconsistent with its labeling. Do notallow children to apply product. TO PREVENTHARM TO YOU AND YOUR PET, READENTIRE LABEL AND DIRECTIONS BEFOREEACH USE. FOLLOW ALL DIRECTIONS ANDPRECAUTIONARY STATEMENTS CAREFULLY.USE ON DOGS ONLY. DO NOT USE ON-RABBITS. DO NOT USE ON OTHER ANIMALS.To kill fleas, flea eggs & larva, ticks, and chewinglice apply FRONTLINE Plus for Dogs as follows:• OPEN ApplicatorHold upright with foil side toward you and snapapplicator tip.• APPLY FRONTLINE PlusPart the dog's hair between the shoulder blades.Place the applicator tip just above the skin andsqueeze. Apply entire contents of the applicator in asingle spot directly onto the dog's skin. Do not applyon top of the hair coat. Avoid contact with treatedarea until dry. Do not allow your dog to ingest theproduct. Do not apply to dogs weighing less than23 Ibs. or younger thon 8 weeks of age. Do not usemore than one application per dog per month.FRONTLINE Plus is approved for use on all dogs,including breeding, pregnant and lactoting bitchesand puppies as young as 8 weeks.FRONTLINE Plus remains effective even afterbathing, water immersion, or exposure to sunlight.FREQUENCY OF APPLICATIONWhen used monthly, FRONTLINE Pluscompletely breaks the flea life cycle and controlstick and chewing lice infestations. Do not reapplyFRONTLINE Plus for 30 days.FRONTLINE Plus kills adult fleas, flea eggs, and

•flea larvae for up to three months. FRONTLINEPlus also prevents development of all flea stages

for up to three months. FRONTLINE Plus concontrol fleas for up to three months, however, ifthere is a high risk of reinfestation or if the pet hasfleas which may cause fleo allergy dermatitis, aonce monthly application may be needed.FRONTLINE Plus kills ticks for at least onemonth. A once monthly application isrecommended where tick control is needed.FRONTLINE Plus kills all life stages of ticks(larva, nymph and adult). FRONTLINE Plus killsticks that may transmit Lyme disease. RockyMountain Spotted Fever, ehrlichiosis, babesiosis,anaplasmosis and other tick-borne diseases.FRONTLINE Plus kills chewing lice for at leastone month. A once monthly application isrecommended where chewing lice control isneeded.FRONTLINE Plus aids in the control of sarcopticmange infestations. Multiple monthly treatmentsare recommended for the elimination of mites.STORAGE AND DISPOSALDo not contaminate water, food, or feed by storageand disposal.STORAGE. Store unused product in originalcontainer, out of reach of children and animals.PESTICIDE DISPOSAL. II partly ailed: Callyour local solid waste agency or 1-800-CLEANUPfor disposal instructions. Never place unusedproduct down any indoor or outdoor drain.CONTAINER DISPOSAL. If empty:Nonrefillable container. Do not reuse or refill thiscontainer. Place in trash or offer for recycling ifavailable.FIRSTAIDHave the product container or label with you whencalling a poison control center or doctor, or goingfor treatment.IF SWALLOWED: Call a poison control center or

.doctor immediotely for treatment advice. Haveperson sip a glass of water if able to swallow. Donot induce vomiting unless told to so by a poisoncontrol center or doctor. Do not give anything bymouth to an unconscious person.IF IN EYES: Hold eye open and rinse slowly andgently with water tor 15-20 minutes. Removecontact lenses, if present, after the first 5 minutes,then continue rinsing eye. Call a poison controlcenter or doctor for treatment advice.

IF ON SKIN OR CLOTHING: Take offcontaminated clothing. Rinse skin immediately withplenty of water for 15-20 minutes. Call a poisoncontrol center or doctor for treatment advice.PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS. CAUTION.Harmful if swallowed. Causes eye irritation. Avoidcontact with skin, eyes or clothing. Wash handsthoroughly with soap and water after handling andbefore eating, drinking, chewing gum, or usingtobacco.HAZARDS TO DOMESTIC ANIMALS.For external use only. Do not use on puppies under 8weeks of age and 23 Ibs. Individual sensitivities, whilerare, may occur otter using any pesticide product.SIDE EFFECTS: Pets may experience sometemporary irritation at the site of application. Ifsigns persist or become more severe within a fewdays of application, consult a veterinarianimmediately.Ifyour dog has an unusual reaction to the initialapplication, consult a veterinarian before repeatingtreatment. Certain medications can interact withpesticides. Consult a veterinarian before using onmedicated, debilitated or aged animals Call1 -800-660-1842, Monday-Friday, 8am-8pm EST.PHYSICAL OR CHEMICAL HAZARDSCOMBUSTIBLE: Do not use or store near heat oropen flame.HOW SUPPLIEDFor easy and convenient treatment, FRONTLINEPlus for Dogs is available In sizes for use ONLYon small dogs and puppies 8 weeks or older and

