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U.S. ENVIRONMENTAL PROTECTION AGENCY

Office of Pesticide Programs

Registration Division (7S0SC)

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460

NOTICE OF PESTICIDE: ..x Registration _ Reregistration

(under FIFRA, as amended)

Name and Address of Registrant (include ZIP Code):

Fort Dodge Animal Health PO Box 5366 Princeton, iu 08543-5366

EPA Reg. Number: Date ofIssuance:

80490-4 SEP 292008

Term of Issuance:

Conditional

Name of Pesticide Product:

ProMeris® Canine Flea Control

Note: Changes in labeling differing in substance from that accepted in connection witb this registration must be submitted to and accepted by t~e

Registration Division prior to use of tbe label in commerce. In any correSpondence on this product always refer to tbe above EPA registration number.

On the basis of information furnished by tbe registrant, tbe above named pesticide is hereby registered/reregistered under tbe 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 healtb and tbe

environment, tbe Administrator, on his motion, may at any time suspend or cancel the registration of a pesticide in accordance witb tbe Act. The acceptance

of any name in connection witb tbe 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/reregistration of your product when the Agency requires all registrants of similar products to submit such data.

2. The data requirements for storage stability and corrosion characteristics (Guidelines 830.6317 and 830.6320) are not satisfied. A one year study is required to satisfy these data requirements. You have 18 months from the date of registration to provide these data.

Continued on page 2

--SJgru!.ture of Approving Official: "... ... \ /"\ /tt . . "'~"'/~ ~hn !lebert, Product Manager Ins~icide-Rodenticide Branch, Registration Division (7505P)

Date:

SEP 292008

~ Form 8570-6

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Page 2 EPA Reg. No. 80490-4

3. Make the following label changes before you release the product for shipment:

a. Revise the EPA Registration Number to read, "EPA Reg. No. 80490-4." (Note: The file symbol should not be changed prior to registration.)

4. Submit one copy of the revised final printed label for the record before you release the.product . for shipment.

~. NOTE: For future submissions, make the following changes to your Confidential Statement of Formulation (Item 4 of EP A Form 8570-4):

a. Revise the EPA Reg. No. so it reads, "EPA Reg. No. 80490-4"

>If these 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. If you h~ve any questions, please contact Julie Chao at 703-308-8735 or chao.julie@epa.gov.

Enclosure

John Hebert Insecticide-Rodenticide Branch Registration Division (7505P)

ACCEPTED With COMMENTS

In EPA Letter Dated: SEP 292008

Under the Federal Insecticide, Fungicide and Rodenticide Act, As amended, for the pesticide Registered under EPA Reg. No:

S04-4o-Lt

PrOMeris· Canine Flea Control

Fort Dodge Animal Health A divi sian of Wyeth

t!IIJ/IJJ Pft)f\1eris· Canine Flea Control

Fort Dodge Animal Health A cWisiJn;fWywth

Single spot application for control of fie .. on d~gs and puppies B weeks of age and older.

ACTIVE INGREDIENT: Metaflumizane (CAS No. 139968-49-31 ...... .................................... . ...... .14.48%

OTHER INGREDIENTS ............. "....... ............................................................... . ... " ... 85.52% TOTAl. .............................................................. 100.00%

KEEP OUT OF REACH OF CHILDREN CAUTION

READ ENTIRE LABEL BEFORE USE For control 0I11eas ICt.llOcephBlirJes sp.) on dogs alii puppies 8 weeks of age and older. ProMlIfis' Canine F/eB Control is. convenient single spot application that provides control of ex~ting flea infes tatioos and proteC1S against reinrestatlon. It may also be used to prevent infestation in flea iTee dogs and puppies 8 weeks 01 age and older taken into allea·contaminated environ""n!. ~IJs lleas that may causa flea allargy dennatn~.

A single dose of ProMeris' Can". Rea Control is effective for up to 6 weeks in controlling fleas. Apply a single dose prior to a><POsum. Montlt; application ~ recommended for effective control 01 fleas and to prevent reiriestation. 00 not apply more than 01lC!! monthly. ProM,ris' Canine Rea Control contains the active ingRld~nt metaflumizooe. Metaflumizone provides aligh level of control 01 fleas by bIoc~ng gated sodium channels.

P'1Q81

Benefits of ProMeris' Cani.e Rea CoatTol inchnte: Stops alii controls infestations of f~as Prevents reinfestation of fleas Up to 6 weeks of flea control with a single ~eatrn.nt KIlls tha f~.s that may cause flea allergy dermattt~ Convenient and easy 10 use applicator Waterproof Effective on indoor or outdoor dogs Avai~ble on~ irom a licensed voterina!), prolessio"" Pleasant eucalyptus smell

DIRECTIONS FOR USE

PBIlel

It ~ a violation 01 Federal law to use 1!1~ product in a manner ioconsislarJ wtth its labeling. For external use on dogs and PIJIlpies 8 weeks 01 age and oWer. 00 NOT USE ON ANY ANIMALS OTHER THAN OOGS.

