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V'MlSID3'M NOll 

1

REGISTRA TION 

2517-142 
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ISB'S Front-end PRlA Completeness Screen 

Draft 3; 10125107 

A Receipt Date: AUG 1 1 2010 EP A Reg. Number: ,'15/7 -/?u.E 

Check List Item • .... ..... . ,'., ......... ' .. ",' . Yes No N/A 

Has the PRIA Fee been Paid; is a copy of the check or f-0 

Pay. gOY receipt included in the Submission Package? FlV X . -.~ 

Is an Application Form (EPA Fom18570-1) Included in the 

Suhmiss'ion Package, is it completely filled out and signed ~ including package type? 

~.-~----

Is a Confidential Statement of Formula (EPA Fonn 8570-

29) Included in the Submission Package, is it completely I 

lilled (lut ancl signed (boxes 1-21)? ~ .. -

Is a Formulator's Exemption Statement (EPA Form 8570-

27) Included in the Submission Package? '/ -- ~--~ ...• 

Is <I Certification with Respect to Citation of Data (EPA 

':orm ij570-34) Included in the Submission Package? J -.--

Is a Data Matrix (EPA Form 8570-35) Included in the ;x: Submission Package? .1---_._-

'l Is a Label Included in the Submission Package? --

Are Data Included in the Submission Package? "f- -- ~ .. 

Is the Submission an Amendment? -~--

2
Material to be added to an e-Jacket or Jacket 

Reg.No. ________ 251r -I ~~_ It'l(<</;{f\. ~ ~) 

Desc ri ption: -----1h"",J-,,-O J""h • ...L) --,W~~'r-+·· ,-,-"SVc.ll--.lL:A\.LkJ.-'" d/)""-.L--->..l Q=,IbQ~------,-t-----,,(=-S'---,-,f3.=. -'"'(=~---")"-

1 . ~ Placement within the e-Jacket/Jacket r Default: (chronological, top = newest) 

2. 

D File Location: (PDF page number) 

Send to Data Extraction contractors this material: 

tflI Newly stamped accepted label 

D Notification 

t1 New CSFQ.C\.)((. t Al~ I l'i\6AJ.&<.y-e 

D Other: __________ _ 

Attach this coversheet to the top of the material or jacket. It must be 

well-organized and clipped together - NOT STAPLED. Then give the 

material with this coversheet to ~staff in the Information Services 

Center (Room S-4900). 

Reviewer's Name: Rosanna louie-Juzwiak 

Phone: 308-0037 Division: RD 

Date: '2e M l\fL7P \ 1 

3
REGISTRATION JACKET INTRA-TRANSFER REOUEST 

(PLEASE FILL OUT FORM COMPLETELY) 

,~ ! J Transfer File To: :"Ichcml {.ek?'?AA Phone, ____ _ 

Reason For Transfer: 

o RSB CHEMISTRY REVIEW 

o CODING (Macfadden) 

o ACTION COMPLETED 

o PRECAUTIONARY LABEL REVIEW 

o WITHDRAW PENDING APPLICATION 

o OTHER ________________________ ___ 

TRANSFERRED FROM: Senedn Alemn <Macfadden) Phone: 305-6178 

DATE REQUEST: PM TEAM: _____ _ 

(If Applicable) 

REGISTRATION NUMBER (S) OF JACKET (S) TO BE TRANSFERRED 

(PLEASE INDICATE VOLUME NUMBER IF APPLICABLE) 

REGISTRATION # COMMENTS LOCATION OTHER INFORMATION 

.2H? - 11-2 

SPECIAL COMMENTS: 

FOR FILE ROOM STAFF USE NOTIFY REQUESTOR: 

DATE TIME INITIALS 

4
, ", PPIS Deficiency Nutice 

PMNUMBER:~ REGISTRATION NUMBER: ').)'i'f - 19-2 

Transferred from: Senedu Alemu (M:acfadden) Date Processed: J /2 q/).Oll 

This jacket has been found to be deficient according to established EPA data processing 

guidelines for the following reasons: 

1. Current accepted label dated I 1 __ _ 

__ is missing from the jacket. __ is mlssmg acceptance stamp. 

__ Acceptance stamp is missing date and/or registration number. 

__ Is missing the following information: _______________ _ 

2. Acceptance letter dated----1 __ 1 and associated label are inconsistent 

concerning: __ Acceptance date. __ Product name. __ Registration number. 

3. Conunents letter associated with label dated __ I __ I___ is missing from the jacket. 

4. Accepted (Basic 1 Alternate) CSF dated 1 1 __ _ 

Is missing from the jacket. __ Is misfiled or has wrong registration number. 

__ Sole active ingredient source product has been cancelled. 

5. VActive and inert chemical percentages do not equal 100%. 

6. Other information missing / inconsistent within the jacket. See below for details. 

5
U.S. ENVIRONMENTAL PROTECTION 

AGENCY 

Office of Pesticide Programs 

Registration Division (7504P) 

1200 Pennsylvania Ave., N.W. 

Washington. D.C. 20460 

NOTICE OF PESTICIDE: 

0' Registration 

o Reregistration 

(under the Federal Insecticide, Fungicide, 

and Rodenticide Act, as amended) 

Name and Address of Registrant (include ZIP Code): 

Sergeant's Pet Care Products, Inc. 

c/o Exponent, Inc. 

2625 South 158'h Plaza 

Omaha, NE 68130 

EPA Registration No. Date of Issuance: 

2517-142 MAR 23 2011 

Term of Issuance: 

Conditional Registration 

Time-limited: see conditions below 

Name of Pesticide Product: 

Sergeant's Fipronil + Cyphenothrin + 

Methoprene Squeeze-on for Dogs 

Note: Changes in labeling'differing in substance from that accepted in connection with this registration must be submitted to and 

accepted by the Registration Division prior to use of the label in commerce. In any correspondence on this product always refer 

to the above EPA registration number. .. . .' 

On the basis of information furnished by the registrant, the above named pesticide is hereby registered 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 §3(c)(7)(a) provided that: 

I. This registration is time-limited and expires two years from the date this product is first released 

for shipment. 

You must provide the Agency with a projected release for shipment date within 30 days of the 

date of this Notice of Registration. The Agency will calculate the expiration date based on the 

projected release for shipment date until an actual release for shipment date is provided in writing. 

2. Consider limiting the formulations of each product to one basic confidential statement of formula. 

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. 

