I) ltt L J I -- Ll · I) /-ltt -L f) J I u.s. ... Illustration of louse life cycle 5 ... • Summary table for dogs showing number of incidents of each severity code for each route

I) /- ltt - L f) J I

u.s. ENVIRONMENTAL PROTECTION AGENCY

Office of Pesticide Programs

Registration Division (7S0SC)

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460

NOTICE OF PESTICIDE: .ll Registration _ Reregistration (under FIFRA, as amended)

Name and Address of RegIstrant tlDcluae Llr LOae):

Virbac AH, Inc. 3200 Meacham Blvd. Fort Worth, TX 76137

EPA Reg. Number: Date of Issuance:

2382-185 January 14,2011

Term 01 Issuance:

Conditional Time limited registration for 2 years

Name of Pesticide Product:

Effipro Togical Solution for Dogs

'N~t~: Changes 4llapeling diffeIiQg i1) substanqe fro~ t~ ~cePted in co~ecti~nwith' t!li~ registration must 1?e ~bmitted to and accepted 'by the·, .

R~gisttation QiVi.sion p'ri<!r to ~~ ~f,he label m CIl.mme~ce. In a!J.;·~?rreSPOnde!1Ce, ~n this prodU.ct a1w!lYs refe!.·tq '~;'above EPAr~gi~&ation Jiti~!jer: .. •• ~ .J' ~ .,.,. ~, - '> :.'"" • ,,~, 71',. ' ,' .. ',

On the basis of information furnished by the registrant, the above named pesticide is hereby registered/reregistered under the Federal Insecticide, Fungicide

and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In order to protect

health and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration of a pesticide 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 conditionally registered in accordance with FIFRA section 3(c)(7)(A) provided that you:

1. Submit and/or cite all data required for registration of your product under FIFRA sec 3(c)(5) when the Agency requires all registrants of similar products to submit such data; and submit acceptable responses required for reregistration of your product under FIFRA section 4.

(continued on page 2)

Signature of Approving Official:

Richard 1. Gebken j Product Manager (10) Insecticide Branch, Registration Division (7505P) EPA Fonn 8570-6

Page 1 of6

Date:

January 14, 2011

, --Ll

(

2. Make the following change to the label:

a. Change the product registration number to "EPA Reg. No. 2382-185 b. Remove the following tube and respective weight ranges from the product label:

1. 1 tube count containing 2.68 ml for dog 2. 36 tube count containing 2.68ml for dog 3. 6 tube count containing 4.02ml for dog

Additional Child Resistant Packaging data is needed to approve these product sizes. c. Remove and or modify all label as follows

Page 2 of6

• Remove the subheading "PHYSICAL OR CHEMICAL HAZARDS" from all locations, since there is no text assoCiated with this subheading.

• Within the First Aid section for all locations, change "IF ON SKIN" to "IF ON SKIN OR CLOTHING"

• "Change the following statement in all locations from: "The control of sarcoptic mange infestations can be aided by the use of EFFIPRO'" FOR DOGS" to "Aids in control of sarcoptic mange infestations."

• Change "However, a monthly application is recommended" in all locations to "Apply monthly"

• Change the following statement in all locations from "For killing fleas, all stages of brown dog ticks, American dog ticks, lone star ticks, and deer ticks (including those tick vectors which may transmit Lyme disease and other tick borne diseases), mosquitoes and chewing lice; apply to DOGS or PUPPIES (8 weeks old or older) as follows:" by "removing the words "including those tick vectors" from the statement. The Agency acknowledges only the standard claim "Deer ticks that may transmit [carry] Lyme disease."

• Remove the following statement"[HOW TO APPLY(?)] " from all locations on the label.

• Change "pet's" and "pet" in all locations to "dog's" and "dog respectively. • Within the following sentence for all locations on the label: "Research has shown

that flea, tick and chewing lice infestations can be completely controlled with monthly applications ofEFFIPRO"' TOPICAL SOLUTION FOR DOGS." Remove the word "completely"

• Revise the following statement from all locations on the label: "However, a monthly application is recommended if' to "Apply monthly"

• Revise the following statement in all locations on the label from "monthly applications are recommended" to "apply monthly."

• In all locations on the label, other than the First Aid section, change the word "treatment" to "application" and "treat" to "apply"

• Remove the following text from all locations on the label "-Once monthly application" and "X applicators (tubes) X monthly doses (applications) (treatments)" The "X" in these statements is open ended, and is dictated by the CRP studies conducted for each product size and count.

• In all locations on the label, the "any" must be changed to all caps in the following statement "Individual sensitivities, while rare, may occur after using any pesticide product."

• In all locations, change the statement: Change "FOR USE ON DOGS AND PUPPIES 8 WEEKS OLD OR OLDER" to "FOR USE ONLY ON DOGS AND PUPPIES 8 WEEKS OLD OR OLDER"

1... -L /

(

• Revise the statement in all locations on the label from: "For animal use only" to For Use on Dogs only"

• The Signal Word "CAUTION" must be in all caps and bold in all locations. • Change "Wash thoroughly with soap and water after handling." Within the

Hazards to Humans section of the label (all locations) to "Wash hands thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco." All locations on the label.

d. Remove the following marketing claims or other conflicting claims:

Page 3 of6

.:

Virbac PARASITOLOGY

ANIMAL HEALTH

It is not consistent with the name at the bottom of the label for the company. In addition this product is not intended as an "ANIMAL HEALTH" or "PARISITOLOGY" product. • Stops existing infestations and prevents establishment of new infestations • Pest reinfestations prevented for a month or longer • Kills emerged young-adult fleas prior to egg-laying • Kills fleas that may transmit disease, including bartonellosis, tapeworm and

tularemia • Kills fleas that may cause flea allergy dermatitis (FAD) or anemia • Kills all stages of brown dog ticks, American dog ticks, lone star ticks, and

deer ticks (ticks that may transmit Lyme disease, Rocky Mountain Spoiled fever, babesiosis, ehrlichiosis, anaplasmosis and other tick borne diseases)