PACKAGING

ProMeris' Canine Flea Control is available in li,e packaging presentations for different body weights 01 dogs .nd puppies 8 weeks of age .111 older Isee table below). £eeh package contains three or s~ individual applicator wbes to provide monmy treatments. The dog body we~hts alii product wlllTl!l sizes are' specified on illlividuallabels of canons. roil pouches and applicatnl>.

Package Dog Sizellhs) Fl. ol1applicator

XS Dogs 11 pounds and ulllerl:; 11) 0.023

S Dogs over 11 ,nd up to 22 pounds I> 11·22) 0.045

M Dogs over 22 alii up to 55 pounds 1>22·55) 0.113

l Dogs over 55 and up to 88 pounds (>55-88) 0.180

I Xl Dogs over 66 and up to 110 pounds (>86·1101 0.225

HOW TO APPLY

~~~~ 1. Remove one applicator from the foil pouch. 2. Hold applicator upright for thlBe secollls to avoid splash when oparnng. J. Use lIW hands to hold hnth ends 01 appl~ator whh printed side facing the user and narrow end

pointing up, ... nt and "NaY irom the user. . 4. To open, oord the tip 01 applcator towards the user and break along the fracwre line. 5. 00 not SQueeze applicator when opening. Avoid toucllng applicator opening. 6. Fold tip back against the printed side 01 ap~icator. Hold applicator in one hand using thumb

In hold tip back against the printed side of applicator. 7. Push the opan tip I!1rough dog's hair coat onto dog's skin between the shoulder blades. Squeeze

applicator to apply the entire contents to ttle dog's skin. 00 not apply on the surlace of dog's hair coat. Avoij contact with treatad area until dry.

8. Avoid allowing the product III come in contact with yo .. skin. 9. Place empty applicator in trash.

Palle3

STORAGE AND DISPOSAL

Do not contaminate water, food, orleed by storaga or d~posal. Stofllge: Stom in a cool dry place. Container Disposal: llLnlltt: 00 not reuse this container. Place in tresh or oflerfor recycling n availab~.

PilIJCI4

~: Coli your local solid waste agency for disposal instruction. Never pleca unused product down any indoor or outdoor drain.

FIRST AID FOR HUMANS

Hawe ttl. product applicator. c,"on or this product label with you when contacting a poison control center or medical proressianal. If in eyes, hold eye open alii rinsa slowly nnd gantly with watar for 15·20 minulas. Remove contact lenses, il present, aitar Ihe fin;! 15 minu!!!s, til" continue rin~ng. Call a poison control center or doctor lor trentment advice.

PRECAUTIONARY STATEMENTS

HlIlanis to Humans

CAUTION Causes moderate eye initatian. Avoid contact with eyes or clothing. Wash tllorouglt; with soap and water after handling and Defumeating. drinking, chewing gum. or using tobacco.

Hazards to Domestic Animals

For extemal usa only. FOl use on dogs only. DO NOT USE ON ANY ANIMALS OTHER TllAN DOGS. 00 not use on puppies younger l!1an 8 weeks of age. Certain medications can interact wit1l pesticides. ConsUlt a veterinarian belo", using 1!1~ product on aged, dabilitated, medicated, pregnant or nursing anime~. Individual sensitivities, whi" rare, may occur after the use of any pesticide product. If skin i"itatian, change in behavior, vomiting ord~rrhea ~ absOlVed alii "",s~ts after tha use 01 the prodoct, call your vetarinarian imrrediately. . For turther product infonnation,calll-886-PROMERIS (1·886·176·6374).

Physica'and Chemical Hazards Combustible. 00 not use or stora near heat or open flame.

UMITED WARRANlY AND DISCLAIMER

Directions for use of this product are based upon tests believed to be reliable. The usa of th~ product being beyond control of the seller, no guarantee, express or implied, is ... de as to the effects of such use or the results to be obtained n not used in accordallC!! whh printed directions and established sere practice. To tire extent consistent with ,pplicablelaw buyer's exclusive remedy and seller's exclusive liabilny for any and all claims, losses, damages or inillies resu"ing from the 008 or handling of this product whether or not besed in contract. negligence. strict liabiflty in tort or othelwisa shall be linitad, at the saller's opt~n. to rep~cement 0\ or the repayment of the purchase price for. the quantity of product with respect to which damages ara claimed.

Fort Dodge Animal Health P.O. Box 25945 Overland Park, KS 66225

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