3. As a condition of registration for this product, within one year from the date of this registration, 

you must submit the results of Storage Stability and Corrosion Characteristics studies, 

corresponding to OCSPP Guidelines 830.6317 and 830.6320, respectively, including interim 

reports made at 0, 3, 6, 9, and 12 month intervals. 

Page lof6 

6
4. The approval of this registration is contingent on the Agency's review to determine that the study 

to fulfill OCSPP Guideline 830.1800 - Enforcement Analytical Method, is acceptable to support 

the registration. 

5. Within one year of the date on this Notice of Registration, and prior to fonnulating this product, 

you must provide the Agency the following: 

a. The registration number and establishment number of the manufacturing or technical 

product( s) from which the active ingredient is derived. 

b. The name and address of the entity from which the manufacturing product(s) was 

obtained; and 

c. A copy of the bill of sale for this manufacturing product(s). 

6. Within 30 days from the date of this registration, in accordance with FIFRA §3(c)(l)(F) and 

3(c)(2)(B), you must submit a copy of all offers to pay compensation and evidence of their 

delivery, used to support the data required for this product. 

7. You must submit quarterly enhanced incident reports and quarterly sales infonnation in doses 

sold for this product for the quarter that begins on April 1,2011. The quarterly reports are due 

two months after each quarter ends. 

Please flag any Confidential Business Infonnation as such. Enhanced incident reporting should 

be submitted to the Product Manager. Quarterly sales infonnation should be submitted to the 

Registration Division (7504P), to the Product Manager's attention. 

The following is a list of information that must be iucluded iu 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 (speciry) 

Breed: (as reported by pet owner) 

Age: months or years 

Sex: M, F, or neutered 

Weight: pounds 

Primary Route of Exposure: dennal, oral, other animal, inhalation, other 

Body System: neurological, dennatological, GI, respiratory, ocular, other 

Major signs noted with separate column for each sign, using standard tenninology 

Time to Onset: (hours, days) 

Treated by veterinarian: yes or no 

First time product used: yes or no 

Page 2 of6 

7
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 

8. 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 cats (misuse or secondary exposure) showing number of 

incidents of each severity code for each route of exposure. 

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, I 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, IS yr, > IS yr. 

A summary table showing the number of dog incidents for each severity code for each pet 

weight range on the product label. 

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. 

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. 

9. You must submit and/or cite all data required for registration of your product under FIFRA 

§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 §4. 

Page 3 of6 

8
All labeling comments below are in reference to the proposed master label, dated March 4, 20 II. These 

comments apply to all submitted draft labeling, including the master label, the color mock-up labels, and 

the proposed text and graphics for the stickers and magnet: 

10. Throughout the entire label, add "starts killing" so that the claims read as follows: 

"Starts killing in as little as I hour" 

"Starts killing in as little as I hour." 

II. Throughout the entire label, per the Acute Toxicity and Companion Animal Safety review, 

change "up to 22 Ibs" to "4 to 22 Ibs" to include a minimum dog weight. 

12. On page I under the header Fleas, revise the following claims to add the underlined words, or 

delete struck-out words, as follows: 

"[Controls flea [einfestation fer HI' to [! 6 weeks]]" 

"[Researeh aemonstrates that [brana name] kills aaHlt fleas (starts ill as little as I hOHr), flea eggs, 

ana flea laryae alla flrevellts flHflae for HI' to feHr months.]" 

"[[brana Ilame] flrevellts aeveloflment of all flea stages fer Ufl to four mOllths.]" 

"[Prevents all flea stages (adult fleas (starts killing in as little as I hour), flea eggs, flea fluflae and 

flea larvae)]" 

"[Ki!!s flea eggs [larvae] [flre'o'ellts fluflae] fer HI' to 4 months]" 

"[Kills Flea Eggs & Flea Larvae [for 2 months] [Ufl to 4 mOllths]!]" 

"Kills a!! stages of the flea life eye Ie" 

13. On pages I and 2 under Multiple Infestations, revise the following claims to add the underlined 

words, or delete struck-out words, as follows: 

"[Kills fleas (starts killing in as little as 1 hour), flea eggs, ticks (starts killing in as little as I 

hour), chewing lice & mosquitoes][and prevents development of flea pupae]" 

"[Kills fleas (starts killing in as little as I hour), ticks (starts killing in as little as 1 hour), 

mosquitoes, chewing lice, flea eggs, and larvae alla flrevents fluflae]" 

"[Kills fleas (starts killing in as little as 1 hour), ticks (starts killing in as little as I hour), 

mosquitoes, flea eggs, and lice]" 

"[Kills Fleas (starts killing in as little as 1 hour) and Ticks [and mosquitoes](starts killing in as 

little as I hour) for up to 4 weeks!]" 

"[Ki!!s Fleas (starts ill as little as I hour), Tieks (starts ill as little as I hour), Flea Eggs & Flea 

Laryae for ufl to 16 Weeks]" 

"[Prevents and controls reinfestations oflisted pests for up to [I month] [4 weeks]]" 

14. On page 2 under Ticks, revise the following claims to add the underlined words, or delete struckout words, as follows: 

"[Kills ticks (starts killing in as little as 1 hour)]" 

"[Kills Ticks (starts killing in as little as 1 hour) for Up to [4 weeks]!]" 

"[Kills [all stages of] Deer Ticks (which may vector of Lyme Disease) for up to 4 weeks]" 

"[Kills Brown Dog Ticks (starts killing in as little as 1 hour)]" 

15. On page 2 under All Others, revise the following claims to add the underlined words, or delete 

struck-out words, as follows: 

Page 4 of6 

9
"[OHee a mSHtR treatmeHt is feesmmeHaea]" 

"[[Free] BfseflHfe aHa Calendar Stickers Inside]" 

"[pfeveHts aHa eSHtrsls feiHfestatisHs sf listed pests]" 

"[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] f£lif+[eaFdB" 

16. On page 3 in the Ingredients Statement, all Inert ingredients must be identified when electing to 

list the inert ingredients. 

17. On page 3, delete the optional statement "[Ingredient Statement may be on front or back label]" 

because the ingredient statement must be placed on the Front Panel. 

18. On page 4 under the Back Panel, revise the first sentence to read as follows: 

"[brand name] contains fipronil, cyphenothrin, and the insect growth regulator (IGR) (S)-

methoprene to effectively kill Fleas [(starts killing in as little as I hour)], Ticks [(starts killing in 

as little as 1 hour)], and kills mosquitoes and chewing lice." 

19. On page 6 in the How to Apply section, correct the reapplication interval from "4 weeks" to "30 

days" to be consistent with the interval stated under Frequency of Application. 