• Protects (your dog and puppy 8 weeks of age or older) from fleas for one month

• Protects from fleas for one month • Performance guaranteed or your money back (Please call our professional

staff at xxx-xxx-xxxx if you have any questions or comments about EFFIPRO TOPICAL SOLUTION FOR DOGS)

• Kills fleas that may transmit bartonellosis and tapeworm disease • Quick onset of activity • Persistent efficacy through 30 days • Prevents (re-) infestation for one month • Monthly treatment (all year) is recommended for control and prevention of

fleas • Fragrance (odor) free • No noticeable odors • Rapid kill of fleas is important in the prevention of disease transmission by

(these) parasites • Available from licensed veterinarians • Sold by veterinarians • Kills fleas that may transmit diseases, including bartonellosis, tapeworm and

tularemia

> --2/

•

• •

• •

• • • • • • •

• •

•

•

• •

• •

• • • • • • • •

( (

Acts to kill fleas that may transmit disease, such as bartonellosis, tapeworm and tularemia Regular (monthly) use breaks the flea life cycle Easy to use applicator makes treatment simple (trouble free, smooth) and comfortable for your pet 1

For indoor and outdoor dogs2

Provides ongoing protection against fleas and the diseases they may transmit for one month Protects your dog from flea infestation that may cause anemia Proven treatment (technology) for flea infestation Protects for one month Effective monthly treatment of fleas, ticks and mosquitoes Kills fleas, licks and mosquitoes for one month Picture of Dog (or Puppy) Kills the vectors that may transmit Lyme disease, Rocky Mountain Spotted fever, babesiosis, ehrlichiosis, bartonellosis, hepatozoonosis and heartworm disease Long lasting flea, tick and mosquito control for your pet Kills ticks including Deer ticks (vector of Lyme disease), American dog licks (vector of Rocky Mountain Spotted fever), Brown dog tick (vector of ehrlichiosis), Gulf Coast Iicks3 and Lone Star licks (vector of hepatozoonosis) for one month (4 weeks) (30 days) Kills Brown dog ticks (Rhipicephalus spp), American dog licks (Dermacenlor variabilis), Deerticks (Ixodes spp), Gulf Coast ticks4 (Amblyomma maculatum) and Lone Star ticks (Amblyomma americanum) for one month (4 weeks) (30 days) Kills Amblyomma americanum (Lone Star ticks) and Amblyomma

maculatum (Gulf Coast ticks)4 for 4 weeks (for one month) (for 30 days) Single application lasts 4 weeks (one month) (30 days) Kills fleas that may serve as an intermediate host for tapeworms (Dipylidium caninum) Stops existing flea infestations by rapidly killing adult fleas Illustration of flea life cycle 4

Illustration of tick life cycle 5

Illustration of mosquito life cycle 5

Illustration of mite life cycle5

Illustration of louse life cycle 5

Illustration of flea Illustration of tick5

Illustration of mosquit05

Illustration of mite 5

Illustration of louse 5

Illustration or photograph of dog or puppi

I This statement detracts and conflicts from the Hazards to Humans and Domestic Animal Section statements. 2 This is an indoor use product only, so any reference to "outdoor" must be removed. 3 The cited me-too product does not list the Gulf Coast Tick on the label. 4 All images must be presented to the Agency for approval before use.

Page 4 of6

( (

• Veterinary recommended

• Veterinarian recommended

2. Agency requirements with respect to the continued registration: a. The registration for this product is time-limited and expires two years from the date this

product is released for shipment bearing the revised language. You must provide the Agency with a projected release for shipment date within 30 days of the date of this letter. The Agency will calculate the expiration date based on the projected release date until an actual release date is provided in writing.

3. Reporting of incident data for this product:

Page 5 of6

a. You must submit quarterly enhanced incident reports and quarterly sales information in doses sold for this product for the quarter that begins on October 1, 2010. The quarterly reports are due two months after each quarter ends. . Please flag any Confidential Business Information as such. Enhanced incident reporting should be submitted to the Product Manager. Quarterly sales information should be submitted to the Registration Division, Immediate Office (attn: Kimberly Nesci The following is a list of information that must be .included in the quarterly reports for each incident: • EPA Registration Number • Product name (brand name) • Lot# • Where purchased: internet, store, veterinarian • Active Ingredient(s) • Weight range for product • Date on which incident occurred. (mm/dd/yyyy) • State in which the incident occurred. (standard 2 letter abbreviation) • Registrant case # • Species: dog, cat, other (specify) • Breed: (as reported by pet owner) • Age: months or years • Sex: M, F, or neutered • Weight: pounds • Primary Route of exposure: dermal, oral, other animal, inhalation, other • Body System: neurological, dermatological, GI, respiratory, ocular, other • Major signs noted with separate column for each sign, using standard terminology • Time to Onset: (hours, days) • Treated by veterinarian: yes or no • First time product used: yes or no • Misuse: use on incorrect species, overdose, too frequent dosing, other (describe) • Any known precondition • EPA Severity Code: death, major, moderate, minor • Outcome: died, recovered, still treated, unknown

b. Along with the enhanced incident reporting, you must submit an analysis of the incidents seen, to include the following details: • All incidents should be reported including all minor dermal and ocular irritation reports. • Summary table for dogs showing number of incidents of each severity code for each route of exposure. Each incident should only be reported once. If one incident has several routes of exposure, the order should be ocular> oral> dermal. In other words, an incident with both oral and dermal exposure would be reported as oral exposure, and an incident with both ocular and oral exposure would be reported as ocular exposure. • A similar summary table for dogs (misuse or secondary exposure) showing number of incidents of each severity code for each route of exposure.