-5-22 Ibs., medium dogs ONLY 23-44 Ibs., largedogs ONLY 45-88 Ibs., and extra-large dogs ONLY89-132 Ibs.WARRANTYTo the extent consistent with applicable law. sellermakes no warranty, expressed or implied,concerning the use of this product other thanindicated on the label. Buyer assumes all risk ofuse and handling of this mctejicl t/hen such useand handling ate contraryjto label inductions.Mortal Limited c o c o3239 Satellite Blvd. Duluth, £^30006-4640, USA©FRONTLINE is a registerejYrodc.TOr'i-.of Merial.©2013 Meriol Limited, Duluth;e\.AIIr.fghts reserved.

MGRIAL GRAPHIC ARTWORK APPROVALMarketing approval: Regulatory approval: >

PRODUCT: FRT PLUSNOTICE SINGLE CHIENSMVERSO

COUNTRY: United States of America (USA)

Dimensions:mm = 176 x 112 - Pllee 68 x 112fnchess

INITIALS:S) a NSeVERSION • DATE:A17/07/13 16M2 B 22/07/13 14h23C 08/08/13 COMPOSER RHllhOO

'CANCEL ANDREPLACE: 053 906008

I Please use Che official PANTONE® (P) matching• system for an accurate color representation.

COMPLETENAME:

DATE +SIGNATURE:

COMPLETENAME:

DATE*SIGNATURE:

c r

How to Apply

FRONTLINE'Stepl.OPEN ApplicatorHold upright with toil side toward youand snap applicator tip.

Step 2./WmRONTLINEPIusPart the dog's hair between theshoulder blades. Place the applicator tipjust above the skin and squeeze. Applyentire contents of the applicator in asingle spot directly onto the dog's skin.Do not apply on top of the hair coat.Avoid contact with treated area until dry.Do not allow your dog to ingest theproduct. Do not apply to dogs weighingless than 45 Ibs. or younger than8 weeks of age. Do not use more thanone application per dog per month.Questions or Comments?Call: 1-800-660-1842,Monday-Friday, 8am-8pm EST orvisit us at www.FRONTLINE.com

Kills fleas, flea eggs & larvae,ticks & chewing lice• Fast-acting• Long-lasting• Waterproof


ACTIVE INSBEDICNTS:Rpronil: 9.8%j&melhoprene: 8.8%

TOTAL .'..'.™™.ldo%NET CONTENTS: 1-0.09! 102 (2.61 mL) oppliartor1 monthly dose

FOR

DOGS

For use ONLYon DOGS

45,o88Ibs

EPA Reg. No. 65331-5EPA Est. 65331-FR-2MADE IN FRANCE


»Technical area:No print except prod, barcode

M6RIAL GRAPHIC

* 3 9-0 6 8 3 2 *

APPROVAL

PRODUCT! FRT PLUSNOTICE SINGH CHIBtSlRECTO


Dimensions:mm = 176 x 112 - Pllfe 88 x 112lnches=

INITIALS:SI U NSeVERSION - DATE:A 17/07/13 16h58 B 22/07/13 14h35C 08/08/13 COMPOSER RH HhOO

CANCEL AND

REPLACE: 053 906009I Please use the official PANTONE® (p) matching• system rcr an accurate color representation.

r

FRONTUHE'V&SS

For use (WiPon DOCS 4 PUPP/K 8 weeks orolder and weighing at least 45 IDS.: Fast-acting,long-lasting, waterproof treatment and controlof fleas, flea egg: & larvae, licks, chewing lice,and sarcoptlc mites.ACTIVE INGREDIENTSfipronil: 9.8%(sj-mettioprene 8.8%INERT INGREDIENTS 81.4%TOHl 100.0%KEEP OUT OF REACH OF CHILDREN

CAUTIONFRONTLINE* Plus for Dogs:Fleas• Kills fleas, flea eggs and flea larvae• Prevents all flea stages (eggs, larvae, pupae)

from developing• Slops existing infestations and prevents


dermatitisTicks• Kills all life stages of ticks (larva, nymph and

adult), including brown dog ticks(Rhiplcephalus sanguineus). American dogticks (Dermacentoryariabilis), lone star ticks(Amblyomma americanum) and deer ticks(Ixodes scapularis)