20. On page 6 under the Frequency of Application, add the underlined words in the following 

statements: 

"[Studies show that] [brand name] kills fleas (starts killing in as little as I hour) for up to three 

months. If your pet is at high risk for flea reinfestation [, or in a highly infested environment], 

apply monthly." 

"[Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, then 

within 48 hours for up to 28 days." 

21. On page 7 under the Storage and Disposal statement, replace "Container Handling" with 

"Container Disposal." 

22. On page 7 in the Warranty statement, remove the brackets within the paragraph so that if used, the 

Warranty statement is present in its entirety. 

23. On page 9 under the End-back/side Panel section, delete the "Optional Insert or Package Copy" 

statement because the Agency has not reviewed the optional insert as part of the labeling for 

approval. 

24. Note that should you wish to add a reference to the company's website on your label, then the 

website becomes labeling under FIFRA and is subject to review by the Agency. If the website 

content is false or misleading, the product would be deemed misbranded and unlawful to sell or 

distribute under FIFRA § 12(a)(I)(E). 40 CFR 1 56.l0(a)(5) list examples of statements EPA may 

consider false or misleading. In addition, regardless of whether a website is referenced on your 

product's label, claims made on the website may not substantially differ from those claims 

approved through the registration process. Therefore, should the Agency find or if it is brought to 

our attention that a website contains false or misleading statements, or claims substantially 

differing from the EPA-approved registration, the website may be referred to the EPA's Office of 

Enforcement and Compliance Assurance. 

25. Revise the EPA Re istration Number to read: "EPA Re istration No. 2517-142." 

Page 5 of6 

10
[fthe 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. Two copies of the finished labeling must be submitted 

prior to releasing the product for shipment. Ifthese conditions are not complied with, the registration will 

be subject to cancellation in accordance with FIFRA sec. 6( e). Your release for shipment of the product 

constitutes acceptance of these conditions. A copy of your label stamped "Accepted with Comments" is 

enclosed for your records. Please contact Rosanna Louie-Juzwiak at (703) 308-0037 with any questions. 

Enclosure: Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-on for Dogs Label, Stamped 

Accepted with Comments 

s;?nZdL Date: 

MAR 23 

Richard Gebken, Product Manager (10) 

Registration Division, Insecticide Branch 

EPA Fonn 8570-6 

Page 6 of6 

11
Sergeant's@ Master Label 

4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE 

Information in [ ] is optional. Page I of 10 

)<];;..\,.;.,; .• , ..•..••.•.•..........•. ". ...• • .......}~g.(;'~Q y~E~~()l\l 

FIP~ONII,+GypHENQ:rH.R.IN:E~ETHQPRENE 

[Option text appears in brackets-the final product label may include some or all of the optional 

text on front, back or side panels. The CRP required text will not change.] 

Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On 

for Dogs 

[ABNs] 

[(Sergeant's®) (Sentry®) FRONTIER GOLD (Spot On) for dogs] 

[(Sergeant's~ (Sentry®) EctoadvanceTM (Spot On) for dogs] 

ACCEPTED 

with COMMENTS 

In EPA Letter Dated: 

MAR 23 

[Apply to puppies over 12 weeks old] 

[Apply to puppies 12 weeks or older] 

Unde. the Federal Insecticide 

Fungicide, aDd ROdenticide Act: as amended, for the pesticide 

registered under EPA Reg. No. 

2.517-1q,?-

[Mosquitoes] 

[Fleas] 

[-Kills mosquitoes] [within 24 hours for up to 7 days] [and within 48 hours for up to 28 

days] 

[-Kills mosquitoes] 

[-Cefltrels flea reinfestatien fer up te [16 weeks]] 

[-Researeh demenstrates that [brand name] kills adult fleas (starts in as little as 1 MUr), 

flea eggs, and flea larvae and preYents pupae fer up te feur menths.] 

[-[brand name] preYents dewlepment efall flea stages fer up te feur menths.] 

[-Prevents all flea stages (adult fleas (starts killing in as little as I hour), flea eggs, flea 

pupae and flea larvae)] 

[-If dog is a high risk for flea re-infestation a once month application may be needed] 

[-Kills flea eggs [larrae] [preyents pupae] fer up te 4 menths] 

[-With (S)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle] 

[-With (S)-methoprene to Break Flea Life Cycle] 

[-With Insect Growth Regulator to Break Flea Life Cycle] 

[-Triple Action [!]:Fipronil and Cyphenothrin with (S)-methoprene IGR Effectively 

Breaks the Flea Life Cycle] 

[-Triple Action [I]: Effectively Breaks the Flea Life Cycler!]] 

[-Kills Fleas (starts in as little as I hour) up to [4 weeks]!] 

[-Kills Flea Eggs & Flea Larvae [for 2 months] [up te 4 menths] !] 

[-Prevents Flea Eggs From Developing Into Biting Adults] 

[-Kills all stages ef the flea life eyele] 

[Multiple Infestations] 

[-Flea & Tick Control for Dogs & Puppies 12 weeks old and older] 

[-Kills fleas (starts killing in as little as I hour), flea eggs, ticks (starts killing in as little 

as I hour), chewing lice & mosquitoes][ and prevents development of flea pupae] 

[-Kills Fleas, Ticks and Mosquitoes] 

12
Sergeant's® Master Label 

4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE 

Infonnation in [ ] is optional. Page 2 of 10 

[Ticks] 

[-Kills fleas (starts killing in as little as I hour), ticks (starts killing in as little as 1 hour), 

mosquitoes, chewing lice, flea eggs, and larvae and prevents pupae] 

[-Monthly flea, tick, mosquito, chewing lice, and flea egg protection] 

[-Monthly flea, tick, mosquito and chewing lice protection] 

[-Kills fleas (starts killing in as little as 1 hour), ticks (starts killing in as little as 1 hour), 

mosquitoes, flea eggs, and lice] 

[-[Seven] [7] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] 

chewing lice, flea eggs, flea larvae [&] [and] prevent the development of flea pupae lJ 

[-[Six] [6] Way [Action] [Effectiveness] [Control] to kill fleas, ticks, [mosquitoes,] 

chewing lice, flea eggs [&] [and] flea larvae] 

[-[4 Week] [Flea and Tick & Treatment] 

[-[Four (4) Week] [Flea, Tick, Mosquito and Chewing Lice Control] 

[-When used monthly [brand name] completely breaks the flea life cycle and controls tick 

and chewing lice infestations.] 