S L/

c (

• Summary table for dogs and table for cats showing number of incidents that are believed due to secondary exposure (e.g., multi-pet households) .. • A summary table for dogs showing number of incidents for each severity code for these age ranges: <3 months, 3-6 months, 6-9 months, 9-12 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr, 6 yr, 7 yr, 8 yr, 9 yr, 10 yr, II yr, 12 yr, 13 yr, 14 yr, 15 yr, >15 yr. • A summary table showing the number of dog incidents for each severity code for each pet weight range on the product label (if applicable). • A summary table for dog weight showing number of incidents for each product weight range. This table should show number of incidents in dogs weighing less than that product weight range, number of incidents in dogs in lower half of weight range, number of incidents in dogs in upper half of weight range, and dogs weighing more than the product weight range (if applicable). • Table showing number of incidents for each dog breed. • Table showing number of incidents in dogs for each clinical sign. • Table showing number of incidents in dogs for each organ system. • Report aggregate incidents, but do not combine moderate and minor incidents.

4. Other Comments: . a. This product has met the requirements for Child Resistant Packaging (CRP) except for those

listed in 2(b) above, however, the Agency reserves the right to reevaluate the associated data if: 1. an incident report shows any problems in human, and/or 2. epidemiological evidence indicates a problem once the products reach the marketplace.

b. Consider limiting the formulations of each product to one basic confidential statement of formula, if applicable. The Agency may require this in the future. It is possible that no additional alternate formulations or minor formulation amendments will be approved for this product in the future.

c. If the Agency determines that future mitigation measures are necessary for all pet spot-on products, you will be informed, and be expected to comply. If mitigation measures are necessary, the Agency may take appropriate regulatory actions.

5. You must submit two copies of the revised final printed labels and (Master label and Production Copies) for all sizes for the Agency records, before the product is released for shipment.

Ifthese conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6(e). Your release for shipment of the product constitutes acceptance of these conditions. A stamped copy of the label is enclosed for your records. Submit one copy of the revised final printed label for the record before the product is released for shipment.

A stamped copy ofthe label is enclosed for your records.

Richard J. Gebken Product Manager (10) Insecticide Branch Registration Division (7505P)

Enclosure: Label stamped "Accepted with Comments" 2382-185 D433461

Page 6 of6

i

( (

{Pending Master Label} EFFIPRO® TOPICAL SOLUTION FOR DOGS FOR USE ONLY ON DOGS AND PUPPIES 8 WEEKS OLD OR OLDER For convenient, quick-acting, long-Iasling, effective conlrol of fleas, ticks, mosquitoes and chewing lice EFFIPROli> TOPICAL SOLUTION FOR DOGS contains the active ingredient Iipronil. which controls infestations caused by fleas. ticks. mosquitoes and chewing lice on dogs weighing 2310 44.9Ibs. weighing 45to 88.9Ibs. weighing 89 to 132Ibs).

ACTIVE tNGREDIENT: Fipronit ...................... " ........................................................................... .. .. ............. 9.6% OTHER INGREDIENTS; ................................................ .................. .. .. .................................... 90.4% TOTAL: ................... """"""""""'" ....................................................................... .. . ..................................... 100.0%

HAZARDS TO HUMANS

KEEP OUT OF REACH OF CHILDREN

CAUTION READ ENTIRE LABEL BEFORE EACH USE

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS

CAUTION ;

Harmfvl if swallowed. Causes eye irritation. Avoid contact wilh skin. eyes. or Clothing. Wash thoroughty with soap and water alter handfing.

HAZARDS TO DOMESTIC ANIMALS

For external use only. 00 not use on puppies under 8 weeks of age. Individual sensilivities. while rare, may occur after using any pesticide product. Possible temporary irritation may occur at the site where EFFIPROS TOPICAL SOLUTiON FOR DOGS was applied. Contact a veterinarian immediatety if signs become parsislenl or become more severe during the first few days fOllowing application. It an unusual reaction is observed following initiat application. a veterinarian shoutd be consulted before repealing treatment. Certain medications can interact. with pesticides. Consult a veterinarian before using on medicated. debilitated or aged animals.

1 IF SWALLOWED: 1·

i • , I

i • IF IN EYES: !

,

FIRST AID

Call a poison control cenler or doctor immediately for treatment advice.

Have person sip a glass of waler if able to swallow.

Do not induce vomiting unless told to do so by a poison control center or doctor.

00 not give anything by mouth to an unconscious person.

Hold eye open and rinse slowly and gently with water for 15-20 minutes.

~ __________________ -rI~. __ ~c~a~lI~a~,p~(O~iS~O~n~c~o~nl~ro~l~c~e~nt~e~r~or~d~o~c~t~~~~r~lr~e~at~m~e~n~ta~~~ic~e~. ______________________ ___

I' Remove contact lenses. if present, after the first 5 minules. then continue rinSing eye. i' 1. Take off conlaminated clothing. i IF ON SKIN:

i :. Rinse skin immediately wilh plenty of water for 15-20 minutes. 1

i' Call a ooison control cenler or doctor for Irealment advice. Have product container or labet with youwhen calling a poison conlrol cenler or doclor, or going for treatment.

You may also contact the Hotline number 1-800·338-3659 for health concerns, emergency medical treatment

information or pesticide incidents.

DIRECTIONS FOR USE It is a violation of Federal law to use this product in any manner inconsistent with its labeling. Do nol allow children to apply product. TO PREVENT HARM TO YOU AND YOUR PET. READ ENTIRE LABEL AND DIRECTIONS BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS.

For killing fleas. all stages of brown dog ticks, American dog ".cks. lone star t~cks. and deer Ucks (iRGh;lQiR9 U'IQ69 liGk ..eeIefS which may transmit Lyme disease and olher tick borne diseases). mosqUItoes and cheWing lice; apply to DOGS or PUPPIES (8 weeks old or older) as follows:

EP,\ Reg. No. 2382-RIL page J of 15

1 ---z.J

c

APPLICATION DIREC'TIONS

1. Remove one applicator from packaging. Hold applicator upright and remove cap.

2. Invert cap and place other end back onto applicator tip. Push cap down to break seal. Remove cap prior to treatment application.

3. Part ~hair between shoulder blades until skin is visible. Place applicator lip direclly against exposed skin. Deposit entire contents by squeezing the applicator at a Single site on ~skin. Ensure that EFFIPRO® FOR DOGS is not applied superficially on ~hair.

°Kr,~' ._ ... -_ . ...