• Kills ticks that may transmit Lyme disease,Rocky Mountain Spotted Fever,haemobartonellosis, ehrlichiosis, babesiosis.anaplasmosis and other tick-borne diseases

Lice• Rapidly eliminates chewing lice infestationsMites• Aids in control of sarcoptic mange infestationsFRONTLINE Plus is approved for use onall dogs, including:• Breeding, pregnant, and lactating bitches• Puppies as young as 8 weeks and weighing at

least 45 Ibs. >

One spot application Is all thafs needed:FRONTLINE Plus spreads from the single point ofapplication, rapidly covering the entire dog andlocalizing in the hair, on the surface of the skin andin the sebaceous glands.These glands act as oreservoir, continuously replenishing FRONTLINEPlus onto the skin and hair coat, so it keepsworking even if the dog gets wet.Fleos, ticks and chewing lice are killed quickly aftercoming into contact with a treated dog. Fleas andticks do not need to bile the dog In order to die.DIRECTIONS FOR USEIt is a violation of Federal Law to use this product ina monner inconsistent with its labeling. Do notallow children to opply product. TO PREVENTHARM TO YOU AND YOUR PET, READENTIRE LABEL AND DIRECTIONS BEFOREEACH USE. FOLLOW ALL DIRECTIONS ANDPRECAUTIONARY STATEMENTS CAREFULLY.USE ON DOGS ONLY. DO NOT USE ONRABBITS. DO NOT USE ON OTHER ANIMALS.To kill fleos, flea eggs & larva, ticks, and chewinglice apply FRONTLINE Plus for Dogs as follows:• OPEN ApplicatorHold upright with foil side toward you and snapapplicator tip.• /APPiVFRONTUNE PlusPah the dog's hair between the shoulder blades.Place the applicator tip just above the skin andsqueeze. Apply entire contents of the applicator in asingle spot directly onto the dog's skin. Do not applyon top of the hair coat. Avoid contact with treated ,area until dry. Do not allow your dog to ingest theproduct. Do not apply to dogs weighing less than45 Ibs. or younger than 8 weeks of age. Do not usemore than one application per dog per month.FRONTLINE Plus is approved for use on all dogs,including breeding, pregnant, and lactating bitchesand puppies as young as 8 weeks.FRONTLINE Plus remains effective even afterbathing, water immersion, or exposure to sunlight.FREQUENCY OF APPLICATIONWhen used monthly, FRONTLINE Pluscompletely breaks the fleo life cycle and controlstick and chewing lice infestations. Do not reapplyFRONTLINE Plus for 30 doys.FRONTLINE Plus kills adult fleas, flea eggs, andflea larvae for up to three months. FRONTLINEPlus also prevents development of all fleo stages

for up to three months. FRONTLINE Plus cancontrol fleas for up to three months, however, ifthere is a high risk of reinfestation or if the pet hasfleas which may cause fleo allergy dermatitis, aonce monthly application may be needed.FRONTLINE Plus kills ticks for at least onemonth. A once monthly application isrecommended where tick control is needed.FRONTLINE Plus kills all life stages of ticks(larva, nymph and adult). FRONTLINE Plus killsticks that may transmit Lyme disease. RockyMountain Sported Fever, ehrlichiosis, babesiosis,anaplasmosis and other tick-borne diseases.FRONTLINE Plus kills chewing lice for at leastone month. A once monthly application isrecommended where chewing lice control isneeded.FRONTLINE Plus aids in the control of sarcopticmange infestations. Multiple monthly treatmentsare recommended for the elimination of mites.STORAGE AND DISPOSALDo not contaminate water, food, or feed by storageand disposal.STORAGE. Stare unused product in originalcontainer, out of reach of children and animals.PESTICIDE DISPOSAL If partly filled: Callyour local solid waste agency or 1-800-CLEANUPfor disposal instructions. Never place unusedproduct down any indoor or outdoor drain.CONTAINER DISPOSAL. If empty:Nonrefillable container. Do not reuse or refill thiscontainer. Place in trash or otter for recycling ifavailable.FIRST AIDHave the product container or label with you whencalling a poison control center or doctor, or goingfor treatment.IF SWALLOWED: Call a poison control center ordoctor immediately for treatment advice. Haveperson sip a glass of water if able to swallow. Donot induce vomiting unless told to so by a poisoncontrol center or doctor. Do not give anything bymouth to an unconscious person.IF IN EYES: Hold eye open ond rinse slowly andgently with water for 15-20 minutes. Removecontact lenses. If present, after the first 5 minutes,then continue rinsing eye. Coll a poison controlcenter or doctor for treatment advice.