[-4 week Flea and Tick Treatment!] 

[-Once A Month Flea and Tick Treatment] 

[-Kills Fleas (starts killing in as little as 1 hour) and Ticks [and mosquitoes](starts killing 

in as little as 1 hour) for up to 4 weeks!] 

[-Kills Pleas (starts in as little as 1 hour), Ticks (starts in as little as 1 hour), Plea Eggs & 

Plea LaFYae fOF UjJ to 16 Weeks] 

[-Prevents and controls reinfestations of listed pests for up to [1 month] [4 weekslJ 

[-Kills ticks (starts killing in as little as I hour)] 

[-Kills ticks including those that may transmit Lyme disease] 

[-Kills Ticks (starts killing in as little as 1 hour) for Up to [4 weeks]!] 

[-Kills [all stages of] Deer Ticks (which may vector of Lyme Disease) for up to 4 weeks] 

[-Kills Ticks (starts in as little as 1 hour)] 

[-Kills Ticks including Deer Ticks for up to 4 weeks] 

[-Kills Brown Dog Ticks (starts killing in as little as 1 hour)] 

[-Kills [Brown] , [American,] [and Lone Star] Dog Ticks for up to 4 weeks] 

[-Kills Rhipicephalus sanguineus for up to 4 weeks] 

[-Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!] 

[All Others] 

[-For Dogs and Puppies 12 weeks of age or older] 

[-For Dogs [UJl-1 to 22Ibs], [23-44Ibs], [45-88Ibs], [89-132Ibs] 

[ -Fast Acting] 

[-Waterproof] 

[-Effective after bathing and exposure to water and sunlight] 

[-Long Lasting] 

['Once a month treatment is recommended] 

[-Apply monthly] 

[-A once monthly application is required [apply monthly to control] [for] chewing lice.] 

[-Rapid elimination of chewing lice infestations] 

[Controls mites that may cause sarcoptic mange] 

[-Three Applications] and/or [3 Month Supply] or [12 Week Supply] 

[-Best if used year round!] 

13
Sergeant's® Master Label 

4 March 2011 Version 10.1 

Information in [ ] is optional. Page 3 of 10 

[-4 Week Dose!] 

[-(ICON Showing 4 Week Protection)] 

[-I Month Dose!] 

[-Easy to Use Application] 

[-Specially Formulated for Dogs and Puppies Over 12 Weeks] 

[-[Free] Calendar Stickers Inside!] 

[-[Free] BroclHlre and Calendar Stickers Inside] 

[-Apply once every [4 weeks]!] 

EPA Reg. No. 2517-RUE 

[-[Free with purchase] [Free inside] Monthly Application Reminder [Magnet] feHtJt 

[eartIH 

[-Effective after bathing and exposure to water and sunlight] 

["Prevents and controls reiBfestatioBs of listed pests] 

[" [Free vrith plH'chase] [Free iBside] Monthly l\flplicatioB RemiBder [Magaet] [clip] 

[card]] 

[-3 applications] 

[-Fiponil (9.8%) + cyphenothrin (5.2%) + s-methoprene (8.8%)] 

[-US and Foreign patents pending] 

[-Lift [here] for more information] 

[-For year round protection, apply (brand name) monthly] 

[3 Applications] 

[For use ONLY on dogs] 

[~1 to 221bs] 

[23-44Ibs] 

[45-88Ibs] 

[89-132 Ibs] 

[over 12 weeks of age] 

[For Dogs & Puppies (12 weeks or older and) up to 22Ibs.] 

[For Dogs 23-44 Ibs.] 

[For Dogs 45-88 Ibs.] 

[For Dogs 89-132Ibs.] 

[ ] - Denotes Optional Statements and/or Images that May be Used on Front, Back 

or Side Label Panels 

[IBgredieBt StatemeBt may he OB front or hack lahel] 

ACTIVE INGREDIENTS: 

Fipronil .......................................................................... 9.8% 

Cyphenothrin ................................................................. 5.2% 

(S)-methoprene ............................................................. 8.8% 

OTHER INGREDIENTS*: ...................................... 76.4% 

TOTAL: 100.0% 

[*diethylene glycol monoethyl ether] 

14
Sergeant's@ Master Label 

4 March2011 Version 10.1 EPA Reg. No. 2517-RUE 

Information in [ ] is optional. Page 4 of 10 

KEEP OUT OF REACH OF CHILDREN 

WARNING 

See [Back][or][Side] [Label Panel[s] for Additional Precautionary Statements 

NET CONTENTS: 

Contains (3) [0.023 fl oz] [0.67 ml] applicators 

Contains (3) [0.045 fl oz] [1.34 ml] applicators 

Contains (3) [0.091 fl oz] [2.68 ml] applicators 

Contains (3) [0.136 fl oz] [4.02 ml] applicators 

J11{G~;P~i1';'·· ·~J>k;P'~0\i·· •• ···· .. ,X<?;, •..• >·· •.• \./.:;~9~§~P];;~¢ID,9N 

~IIlRP.JmIj-l;QX'Il.EIENPTIIRI~:+M$mOIll{EN1li 

[BACK/SIDE CARTON LABEL - MASTER LABEL] 

[brand name] contains fipronil, cyphenothrin, and the insect growth regulator (IGR) (S)-

methoprene to effectively kill Fleas [(starts killing in as little as I hour)], Ticks [(starts killing in 

as little as I hour)], and kills mosquitoes and chewing lice. The active ingredients in [brand 

name] feature a sustained release formula developed for fast acting [and long lasting] control of 

fleas, ticks, [mosquitoes] and chewing lice for up to [ I month] [[ 4] [four] weeks] on dogs. 

READ ENTIRE LABEL BEFORE EACH USE. 

USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS. WARNING. Causes substantial but temporary eye injury. Do not 

get in eyes or on clothing. Harmful if swallowed. Harmful if absorbed through skin. Prolonged or 

frequently repeated skin contact may cause allergic reactions in some individuals. Wash hands 

thoroughly with soap and water after handling and before eating, drinking, chewing gum, using 

tobacco, or using the toilet. Remove and wash contaminated clothing before reuse. 

HAZARDS TO DOMESTIC ANIMALS. For external use only. Do not use on puppies under 

12 weeks of age. Individual sensitivities, while rare, may occur after using any pesticide product. 

[Some dogs may experience temporary startle effects when any product is applied.] Dogs may 

experience some temporary irritation at the site of product application. If signs persist, or become 

more severe within a few days of application, consult a veterinarian immediately. If your dog has 

an unusual reaction to the initial application, consult a veterinarian before repeating treatment. 