1--·

\.., ~'.:. -':Nr'< .' ',''.:~';, ':" )

(

EFFIPRO® TOPICAL SOLUTION FOR DOGS is also approved for control of flea, tick, mosquito and chewing lice infestations in breeding, pregnant and lactating bitches. The control of sarcoptic mange infestations can be aided by the use of EFFIPRO® FOR DOGS. Elimination of miies may require multiple monthly treatments.

FREQUENCY OF APPLICATION Research has shown that flea, tick and chewing lice infestations can be eeffij3lelely controlled with monthly applications of EFFIPRO® TOPICAL SOLUTION FOR DOGS. .

Fleas: EFFIPRO® FOR DOGS can kill adult fleas for up to three months. Ilawe."er. a ffieAI"ly 8j3j3liealieA is reeeffiffieAde~if your ~as fleas that may cause flea allergy dermatitis (FAD). or if reinfestation is likely. Ticks: EFFIPRO® FOR DOGS can kill ticks for a month or longer. However. where tick control is consistently needed, mentftIy 8j3llliealieAs are reesffiffieAde~ Chewing Lice: EFFIPRO® FOR DOGS can kill chewing lice for a month or longer. However, where chewing lice control is consistently needed. FASAtRty aj3j3lieetisAS are reeSFAffieAde!l Mosquitoes: When applied monthly, EFFIPRO® FOR DOGS can kill mosquitoes within 24 hours (for up to 7 days} and within 48 hours (for up to 28 days}. Notes: Wait at least 30 days before re-application of EFFIPRO" FOR DOGS. AVOid contact with treated area until dry.

EFFIPRO<!l FOR DOGS is effective after bathing. shampooing, water immersion. or sunlight exposure.

STORAGE AND DISPOSAL

Do not contaminate water, food, or feed by storage and disposal.

STORAGE: Store unused product in original container only. out of reach of children and animals. PESTICIDE ICONTAINER DISPOSAL: If empty: Nonrefillable. Do not reuse or refill this container. Offer for recyCling, if available. If partially filled: Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. .

LIMITED WARRANTY AND DISCLAIMER

To the extent conSistent with applicable law. buyer assumes all risks of use, storage. or handling of this product not in accordance with directions. Buyer and user assume all risk of use and handling of this material when such use and handling are contrary to label instructions. To the extent consistent with applicable law, any damage arising from a breach of this warranty shall be limited to direct damages and shall not inclyde consequential commercial damages such as loss of profit or values.

Net Contents 1. 6 or 36 single-dose applicator(s) per package. Each applicator contains 1.34 mL

Net Contents 6 single-dose applicators per package. Each applicator contains 2.68 mL Net Contents 1 or 36 single-dose applicator(s) per package. Each applicator contains 4.02 mL

EPA Reg. No. 2382-XXX

EPA Est. No. 2382-FRA-1

VIRBAC AH, INC. PO BOX 162059 FORT WORTH TX 76161 1-800-338-3659

Made In France

EPA Reg. No. 2382-RIL page 2 of 15

(

EFFIPRO® is a registered Irademark of Virbac. Questions or comments? Call: 1-800-338-3659

(

EFFIPRO®TOPICAL SOLUTION FOR DOGS FOR USE ONLY ON DOGS AND PUPPIES 8 WEEKS OLD OR OLDER For convenient, qulck-acting,long-lastlng, effective control of fleas, ticks, mosquitoes and chewing lice.

Easy and convenient application (applications)

Kills mosquitoes Chewing lice infestations are rapidly eliminated Can be used on breeding, pregnant and lactating bitches

EFFIPRO@TOPICAL SOLUTION FOR DOGS contains the active ingredient fipronil. which controls infestations caused by fleas, ticks, mosquitoes, and chewing lice on dogs (weighing 23 to 44.9Ibs. weighing 45 to 88.9 Ibs, weighing 89 to 132Ibs).

EFFIPRO@TOPICAL SOLUTION FOR DOGS contains the active ingredient fipronil, which controls infestations caused by fleas, ticks, mosquitoes, and chewing lice.

Open resealable label for directions & precautions

See back panel for additional precautionary statements.

See enclosed Inserts for directions for use.

See package insert for frequency of application.

Lot No.:

(Detachable) calendar (monthly application) reminder stickers (with illustration of dog or puppy).

ADDITIONAL MARKETING TEXT

h da s

Mo ear is recommended for control and revention of flea Once monthly application (Kapplicalors (lubes» (KmOfilhly aoses (applications) (treatments) Quick drying, non-greasy Easy to apply spot-on (topical) application Convenient, easy to apply


J l/

(

bartonellosis ta worm and tularemi

worm and tularemi

Treatment of dogs wilh EFFIPR OPICAl SOLUTION FOR DOGS kills fleas that may cause flea allergy dermalitis (FAD) May be used on puppies from 8 weeks of age Proven treatment technology for nea infestation (Easy 10 use applicator makes treatment simple (trouble free. smooth) and comfortable for your eetj) (F~rilidQ(jfana ouldoot dogs) EFFIPRO® TOPICAL SOLUTION FOR DOGS kills fleas on your dog Kills adult fleas which may cause Flea Allergy Dermatitis (FAD) (Provides ongoing protection against fleas and the diseases they may transmit for one month) Kills fleas which may cause anemia Fleas do not have to bite to die Kills fleas that may cause anemia tProtectsyourdoa from flea infestation that may cause anemiill Remains effective after

Remains effective after bathing and swimming Monthly treatment is recommended for control and prevention of neas, ticks and mosquitoes Remains effective even after bathing, water immersion or exposure to rain or sunlight Remains effective even after bathing Remains effective after exposure to rain and sunlight Still works after bathing, swimming or exposure to sunlight Convenient topical treatment for dogs who enjoy the outdoors

outdoors

Kills Amblyomma americanum (Lone Star ticks)[and Amblyomma macula/um (Gulf Coast ticks»for 4 weeks (for one month) (for 30 days) Maintains residual efficacy after bathing and <:Wlmmllnn

u

Kills mosquitoes for up 10 28 day

EPA Reg. No. 2382-RIL page 4 or 15

( (

{Product Claims to be printed on package insert or booklet outsert}

EFFIPRO®TOPICAL SOLUTION FOR DOGS FOR USE ONLY ON DOGS AND PUPPIES 8 WEEKS OLD OR OLDER For convenient, quick-acting, long-lasting, effective control of fleas, ticks, mosquitoes and chewing lice.