IF ON SKIN OR CLOTHING: Take offcontaminated clothing. Rinse skin immediately withplenty of water for 15-20 minutes. Call a poisoncontrol center or doctor for treatment advice.PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS. CAUTION.Harmful if swallowed. Causes eye Irritation. Avoidcontact with skin, eyes or clothing. Wosh handsthoroughly with soap and water after handling andbefore eating, drinking, chewing gum. or usingtobacco.HAZARDS TO DOMESTIC ANIMALS.For external use only. Do not use on puppies under 8weeks of age and 45 Ibs. Individual sensitivities, whilerare, may occur after using any pesticide product.SIDE EFFECTS: Pets may experience sometemporary irritation at the site of application. Ifsigns persist or become more severe within a fewdays of application, consult a veterinarianimmediately.if your dog has an unusual reaction to the initialapplication,consult a veterinarian before repeatingtreatment. Certain medications can interact withpesticides. Consult o veterinarian before using onmedicated, debilitated or aged animals. Call1 -800-660-1842. Monday-Friday, 8am-8pm EST.PHYSICAL OR CHEMICAL HAZARDSCOMBUSTIBLE: Do not use or store near heat oropen flame.HOW SUPPLIEDFor easy and convenient treatment, FRONTLINEPlus for Dogs is available in sizes for use ONLYon small dogs and puppies 8 weeks or older and5-22 Ibs., medium dogs ONLY 23-44 Ibs., largedogs ONLY 45-88 Ibs., and extra-large dogs ONLY89-132 Ibs.WARRANTYTo the extent consistent with applicable law, sellermakes no warranty, expressed or implied,concerning the use of this product other thanIndicated on the label. Buyer assumes all risk ofuse and handling of this mctt.ni.! r.tien such useand handling are controry.to label instructions.Merlal Limited c c c c

3239 Satellite Blvd. Duluth, eyooC6-4640. USA©FRONTLINE is a registered ttod&noitof Merial.©2013 Merial Limited, Dulult1,;£t.AlFlights reserved.

^ tt fmUmtEmmimmiiiili ^ ^ n t M Marketing approval: Requlaterv approval: *••*ITI rmij* %> laKrtrnii- MM vvwr\rv «rrr\vjv«i_

Gbide:S053i 906832i;sPRODUCT: FRT PLUSNOTICE SINGLE CHIENS IVERSO


Dimensions:mm = 176 x 112 - Pllee 88 x 112Inches^

INITIALS:S) A) NSeVERSION • DATE:A 17/07/13 16hS8 B 2Z/07/13 Mh35C 08/08/13 COMPOSER RH IIMO


1 Please use tne official PANTONE® (P) matching• system for an accurate color representation.

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How to Apply

FRONTLINEFORDOGS

OPEN ApplicatorHold upright with foil side toward youand snap applicator tip.

Step 2.

APPLY FRONTLINE PlusPart the dog's hair between theshoulder blades. Place the applicator tipjust above the skin and squeeze. Applyentire contents of the applicator in asingle spot directly onto the dog's skin.Do not apply on top of the hair coat.Avoid contact with treated area until dry.Do not allow your dog to ingest theproduct. Do not apply to dogs weighingless than 89 ibs. or younger than 8weeks of age. Do not use twoapplicators for dogs weighing more than132 Ibs. Do not use more than oneapplication per dog per month.

Questions or Comments?Call: 1-800-660-1842,Monday-Friday, 8am-8pm EST orvisit us at www.FRONTLINE.com

Technical area:' No print except prod, barcode * 3 9 0 6 8 3 3 ' *

M6RIAL GRAPHIC ARTWORK

PRODUCT: FRT PLUSNOTICE SINGLE CHIENS XLMHO


Dimensions:mm = J76 X 112 -.Pllee 88X112Inchus

INITIALS:SJ A] useVERSION - OMEiA 17/07/13 17hll B 22/07/13 IShOlC 08/08/13 COMPOSER RHllhOO