Certain medications can interact with pesticides. Consult a veterinarian before using on 

medicated, pregnant, nursing, debilitated or aged dogs. Call 1-800-781-4738 for 24-hour 

assistance. 

15
Sergeant's® Master Label 

4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE 

Information in [ 1 is optional. Page 5 of 10 

FIRST AID 

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 control center or doctor for further treatment advice. 

If On Skin • Take off contaminated clothing. 

Or Clothing • Rinse skin immediately with plenty of water for 15-20 minutes. 

• Call a poison control center or doctor for treatment advice. 

If Swallowed • Immediately call a poison control center or doctor. 

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

• Have person sip a glass of water if able to do so. 

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

HOT LINE NUMBER 

Have the product container or label with you when calling a poison control center or doctor, or going 

for treatment. For more information on this pesticide product (including health concerns, medical 

emergencies or pesticide incidents), you may call 1-800-781-4738. 

NOTE TO PHYSICIAN OR VETERINARIAN 

Treat patient symptomatically 

. "Gi[;'ii.'.'" .. ·.,.'.,.,·'· ... :7};;;i"i'!>:(.i~$gME]l;Z;1!J9N J!'I~~QNJ:I.-I-~¥PJIEN(>jmuN:*METH()PRENE 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 

DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU 

AND YOUR DOG, READ ENTIRE LABEL BEFORE EACH USE. FOLLOW ALL 

DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL 

USE ON DOGS ONLY. DO NOT USE ON RABBITS. DO NOT USE ON OTHER 

ANIMALS. 

DO NOT USE ON CATS. May be toxic and potentially fatal if applied to or ingested by cats. 

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age. 

Weigh your dog to be sure you are applying the right dose formulated for the weight of your dog. 

Do not treat your dog with more than one pesticide product at a time. Over dosing your dog can 

result in serious illness and even death. Best if used year round. Certain medications can 

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged, 

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known 

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated 

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that 

actively groom or engage in close physical contact with treated dog may be at risk of serious 

harmful effects. The most common signs of ingestion are excessive salivation and foaming at 

the mouth. If these symptoms occur immediately feed your dog and continue to monitor your 

pet for the next 24 hours. If symptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats 

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. 

16
Sergeant's® Master Label 

4 March20ll Version 10.1 EPA Reg. No. 2517-RUE 

Infonnation in [ I is optional. Page 6 of 10 

If your dog is exhibiting signs of and/or are being treated for skin dennatitis, talk to your vet 

before applying any topical flea and tick control product. 

Sensitivities may occur after using ANY pesticide product on dogs. Dogs may experience 

some temporary irritation at the site of product application. If signs of sensitivity occur 

bathe your dog with a mild soap and rinse with large amounts of water. If signs continue, 

consult a veterinarian immediately by calling 1-800-781-4738. 

[{ Outer Packaging}] 

How to open: Remove product tubes [vial] from the package. Separate one tube from the others. 

Holding the tube [vial] with notched end pointing up and away from the face and body, cut off 

the narrow end at the notches with scissors. 

How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to 

apply all of the solution to the dog's skin, as directed below. Repeat application may be made if 

necessary, but do not apply more often than once every 30 , ..3 "-.. . days 4 weeks. -n n-

[Optional drawings that mayor may not appear on finished 

label] 

FREQUENCY OF APPLICATION 

Use [brand name] monthly for complete control of flea, tick [and] chewing lice [and to kill 

mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas (starts killing in as little 

as 1 hour) for up to three months. If your pet is at high risk for flea reinfestation [, or in a highly 

infested environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing 

lice. [Brand name] kills mosquitoes within 24 hours for up to the first 7 days after treatment, 

then within 48 hours for up to 28 days. [Brand name] remains effective, even after bathing, 

water immersion, or exposure to sunlight. Allow treated area to dry thoroughly. Do not reapply 

for 30 days. 