Easy and convenient application (applications) S d ev new Infestations

es (e eslal ev ad a· or 10 er Waterproof (remains effective after bathing and swimming) (Killumerged young-adult fleas. DrioFtoegg-lavinQJ (Kills ft~ that may transmit disease; .Including bartonellosis, tapeworm and tularemia) Kills fleas that may cause flea allergy dermatitis (FAD) or anemia

. R~~~'f!~-;S~~~~f§~~{¢~~~~ad~:~~(l!~kJ ~r~6~ :~n~mi Kills mosquitoes Chewing lice infestations are rapidly eliminated Can be used on breeding, pregnant and lactating bitches

EFFIPRO® TOPICAL SOLUTION FOR DOGS contains the active ingredient tipronil, which controls infestations caused by fleas. ticks, mosquitoes. and chewing lice on dogs (weighing 23 to 44.9 Ibs, weighing 45 to 88.91bs, weighing 89 to 132 Ibs).

EFFIPROE> TOPICAL SOLUTION FOR DOGS contains the active ingredient tipronit, which controls infesiations caused by fleas, ticks. mosquitoes, and chewing lice.

ACTIVE INGREDIENT: Fipronil .................................................................................................................................................................. ..

OTHER INGREDIENTS: .......................................................................................................................... .

TOTAL: ................................................................................................................................................. .

HAZARDS TO HUMANS





CAUTION

. ....... 9.6%

.. ............ 90.4%

.. 100.0%

Harmful if swallowed. Causes eye irritation. AVOid contact with skin, eyes, or clothing. VVash thoroughly with soap and water after handling.


For external use only. Do not use on puppies under 8 weeks of age. Individual sensitivities. while rare, may occur after using flfIVesticide product. Possible temporary irritation may occur at the site where EFFIPRO® TOPICAL SOLUTION FOR DOGS was applied. Contact a veterinarian immediately if signs become perSistent or become more severe during the first few days following application. If an unusual reaction is observed following initial application, a veterinarian should be consulted before repeating treatment. Certain medications can interact with pesticides. Consult a veterinarian before using on medicated, debilitated or aged animals.


(

(PHYSICAL OR CHEMICAL HAZARDS)

FIRST AID

IF SWALLOWED: · Call a poison control center or doctor immediately for treatment advice.

· Have person sip a glass of water if able to swallow.

· Do not induce vomiting unless told to do so by a poison control center or doctor.

· Do not Clive anythinC) by mouth to an unconscious p~rson.

IF IN EYES: · Hold eye open and rinse slowly and gently with water for 15-20 minutes.

· Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.

· Call a poison conlrol center or doctor for treatment advice.

IF ON SKIN.i. · Take off contaminated clothing.

· Rinse skin immediately with plenty of water for 15-20 minutes.

• Call a Q.oison control center or doctor for treatment advice. Have product container or Jabel with you when calling a poison control center or doctor, or going for treatment.

You may also contact the Hotline number 1-800-338-3659 for health concerns, emergency medical treatment


DIRECTIONS FOR USE 1\ is a violation of Federal law to use this product in any manner inconSistent with its labeling. Do not allow children to apply product. TO PREVENT HARM TO YOU AND YOUR PET, READ ENTIRE LABEL AND DIRECTIONS BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS.

For killing neas, all stages of brown dog ticks, American dog ticks, lone star ticks, and deer ticksUincluding those tick) (\/eclorswhichlmay transmit Lyme disease and other tick borne diseases), mosquitoes and chewing lice; apply to DOGS or PUPPIES (8 weeks old or older) as follows:

APPLICATION DIRECTIONSrrHOW TO APPLY(?)j)

1. Remove one applicator from packaging. Hold applicator upright and remove cap.

2. Invert cap and place other end back onto applicator tip. Push cap down to break seal. Remove cap prior to treatment application.

3 Part ~hair between shoulder blades until skin is viSible. Place applicator tip directly against exposed skin. Deposit entire contents by squeezing the applicator at a single site on pet's skin. Ensure that EFFIPR08 FOR DOGS is not applied superficially on pet's hair.

EFFIPROE> TOPICAL SOLUTION FOR DOGS is also approved for control of flea, tiCk, mosquito and chewing lice infestations in breeding, pregnant and lactating bitches. The control of sarcoptic mange infestations can be aided by the use of EFFIPR08

FOR DOGS. Elimination of mites may require multiple monthly treatments.

FREQUENCY OF APPLICATION

Research has shown that flea, tick and chewing lice infestations can be e9A'lllletely controlled with monthly applications of EFFIPROII> TOPICAL SOLUTION FOR DOGS.


lL ~

1 I

----------------

( (

Fleas: EFFIPRO® FOR DOGS can kill adult neas for up to three months. He'Ne· .. er, a FReAIAly a~~liealiaA is FeeeFRFReAEle§...if your""Pe!.has fleas that may cause nea allergy dermatitis (FAD), or if reinfestallon is likely. Ticks: EFFIPRO® FOR DOGS can kill ticks for a month or longer. However, where tick control is consistently needed, F!I&ffiRIy a~~lieatieAs aFe reeeFRFReAEleE!1. Chewing Lice: EFFIPRO® FOR DOGS can kill chewing lice for a month or longer. However, where chewing lice control is consistently needed, meAIAly aJ3pliealieAs aFe FeeBFRFReAEle!i Mosquitoes: When applied monlhly, EFFIPR019 FOR DOGS can kill mosquitoes within 24 hours (for up to 7 days) and within 48 hours (for up to 28 days). Notes: Wait at least 30 days before re-application of EFFIPRO® FOR DOGS. Avoid contact with treated area until dry.

EFFIPRO® FOR DOGS is effective after bathing, shampooing, water immersion, or sunlight exposure.


Do not contaminate water, food, or feed by storage and disposal.