CANCEL AND

REPLACE: 053 906010

Kills fleas, flea eggs & larvae,ticks & chewing lice• Fast-acting• Long-lasting• Waterproof

ironil: 9.8%(S><Tiefhoprene: 8.8%INERTINSKDIimS: 81.4%mjfL 100%NET CONTEWS: 1-0.136 (I oz (4.02 ml) applicator1 monthly dosa


FOR

DOGS

For use ONLYon DOGS

89132Ibs

EPA Reg. No. 65331-5EPAEsl.65331-FR-2MADE IN FRANCE


1 Please use the official PANTONE® (P) matching• system for an accurate color representation.

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For use ONLY on DOGS & PUPPIES 8 weeks orolder and weighing at least 89 IDS.: Fast-acting,long-lasting, waterproof treatment and controlof fleas, flea eggs & lanoe, tlcte, chewing lice,and sarcoptic mites.ACTIVE IN0RIDIENTSfipronll: 9.8%CS>methoprene 8.8%INlKfmBREDIimS 81.4%TOTAL 100.0%KEEP OUT OF REACH OF CHILDREN

CAUTIONFRONTLINE' Plus for Dogs:Fleas• Kills fleas, flea eggs and flea larvae• Prevents all flea stages (eggs, larvae, pupae)

from developing• Stops existing infestations and prevents


dermatitisTicks• Kills all life stages of ticks (larva, nymph and

adult), including brown dog ticks(Rhipicephalus s0nou/neus),American dogticks (Deimocentorvariobilis), lone star ticks(Amblyommo omericonum) and deer ticks(Ixodes scoputoris)

• Kills ticks that may transmit Lyme disease,Rocky Mountain Spotted Fever,haemobartonellosis, ehrllchiosis, babesiosis,anaplasmosis and other tick-borne diseases

Lice• Rapidly eliminates chewing lice infestationsMrtes• Aids in control of sarcoptic mange infestationsFRONTLINE Plus is approved for use onall dogs, including:• Breeding, pregnant, and lactating bitches• Puppies as young as 8 weeks and weighing at

least 89 Ibs.

One spot application is all thafs needed:FRONTLINE Plus spreads from the single point ofapplication, rapidly covering the entire dog andlocalizing in the hair, on the surface of the skin andin the sebaceous glands.These glands act as areservoir, continuously replenishing FRONTLINEPlus onto the skin and hair coat, so it keepsworking even if the dog gets wet.Fleas,ticks and chewing lice are killed quickly aftercoming into contact with a treated dog. Fleas andticks do not need to bite the dog in order to dje^ _DIRECTIONS FOP USEIt is a violation of Federal Law to use this product ino manner inconsistent with its labeling. Do notallow children to apply product. TO PREVENTHARM TO YOU AND YOUR PET, READENTIRE LABEL AND DIRECTIONS BEFOREEACH USE. FOLLOW ALL DIRECTIONS ANDPRECAUTIONARY STATEMENTS CAREFULLY.USE ON DOGS ONLY. DO NOT USE ONRABBITS. DO NOT USE ON OTHER ANIMALS.To kill fleas, flea eggs & larva, ticks, and chewinglice apply FRONTLINE Pius for Dogs as follows:• OPEN ApplicatorHold upright with foil side toward you and snapapplicotor tip.• APPLY FRONTLINE PiusPart the dog's hair between the shoulder blades.Place the applicator tip just above the skin aridsqueeze. Apply entire contents of the applicator in asingle spot direclly onto the dog's skin, Do not applyon top of.the hair coat.'Avoid contact with treatedarea until dry. Do not allow your dog to ingest theproduct. Do not apply to dogs weighing less than89 Ibs. or younger than 8 weeks of age. Do notuse two applicators for dogs weighing more than132 Ibs. Do not use more than one application perdog per month.FRONTLINE Pius is approved for use on all dogs,including breeding, pregnant, and Mating bitchesand puppies as young as 8 weeks.FRONTLINE Plus remains effective even afterbathing, water immersion, or exposure to sunlight.FREQUENCY OF APPLICATIONWhen used monthly, FRONTLINE Pluscompletely breaks the flea life cycle and controlstick and chewing lice infestations. Do not reapplyFRONTLINE Plus for 30 days.FRONTLINE Plus kills adult fleas, flea eggs, and