17
Sergeant's® Master Label 

4 March 20 II Version 10.1 EPA Reg. No. 2517-RUE 

~~~~~~page70f10~~~iI~~~~~~~~~ 

For Dogs Weighing ~:!. to 22 Ibs. [including small dogs and puppies, 12 weeks or older] 

{For cartons containing .67 ml (0.023 fl. oz.) applicator tubes} 

Apply one tube (.67 ml)(O.023 fl. oz.) [as a spot to the dog's back between the shoulder blades] 

[from the back of the neck to a point midway between the neck and tail]. 

For Dogs Weighing Between 23 - 44 Ibs. 

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube} 

[Apply one tube (1.34 ml) (0.045 fl. oz.) as a spot to the dog's back between the shoulder 

blades.] [from the back of the neck to a point midway between the neck and tail]. 

For Dogs Weighing Between 45 - 88 Ibs. 

{For cartons containing 2.68 ml (0.091 fl. oz.) applicator tube} 

Apply one tube (2.68 ml)(0.091 fl. oz.) [as a spot on the dog's back between the shoulder blades] 

[from the back of the neck to a point midway between the neck and tail]. 

For Dogs Weighing 89 - 1321bs. 

{For cartons containing 4.02 ml (0.136 fl. oz.) applicator tube} 

Apply one tube (4.02 ml)(O.l36 fl. oz.) [as a spot on the dog's back between the shoulder blades] 

[from the back of the neck to a point midway between the neck and tail]. 

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool 

[below nOF (25°C)] dry place inaccessible to children and pets. Do not refrigerate. Protect 

from direct sunlight. 

CONTAINER DISPOSAL Hf.NDLlNC: If empty: Non-refillable container. Do not reuse or 

refill this container. Offer for recycling if available. If partly filled: Call your local solid waste 

agency for disposal instructions. Never place unused product down any indoor or outdoor drain. 

[WARRANTY 

Read the entire Directions for Use and Warranty before using this Product. By using this 

product, user or buyer accepts the following warranty. HThe directions for use of this product 

are believed to adequate and must be followed carefully. It is impossible to eliminate all risks 

associated with the use of this product. Unintended consequences may result because of 

unknown factors. All such risks shall be assumed by the user or buyer.H Sergeant's is 

committed to providing high quality products. To the extent consistent with applicable law, 

Sergeant's makes no warranties, express or implied, of merchantability or of fitness for a 

particular purpose or otherwise, that extend beyond statements on this label. To the extent 

consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not be liable for 

indirect, special, incidental or consequential damages. To the extent consistent with applicable 

law, the exclusive remedy of the user or buyer shall not exceed the purchase price paid.] 

[If you have questions or comments about this product, please write: Sergeant's Consumer 

Response, P.O. Box 540399, Omaha, NE 68154-0399.] 

18
Sergeant's® Master Label 

4 March 2011 Version 10.1 EPA Reg. No. 2517-RUE 

Information in [ ] is optional. Page 8 of 10 

In Case of Emergency, call: 1-800-781-4738 [For more information] [Visit us at:] 

[www.sergeants.com] 

Non-Emergency call1-800-224-PETS (7387) [Made in USA] 

Distributed by: 

Sergeant's Pet Care Products, Inc. 

P.O. Box 540399 

Omaha, NE 68154-0399 

EPA Reg. No. 2517 -RUE 

EPA Est. No. XXXXX-XX-XXX 

[BAR CODE AREA] 

[How to Apply - May contain graphics illustrating product use, e.g., dog with a drop falling 

onto its neck from a vial on front, side, or back carton label and/or applicator labeling.] 

[ {Outer Packaging} ] 

[Application Instructions] [Directions for Use] 

How to open 

1. Remove product tubes [vial} from the package. 

2. Separate one tube from the others. Holding the tube [vial} with notched end pointing up 

and away from the face and body, cut off the narrow end at the notches with scissors. 

How to apply: 

1. Invert tube over dog and use open end to part dog's hair. 

2. Squeeze tube firmly to apply all of the solution to the dog's skin [as a spot to the dog's 

back between the shoulder blades.] [or] [from the back of the neck to a point midway 

between the neck and tail.] 

[Flea life cycle diagram] [Flea Life Cycle][Sample coloring and layout may be different on 

final label] 

[Look at the Label (Look at the Label icon) [Easy] 6 Step [Spot On] [Squeeze-On] [Topical] 

Checklist 

• Read the label completely and follow directions 

19
Sergeant's® Master Label' 

4March2011 Version 10.1 EPA Reg. No. 2517-RUE 

Information in [ ] is optional. Page 9 of 10 

• Weigh your pet 

• Do NOT use Dog products on Cats 

• Do NOT treat with more than one pesticide product at a time 

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets] 

[Brand Name] 

[3] [Month [Treatment] [Application] Tracker] 

[For year-round protection, apply [Brand name] monthly.] 

[Pet's Name (Empty blank for owner to fill in name)] 

[First] [1st] [Second] [2nd] [Third] [3rd] 

[Dose] [Treatment] [Application](Empty blank for owner to fill in date)(Date: MM/DDIYY)] 

[calendar stickers with brand name] 

[Place stickers on your calendar as a reminder to reapply [brand name] [in 30 days.] 

[Monthly Application Reminder Magnet (image of reminder magnet)] 

[Enclosed for your convenience is an application reminder magnet. Push the (reset) button, and 

the reminder light will blink twice. The reminder tag is now set for 30 days. At the end of 30 

days the reminder light will blink, reminding you to reapply [Brand name]. Press the button 

once and the blinking light will stop. Press the button again and this will reset the timer for 

another 30 days.] 

'" Adult Flea @ AdultFlea 

.". flea eggs ~ fleaeggs 

.., flea larvae ~ flea larvae 

.. flea pupae ~ flea pupae 

,. ticks @ ticks 

+ Brown Dog lick ® Brown Dog Tick 

+ DeerTick ® Deer lick 

~ American Dog lick @ American Dog lick 

f' chewing lice @ chewing lice 

~ Lone Star lick @ Lone Star lick 

~ mosquIToes @ mosquIToes 

[Optional graphics above mayor may not appear on finished label] 

(END OPTIONAL INSERT OR PACKAGE COPY) 

20
Sergeant's® Master Label 

4 March 2011 Version 10.1 EPA Reg. No. 25l7-RUE 

Information in [ I is optional. Page 10 of 10 

Front Label 

l@o<)NorJ 1 U'JII! ot< 

{Brand Name}: CPT. 

Fipronil 9.8% w/w, Cyphenothrin 5.2% w/w, 

(S)-methoprene 8.8% w/w 

0.023 fl oz (or) 0.045 fl oz (or) 0.091 fl oz (or) 

0.136 fl oz {label code} 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

WARNING: Read directions and precautions 

before using. Use scissors to open. 

EPA REG. No. 2517 -RUE {label code} 

21
J 

3 

~ 

I 

, 

J 

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<) 

Brand Y" 

fordogs 

READ ENl1RE LABEL BEFORE EACH 

~~ USE. USE ONLY ON DOGS AND PUPPIES OVER 12 WEeKS OF AGE. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HU\1ANS, WARNING: GaI.Ises SI.IbsliiI'ltia! oot !tmporary tqe i$l'f. Do rot get in eyes or on cklIhillg. HimIfuI ~ swalowed. Hamifullt aimrOOd through skill.1'lWJnged Cf frfqJeolIy ~ed skin cootact may cause aIler9ic reactions m some indMcIuaIs. WiUh 

hands thorough~with soap and walei' aile!' Imding Md before ootlng. ooniing, chewiflg gxn, using toboccQ, or using the toilet Re!oove 

and wash contaminatlld clo!hill9 boNre!'Me. 

HAZARDS TO DOMESl1CN4MAl$.Forexterml useooly.Oo not I.ISeOO puppieslJ'ldl:r t2we-eksof age.lntlNiduai swsM'rt\es,lIillle rare, may 0CC\If after using arll pesllcm ~ Some dogs may ~~ !€ffl~ary slaJile effocts whef'l any product is a~ied Dogs 

ma'/,exp<fience some temi»"!ry irritation at the site 01 product a~icatioo. n signs persist, Of becoma mOle severe within a few da'J'S of 

application, COM!AI a uetefinariao immooa/etj.II)\1I.Irdog has an unusual reaction lo!he init~ applicatloo, coosult a veterirlariM baItte 

repooting treatment, Cer!aH1 medicallons can interact ,..ilh ~tickles. COflSU~ a vetl!finarian before uslng on medicated, pregflarlt, nursing, detiliialed or~eddll9S.GaH 1-8(1).78/-4738 lor24-hotx assistance. 

FIRST AID 

II In Eyes I -Hold eye open and rinse slowly and gently vAlh watedor tS:2-o;nrnutes. 

-RemoV<! contact lenses, il present, after the first 5 milutes, then continue rinsing eye. -Call a p050n control cenler or doctor lor further treatmenl advict!. 