STORAGE: Store unused product in original container only, out of reach of children and animals.

PESTICIDE ICONTAINER DISPOSAL: If empty: Nonrefillable. Do not reuse or refill this container. Offer for recycling, if available. If partially filled: Call your local solid waste agency for disposal insiructions. Never place unused product down any indoor or outdoor drain.


To the extent consistent with applicable law, buyer'assumes all risks of use, storage, or handling of this product not in accordance with directions. Buyer and user assume all risk of use and handling of this material when such use and handling are contrary to label instructions. To the extent consistent with applicable law, any damage arising from a breach of this warranty shall be limited 10 direct damages and shall not include consequential commercial damages such as loss of profit or values.

How supplied: For easy and convenient treatment, EFFIPRO® TOPICAL SOLUTION FOR DOGS is available in sizes for dogs and puppies 8 weeks and older and up 23-44.9Ibs,large dogs 4S-88.9Ibs, and extra large dogs 89-132Ibs. Net Contents 1, 60r 36 single-dose applicator(s) per package. Each applicator contains 1.34 mL

Net Contents 6 single-dose applicators per package. Each applicator contains 2.68 mL Net Contents 1 or 36 single-dose appllcator(s) per package. Each applicator contains 4.02 mL

Open resealable label for directions & precautions

(Detachable) calendar (monthly application) reminder stickers (with illustration of dog or puppy).

EPA Reg. No. 2382·XXX EPA Est. No. 2382-FRA-1

VtRBAC AH, INC. PO BOX 162059 FORT WORTH TX 76161 1-800-338-3659

Made in France EFFIPRO® is a registered trademark of Virbac.

{Product Claims to be printed on outer package or other places}

Kills mosquitoes Chewing tice infestations are rapidly eliminated Can be used on breeding, pregnant and lactating bitches

EFFIPRO® TOPICAL SOLUTION FOR DOGS contains the active ingredient fipronil, which controls infestations caused by fleas, ticks, mosquitoes, and chewing lice.

Questions or comments? Call: 1-800-338-3659

EPA Reg. No. 2382-RIt. page 7 of 15

( (

{Text for Front Panel of Outer Package (box)}

TOPICAL SOLUTION FOR DOGS Kills fleas, ticks, mosquitoes and chewing lice

For convenient, quick-acting, long-lasting, effective control of fleas, ticks, mosquitoes and chewing lice

• Waterproof

Fer Degs aREI Pl-:l~~ies 8 '.veel(s aiel 9F elele~ (Weighing 23 to 44.9 Ibs, weighing 45 to 88.9 Ibs, weighing 89 to 132 Ibs)

ACTIVE INGREDIENT: Fipronil ........................................................................................................................................................................................... 9.6%

OTHER INGREDIENTS: ............................................................................................................................................................ 90.4%

TOTAL: .................................................................................................................................................................................... 100.0%

KEEP OUT OF REACH OF CHILDREN CAUTION

Lift here to open

See back panel for additional precautionary statements.

See enclosed Inserts for directions for use.

1,6 or 36 single-dose applicator(s) per package. Each applicator contains 1.34 mL

6 single-dose applicators per package. Each applicator contains 2.68 mL

1 or 36 single-dose applicator(s) per package. Each applicator contains 4.02 mL

Fer 8Rimall:lse 8Rly Batch No.

{Text for Front Panel of Outer Package (box) after opening}

® . E F F I PRO TOPICAL SOLUTION FOR DOGS

DIRECTIONS FOR USE It is a violalion 01 Federal law to use Ihis product in any manner inconsistent wilh ils labeling. Do nol allow children to apply product. TO PREVENT HARM TO YOU AND YOUR~READ ENTIRE LABEL AND DIRECTIONS BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY USE ON DOGS ONLY DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS.

EPA Reg. No. 2382·RIL page 8 of 15

( (

For killing fleas, all slages of brown dog licks, American dog tleks, lone star licks, and deer licks (including those tick veClors which may Iransmit Lyme disease and olher lick borne diseases), mosquitoes and chewing lice; apply 10 DOGS or PUPPIES (8 weeks old or older) as follows:

AP PLICATION DIRECTIONSO'llImwJ!l@Jt,,'IJ

1.

2.

3.

Remove one applicator from packaging. Hold applicator upright and remove cap. Invert cap and place other end back onto applicator lip. Push cap down to break seal. Remove cap prior to treatment application. Part ~hair between shoulder blades until skin is visible. Place applicator tip directly against exposed skin. Deposit entire contents by squeezing the applicator at a single site on ~skin. Ensure that EFFIPRO<9 FOR DOGS is not applied superficially on ~hair.


To the extent consistent with applicable law, buyer assumes all risks of use. storage, or handling of this product not in accordance with directions. Buyer and user assume all risk of use and handling of this material when such use and handling are contrary to label instructions. To the extent consistent with applicable law, any damage arising from a breach of this warranty shall be limited to direct damages and shall not include consequential commercial damages such as loss of profit or values.

{Text for Back Panel of Outer Package (box)}

EFFIPR08 TOPICAL SOLUTION FOR DOGS

FOR USE ONLY ON DOGS AND PUPPIES 8 WEEKS OLD OR OLDER

FOR USE ONLY ON DOGS AND PUPPIES 8 WEEKS OLD OR OLDER (WEIGHING 23 TO 44.9 LBS, WEIGHING 45 TO 88.9 LBS, WEIGHING 89 TO 1321bs),

For convenient, quick-acting, long-lasting, effective control of fleas, licks, mosquitoes and chewing lice

For convenient, quick-acting, tong-tasting, effective control of fleas, ticks, mosquitoes and chewing lice for DOGS and PUPPIES 8 weeks old or older (weighing 23 to 44.9 Ibs, weighing 45 to 88.9 Ibs, weighing 89 to 132 Ibs).

EFFIPRO!l TOPICAL SOLUTION FOR DOGS contains the active ingredient fipronil, which controls infestations caused by fleas, ticks, mOSQuitoes, and chewing lice on dogs 8 weeks old or older (weighing 23 to 44.9 Ibs, weighing 45 to 88.9Ibs. weighing 89 to 132Ibs).