flea larvae for up to three, months. FRONTLINEPlus also prevents development of all flea stagesfor up to three months. FRONTLINE Plus cancontrol fleas for up to three months, however, ifthere is a high risk of reinfestation or if the pet hasfleas which may cause flea allergy dermatitis, aonce monthly application may be needed.FRONTLINE Plus kills ticks for at least onemonth. A once monthly application isrecommended where tick control is needed.FRONTLINE Plus kills all life stages of ticks(larva, nymph and adult). FRONTLINE Plus killsticks that may transmit Lyme disease. RockyMountain Spotted Fever, ehrlichiosis, babesiosis,anaplasmosis and other tick-borne diseases.FRONTLINE Plus kills chewing lice for at leastone month. A once monthly application isrecommended where chewing lice control isneeded.FRONTLINE Plus aids in the control of sarcopticmange infestations. Multiple monthly treatmentsare recommended for the elimination of mites.STORAGE AND DISPOSALDo not contaminate water, food, or feed by storageand disposal.STORAGE. Store unused product in originalcontainer, out of reach of children and animals.PESTICIDE DISPOSAL. 11 partly filled: Callyour local solid waste agency or 1-800-CLEANUPfor disposal instructions. Never place unusedproduct down any indoor or outdoor drain.CONTAINER DISPOSAL. If empty:NonrefiHable container. Do not reuse or refill thiscontainer. Place in trash or offer for recycling ifavailable.FIRST AIDHave the product container or label with you whencalling a poison control center or doctor, or goingfor treatment.IF SWALLOWED: Call a poison control center ordoctor immediately for treatment advice. Haveperson sip a gloss of water if able to swallow. Donot induce vomiting unless told to so by a poisoncontrol center or doctor. Do not give anything bymouth to an unconscious person.IF IN EVES: Hold eye open and rinse slowly andgently with water for 15-20 minutes. Removecontact lenses, if present, after the first 5 minutes,then continue rinsing eye. Call a poison controlcenter or doctor for treatment advice.

IF ON SKIN OR CLOTHING: Take offcontaminated clothing. Rinse skin immediately withplenty of water for 15-20 minutes. Call a poisoncontrol center or doctor for treatment advice.PRECAUTIONARY STATEMENTSHAZARDS TO HUMANS.-CAUTION.Harmful if swallowed. Causes eye irritation. Avoidcontact with skin, eyes or clothing. Wash handsthoroughly with soap and watei after handling andbefore eating, drinking, chewing gum, or usingtobacco.HAZARDS TO DOMESTIC ANIMALS.For external use on V. Do not use on puppies under 8weeks of age and 89 Ibs. Individual sensitivities, whilerare, may occur after using any pesticide product.SIDE EFFECTS: Pets may experience sometemporary irritation at the site of application. Ifsigns persist or become more severe within a fewdays of application, consult a veterinarianimmediately.It your dog has an unusual reaction to me initialapplication,consult o veterinarian before repeatingtreatment. Certain medications can interact withpesticides. Consult a veterinarian before using onmedicated, debilitated or aged animals. Call1-800-660-1842, Monday-Friday, 8am-8pm EST.PHYSICAL OR CHEMICAL HAZARDSCOMBUSTIBLE: Do not use or store near heat oropen flame.HOW SUPPLIEDFor easy and convenient treatment, FRONTLINEPlus for Dogs is available in sizes for use ONLYon small dogs and puppies 8 weeks or older and5-22 Ibs., medium dogs ONLY 23-44 Ibs., largedogs ONLY 45-88 Ibs., and extra-large dogs ONLY89-132 Ibs.WARRANTYTo the extent consistent with applicable law, sellermakes no warranty, expressed or implied,concerning the use of this product other thanindicated on the label. Buyer assumes all risk ofuse and handling of this material when such useand handling are contrary to label instructions.Merlal Limited3239 Satellite Blvd. Duluth. GA 30096-4640, USA®FRONTLINE is a registered trademark of Merial.©2013 Merial Limited, Duluth, SA.AII rights reserved.

M6ERIAL GRAPHIC ARTWORK APPROVALCode: 0535906833PRODUCT: FRT PLUSNOTICE SINGLE CHIENS XLVERSO


Dimensions: *mm = 176 x 112 - Pllee 88 x 112

IINITIALS:SI A] NSeVERSION • DATE:A i7/07/n nhn e 22/07/13 ishoiC 08/08/13 COMPOSER RHllhOO


Marketing approvalCOMPLETENAME:

Regulatory approval:

I Please use the official PANTONE® (P) matching• system for an accurate color representation.

DATE +SIGNATURE!

COMPLETENAME:

DATE*SIGNATURE:

us epa, pesticide product label, frontline plus for dogs ...sep 02, 2014 · frontline plus for...

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