liOn SkinOrCIothin9 I -Tilke off conlarninaledclothing. -Rinse skin immediately with plenty of waler lor t5-2O minutes. 

-Call a poison control center or doctor tor treatmenl aduice. 

It Swalowed \ -Call a p;lison control ct!nter or doctor immediatoly lor treatmenl advice. • Have person sip a glass ot waler ff able 10 swallow. - Do not induce \'OfIl~ing UI'I!ess loid to do so 'rJj a poison control ct!nter or doctor. • Do oot g~~ anything 'rJj mouth to an unCOIlSCKlUS pi1(SOIl. 

H01UHENUMBER 

Have the product container or laOOl with you when caRing a pcison control cenler ordoctor, or going tor treatmoot. For more inlOl11latioo Of! 

!his pesticide product IlflCWng health conC€l!ls,medical OOl~g.llfICles or pestlcio'e Incide~),_youmay call t-80()"78t-4718. 

NOTE TO PHYSICIAN OR VETERINARlI.H 

Treat patiantS)'ll1~maticaGy. 

DIRECTIONS FOR USE 

It is a violation ot Fed€filllaw to usa thiS product in a l!l3I'I!'l«incons!stefllv.ith tts Illbeling. DO NOT ALLOW CHILDREN TO APPLY PRODUCT. TO PREVENT HARM TO YOU ANO YOOR OOG, READ ENTIRE lABEl BEFORE EACH USE FOLLOW ALL DIRECTIONS AND PRECAUTIONARY STATEMENTS CAREFULLY. FOR EXTERNAL USE ON COGS ONlY, 00 NOT USE ON RABBITS. DO NOT USE ON OTtiER ANIMAlS. 

00 NOT USE ON CATS. May be tOl(ic and potenfuJly latal it appt«! tooringested by cats. FOR EXTERNAl USE ON DOGS OOLY. t::c rot US€ on puppies under t2 weeks 01 age. Weigh your dog to besure l'011ltn aWfiroa the right dose Iomlulated tor the weight ot your dog. Do 

not !reat your dog With more than one pesticide product at a tme. ~dosing your do;! can result in serious ill!less and e\'e(l dealh. Best if used year round. CIlfI81n medications can Inleract With pesticides. COI'IS\At a l'eleOOarian before using this prodJJct on!!ebiMa!1ld, aged, 

medicatoo, pregnant, or nursing dogs. Coosuft a ue{ffinailan belore using OIl dogs v.ilh known organ dysfuncflOll. 00 NOT USE ON CATS 0( 

animals other than dogs. Separate the treatoo dog !rom all other dogs and cats tor 24 hoors after trealmeot lias boon a~ Cats aM dcqs 

that actively groom or engage in close physical contact with treatoo dog may be at risk 01 seriOliS Mtmful effects. The most COIllmOO ~ 01 

ingeslion are excessiue salivatlOil and Imng at the mouth. ~ the$(! symploms occur immediatoly leed y(llll' dog and cootiml! to moo~Of 

y(lur dog tor the next 24 hOLlrn.lt symptoms ~sl call t-800-781-4738 to talk to a VillerinariM. Cats e.xnbltlng these same s;mplom$lrom infrastIon should be taken to the vetl!finalY'aIl Immediately. I! I'our dog is emitif!ng signs 01 and/oris being treated for sk1n detmali1is, t:i&to your vet iletore app.'ying any lopicall\ea am tick control product. 

Semltil'ities may occur alter using IJjY pesticide prodoct on dogs. Dogs may experience some terrrporary irritation at \he site of product application. H signs oisensitil'ity occur batIi& yourdog with a mild soap and rinse with large aJ!fO\R1ts 01 walel',l1 signs 

continue, consuH a w!ef'inaria!! immedi;tely by call!ng 1-8011-78t -me. How to open: Remove product tubes trom the ~. Separate ooe tube from the othen. Holding the lube with notched end pdntlng up &ld away IfOOl the tace and body, cut oN lhe narrow end al the notctles w~h scissors. 

How to apply: Invert tube OI'ef dog and use ope!! end to part dog's hair. Squeeze tube firmly to apply a~ 01 the solution to the dog's skin, as directed below. Repeat applicalioo may 00 made it necessary, OO! do not a~ more often than onct! ~ery 4 wooks. 

FREQUENCY OF APP~K:ATKlN 

Use Brand Y'M mOlithlylor complete COIltroi 01 1m, tick and chewing ke inlestations. Studies show that Brand Y'~ kills aduft fie,ru; tor up to three months. It your pet is at high risk lor I\ea reintestation, appty mOfithly. Ap~ monthly to control ticks, mosqu~oes, and chewing tce. Brnnd yrn kms mosquitoes witrun 24 hoofs lor tile first 7 days aftertreatment, then w1hin 48 hours tor up to 28 days. Brand Y"" remains eftective even aftll( bathing, water ill'l1lersion, 01 e};.posure to sunlight.JIJIow !reatoo area to dl'f thoroughly. 00 oot reapply tor 30 days. 

For Dogs Weighing Up to 22Ibs,: Apply one tube (U.B7 ml)(O.023 fl 01,\ I! you haw'! queslioos or COIIlments about this produc~ 

as a spol to the dog's back between the shou!der thdes. pleasa write: SENTRY Consumer Resp:lllse, 

U.S. and Foreign Patents Pendiflg 

Made In USA 

In Case of Emergency, call: t-8oo·781-4738 

Non-Emergency call t ..goo.224-PETS (7387) 

P.O. Box 540399, Omaha, NE 58t54·0399. 

Distributed by: Sergeant's Pet Care Products, Inc., 

P.O. Box 540399, Omaha, NE 6!1 t54-0399. 

EPA Reg. No.25t7-RUE 

EPA Est. No. 25tHN·j POOXXXX. ACRR 

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OF REACH OF CHILDREN 

WARNING 

See Ba<k label Panel for Additional Precautiooary Statements 

Net Contents: Three 0.023 II oz 

(0.67 mL) applicators 

KILLS 

"" fleas 

fA flea eggs 

~ticks 

Jr chewing lice 

~mosquitoes 

-'.- Controls mites that may cause sarcoptic mange 

• Waterproof 

ACTIVE tNGREDtENTS: 

Fipronil......... . .... 9.80% 

Cyphenothrin ................................ 5.20% 

(S)-melhoprene ........................... 8.80% 

OTHER INGREDIENTS~: ......... 76.40% 

TOTAL: ................................... 100.00%, 

'Diethylene Glycol Monoethyl Ether, 

Vitamin E Nicotinate 

EPA Reg # 2S17-RUE 

, 

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22
Front 

White tube I Blacktext on a white label I Colored Strip 

ART INSTRUCTION FOR THE PRINTER 

Printer/Vendor: 

- Additional Notes: BLACK 

Labels adhere to White Tubes 

38.1mm 

8mm 

--

10mm 

23
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fordogs 

KEEP OUT OF REACH OF CHILDREN 

WARNING 

KILLS 

'" fleas 

'41. flea eggs 

~ticks 

't chewing lice 

~mosquitoes 

-tf: Controls mites that may 

cause sarcoptic mange 

• Waterproof 

ACTIVE INGREDIENTS: 

Fipronil .......................................... 9.80% 

Cyphenothrin ................................ 5.20% 

{S)-methoprene ........................... 8.80% 

:R INGREOIENTS~: .... 76.40% 

'Oiethylene Glycol Monoethyl Ether, 

Vitamin E Nicotinate 

See Back label Panel for Additional Precautionary Statements c, c_=~--, 

Net Contents: Three 0.045 11 oz 

(1.34 mL) applicators 

24
Front 

White tube / Black text on a white label/Colored Strip 

ART INSTRUCTION FOR THE PRINTER 

--

Prinler/Vendor: 

BlACK PMS J6J Additional Notes: 

Labels adhere to White Tubes 

Dale sent: 

8mm 

--

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25
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SENTRY. 

Brand y

fordogs 

REACH OF CHILDREN 

ING 

Net Contents: Three 0.091 Iloz 

(2.68 mL) applicators 

KIL

'" flea

'I\. flea 

~ticks 

't chew

~mo5q

--. Contro

cause 

• Waterp

ACTIVE INGR

Fipronil...........

Cyphenothrin 

(S)-methopren

OTHER INGR

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

'Diethylene Gl

Vitamin E Nico

26
Front 

White tube I Black text on a white label I Colored Strip 

ART INSTRUCTION FOR THE PRINTER Printer/Vendor: 

--

BLACK PMS 200 Additional Notes: 

Labels adhere to White Tubes 

38,1mm 

Date sent: 

8mm 

--10mm 

27
o 

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SENTRY. 

Brand yTM 

fordogs 

IT". D.U" OF CHilDREN 

Net Contents: Three 0,136 II oz 

(4,02 mL) applicators 

KILLS 

'" fleas 

'4L flea eggs 

~ticks 

Jr chewing lice 

~mosquitoes 

,,~ Controls mites that may 

cause sa(coptic mange 

• Waterproof 

ACTIVE INGREDIENTS: 

Fipronil................... . ............... 9.80% 

Cyphenothrin ........ . ...... 5.20% 

(S)-methoprene ..... : ...................... 8.80% 

OTHER INGREDIENTS·; ........ 76.40% 

TOTAL: .................................... 100.00% 

*Diethylene Glycol Monoethyl Ether, 

Vitamin E Nicotinate 

28
Front 

White tube / Black text on a white label/Colored Strip 

ART INSTRUCTION FOR THE PRINTER 

--

SlACK PMS 2945 

Printer/Vendor: 

Additional Notes: 

Labels adhere to White Tubes 

38.1mm 

Date sent: 

8mm 

--

tomm 

29
BackTube Label 

KEEP OLIT OF REACH OFCHILDREN . WARNJN~: Read dir~ctions and prec3unons 