ACTIVE INGREDIENT: Fipronil .............................. . .. .................. 9.6%

OTHER INGREDIENTS: .... . ... 90.4%

TOTAL: ................................ . .. ............. 100.0%

EPA Reg. No. 2382·RIL page 9 M I ~



(



CAUTION

HAZARDS TO HUMANS

Harmful if swallowed. Causes eye irritation. Avoid contact with skin, eyes, or clothing. Wash thoroughly with soap and water after handling.


For external use only. Do not use on puppies under 6 weeks of age. Individual sensitivities, while rare, may occur after using any pesticide product. Possible temporary irritation may occur at the site where EFFIPROi!> TOPICAL SOLUTION FOR DOGS was applied. Contact a veterinarian immediately if signs become persistent or become more severe during the first few days following application. If an unusual reaction is observed following initial application, a veterinarian should be consulted before repeating treatment. Certain medications can interact with pesticides. Consult a veterinarian before using on medicated, debilitated or aged animals.

PHYSICAL OR CHEMICAL HAZARDS

FIRST AID

IF SWALLOWED: · Call a poison control center or doctor immediately for treatment advice.

· Have person sip a glass of water if able to swallow.

· Do not induce vomiting unless lold to do so by a poison control center or doclor.

· Do not give anything by mouth to an unconscious person.

tFIN EYES: · Hold eye 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 eye.

· Call a ~oison control center or doctor for treatment advice.

IF ON SKIN:.l... · Take off contaminated clothing.

· Rinse skin immediately with plenty of water for 15-20 minutes.

• Cali a poison control center or doctor for treatment advice. Have product container or label with you when calling a poison control center or doctor, or going for treatment.

You may also contact the Hotline number 1-800-338-3659 for health concerns, emergency medical treatment


DIRECTIONS FOR USE It is a violation of Federal law to use this product in any manner inconsistent with its labeling. Do not allow children to apply product. TO PREVENT HARM TO YOU AND YOUR PET. READ ENTIRE LABEL AND DIRECTIONS BEFORE EACH USE. FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER ANIMALS.

For killing fleas, all stages of brown dog ticks, American dog ticks, lone star ticks. and deer ticks (including those tick vectors which may transmit Lyme disease and other tick borne diseases), mosquitoes and chewing lice; apply to DOGS or PUPPIES (6 weeks old or older) as follows:

APPLICATION DIRECTIONS([HOW TO APPLY(?)D 1. Remove one applicator from packaging.

Hold applicator upright and remove cap. 2. Invert cap and place other end back onto applicator tip.

Push cap down to break seal. Remove cap prior to treatment application.

3. Part ~hair between shoulder blades unlil skin is visible. Place applicator tip directly against exposed skin. Deposit entire contents by squeezing the applicator at a Single site on ~skin. Ensure that EFFIPROI!> FOR DOGS is not applied superficially on ~hair.

EPA Reg. No. 2382·RII p~gc IOof 15

) b -Ll

( (

. li I

EFFIPRO® TOPICAL SOLUTION FOR DOGS is also approved for control of flea. lick. mosquito and chewing lice infestations in breeding. pregnant and lactating bitches. The e9Rtrei sf saFe91llie FAaRge infestati9Rs ean ee aiEleEllly IAe ",se of EFFIPRO® FOR [lOG§.,. Elimination of mites may require multiple monthly treatments.

FREQUENCY OF APPLICATION

Research has shown that flea. tick and chewing lice infestations can be completely controlled with monthly applications of EFFIPR06 TOPICAL SOLUTION FOR DOGS.

Fleas: EFFIPRO® FOR DOGS can kill adult fleas for up to three months. Ho' .... e/eF. a FAonthly alll'llieation is FeeOFAFAeREleEilif your pet has fleas that may cause flea allergy dermatitis (FAD). or if reinfestation is likely. Ticks: EFFIPRO® FOR DOGS can kill ticks for a month or longer. However. Where tick control is consistently needed. ffi6fIiI:IIy aflflfiea~oRs are FeG9FAFAeRElei:li Chewing Uce: EFFIPROE> FOR DOGS can kill chewing lice for a month or longer. However. where chewing lice control is consistently needed. FA9Athly allllliealioAs are Fee9FAFAeAEle!t Mosquitoes: When applied monthly. EFFIPROs FOR DOGS can kill mosquitoes within 24 hours (for up to 7 days) and within 48 hours (for up to 28 days). Notes: Wail at least 30 days before re-application of EFFIPRO$ FOR DOGS. Avoid conlact with trealed area until dry.

EFFIPROE> FOR DOGS is effective after bathing. shampooing. water immersion. or sunlight exposure.


Do not contaminale water. food. or feed by storage and disposal.

STORAGE: Store unused product in original container only. oul of reach of children and animals.

PESTICIDE ICONTAINER DISPOSAL: If empty: Nonrefillable. Do not reuse or refill this container. Offer for recycling. if available. If partially filled: Call your local solid wasle agency for disposal instructions. Never place unused product down any indoor or outdoor drain.

See package insert for frequency of application.

VIRBAC AH, INC. PO BOX 162059 FORT WORTH TX 76161 1-800-338-3659

Made In France EFFIPRO" is a registered trademark of Virbac.

EPA Reg. No. 2382·XXX

EPA Est. No. 2382-FRA-1

EPA Reg. N". ~.1S2-RIL page II or 15

{ 7 ~

1;

( (

{Text for Left Side Panel of Outer Package (box)}

EFFIPR08 TOPICAL SOLUTION FOR DOGS For dogs and puppies 8 weeks old or older (weighing 23 to 44.9Ibs, weighing 45 to 88.9Ibs, weighing 89 to 132Ibs).

1, 6 or 36 single-dose applicator(s) per package. Each applicator contains 1.34 mL 6 single-dose applicators per package. Each applicator contains 2.68 mL 1 or 36 single-dose applicator(s} per package. Each applicator contains 4.02 mL

IIIl:IstratioR OF f'li:lotograf'li:l of Elog OF f'l1:lf'l~Y

Lot No.:() ..

{Text for Right Side Panel of Outer Package (box)}

EFFIPRO® TOPICAL SOLUTION FOR DOGS For dogs and puppies 8 weeks otd or older (weighing 23 to 44.91bs, weighing 45 to 88.91bs, weighing 89 to 132 IbS).

1, 6 or 36 single-dose applicator(s) per package. Each applicator contains 1.34 mL 6 single-dose applicators per package. Each applicator contains 2.68 mL 1 or 36 single-dose applicator(s) per package. Each applicator contains 4.02 mL

IIIl:IstratioR OF f'li:lotogn!f'lA of Elog or f'l1:lf'lf'lY

Lot No.::.

{Text for Top Panel of Outer Package (box)}

EFFIPRO~ TOPICAL SOLUTION FOR DOGS For dogs and puppies 8 weeks old or older (weighing 23 to 44.91bs, weighing 45to 88.9Ibs, weighing 89 to 132Ibs).

1,6 or 36 single-dose applicator(s) per package. Each appticator contains 1.34 mL 6 single-dose applicators per package. Each applicator contains 2.68 mL 1 or 36 single-dose applicator(s) per package. Each applicator contains 4.02 mL

LOI No.:

EP.\ Reg. No. 2382-RIl. page 12 of 15

( ~ --LI

( (

{Text for Bottom Panel of Outer Package (box)}

EFFIPROS TOPICAL SOLUTION FOR DOGS For dogs and puppies 8 weeks old or older (weighing 23 to 44.9 Ibs, weighing 45 to 88.9Ibs, weighing 89 to 132 Ibs).

1,6 or 36 single-dose applicator(s) per package. Each applicator contains 1.34 mL 6 single-dose applicators per package. Each applicator contains 2.68 mL 1 or 36 single-dose applicator(s) per package. Each applicator contains 4.02 mL

Lot No ..

{Text for Foil of Blister package}

Virbac EFFIPRO"Topical Solution Only for use (on dogs 23-44.9 Ibs. on dogs 45-88.9Ibs. on dogs 89-1321bs) (1.34 mL 2.68 mL, 4.02 mL) Contains fipronil (9.6%) Keep out of reach of children See full label for additional directions CAUTION EPA Reg. No.

{Text for Applicator Tube}

Virbac EFFIPRO" Topical Solution Only for use (on dogs 23-44.9Ibs. on dogs 45-88.9Ibs. on dogs 89-132 Ibs) (1.34 mL 2.68 mL. 4.02 mL) Contains fipronil (9.6%) Keep out of reach of children See full label for additional directions CAlJTIO~1 EPA Reg. No. Lot.:

{Additional Marketing Text for Placement on Outer Package, Package Insert or Booklet Outsert}

For dogs and puppies 8 weeks of age or older Effective monthly treatment against fleas Effective monthly control of fleas Protects (your dog and puppy 8 weeks of age or older) from fleas for one month Protects from fleas for one month Easy. spot on (topical) application

m ce u ran or our mo e back Please call our ro essional sta u r c mmen s about EF I 0 I L S N-

Kills fleas that may cause flea allergy dermatitis (FAD) and anemia (Kills fleas that may transmit bartonellosis arid tapeworm disease) Kills adult fleas for one month Convenient topical treatment for dogs (Quick onset of activitV)

EPA Reg. No. 2382·RIL page 13 of 15

l~ ---l)

..

(

(PersiStenlefficacy through 30 days) lRmarits;'fi~iiifestatfori for one moothl [MoltlnFVlfii!ifjeni'laR year) is recommended for conlrol and prevention of fleaS) Once monthly application ()( applicaiQlj (tubes» rxrTiOtltbly doSes/applications) (treatments» Quick drying, non-greasy Easy to apply spot-on (topical) application

~~~~~~~to~apPlY

(KI/f$ ftea$lhafma\j'transmit diseases. including bartonellOSiS. tapeworm and tularemiaJ Kills fleas Easy to apply, effective control of Heas that lasts 1 month

(

Acts to kill fleas thai may transmit disease, such as bartonellosis, tapeworm and tularemia Regular (monthly) use breaks the flea life cycle Treatment of dogs with EFFIPRO$ TOPICAL SOLUTION FOR DOGS kills fleas that may cause.flea allergy dermatitis (FAD) May be used on puppies from 8 weeks of age (Provllntreatment lechnology for flea infestatioril

a .. . rna as treatment slm ·'e trouble free smooth rd· s

TOPICAL SOLUTION FOR DOGS kills neas on your dog Kills adult fleas which may cause Flea Allergy Dermatitis (FAD) [Provides ongoing protection against fleas and the diseases they may transmit for one month) Kills fleas which may cause anemia Fleas do not have to bite to die Kills fleas that may cause anemia Protects your dog from flea infestation that may cause anemia Remains effective after

eatmen tecI'I

Remains effective after bathing and swimming . (Monthly treatment is recommended for control and prevention of fleas. ticks and mosquitoes) Remains effective even after bathing, water immersion or exposure to rain or sunlight Remains effective even after bathing Remains effective after exposure to rain and sunlight Slill works after bathing, swimming or exposure to sunlight Convenient topical treatment for dogs who enjoy the outdoors Formulated for dogs that love the outdoors For dogs that enjoy the outdoors

ansmi.\ L e d'sease Rock as s an artwo Isease

The successive feeding activity of Heas on dogs may elicit a hypersensitivity skin disorder known as flea allergy dermatitis (FAD) Treatment of with EFFIPRO« TOPICAL SOLUTION FOR DOGS rapidly kills fleas that may cause FAD (flea

EPA Reg. No. 2382-RIL page 14 or J 5

JY 1 )

, .'

Effipro8 Topical Solution for Dogs PENDING MASTER label amended November 18. 2010

EPA Reg. No. 2382·RIL page 15 of IS

Documents

I) ltt L J I -- Ll · I) /-ltt -L f) J I u.s. ... Illustration of louse life cycle 5 ... • Summary table for dogs showing number of incidents of each severity code for each route