~~~~E~~I~~. ~~~7~~~orsP= 

ART INSTRUCTION FOR THE PRINTER Prinfer/Vendor: 

- Additional Notes: SLACK 

Labels adhere to White Tubes 

38.1mm 

Date sent: 

8mm 

--10mm 

30
31
ART INSTRUCTION FOR THE PRINTER 

Printer/Vendor: Dote sent: 

-- Additional Notes: BlACK PMS 2738 

3 

32
Tracking 

Create Resubmission 

u 

w~, 

t\. lJ\h(L-~~fY1 

33
DATA PACKAGE BEAN SHEET 

Date: 05·0ct·2010 

Page 1013 

••• Registration Information' •• 

Decision #: 438361 

DP #: (382788) 

PRIA 

Parent DP #: 

Submission #: 880182 

Registration: 2517·RUE· SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI \ Company: 2517 - SERGEANT'S PET CARE PRODUCTS, INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 S-7237 

Risk Manager Reviewer: Rosanna Louie RLOUIE 

Sent Date: ~~~~ Calculated Due Date: 23~Mar-2011 

Type of Registration: Product Registration - Section 3 

Edited Due Date: 

Action Desc: (R310) NEW PRODUCT;.i'l0N-FAST TRACK (INCLUDES REVIEWS OF P_RODUCT CHEMISl 

Ingredients: :oSe,..e ___ p"'a"'g-::;e-=3 ________________________ _ 

•• * Data Package Information * * * 

ExpedITe: 0 Yes. No Date Sent 05-0ct-2010 Due Back: 

DP Ingredient: ~~~~~~-See page 3 

DP Title: #2517-RUE: Product Chemistry R~-:v,,"ie.:.:w ______ _ 

CSF Included: • Yes 0 No Label Included: • Yes 0 No Parent DP #: --

~~~~ 

Assigned To Date In Date Out / 

Organization: -===- Last Possible Science Due Date: 21-Feb-2011 :.cRo:D-'-/-'T"Ro:B ________ ~ 

Team Name: c:C"H=E:.::M'---________ ~ 

Reviewer Name: ~ Q,lv'-A Mc,,--\-t~ 'L-.f I~ 

Contractor Name: 

* • * Studies Sent for Review' * * 

Printed on Page 2 

Science Due Date: 

Sub Data Package Due Date: ____ _ 

* * * Additional Data Package for this Decision * * * 

No Additional Data Packages 

• * • Data Package Instructions * * • 

Attn TRB/CHEM: Please conduct a product chemistry review of the attached package in support of the proposed product. Contact Rosanna 

Louie-Juzwiak at 308.0037 with any questions. 

Attachments: 

- cover letter 

- basic CSF 

- draft label 

- MRIDs 48189201, -02 

34
DATA EVALUATION RECORD 

FIPRONIL 

CYPHENOTHRIN 

S-METHOPRENE 

(Sergeant's Fipronil + Methoprene Squeeze-On for Dogs) 

STUDY TYPES: Product Identity and Composition (OPPTS 830.1550) 

Primary Reviewer: 

Description of Materials Used to Produce the Product (OPPTS 830.1600) 

Description of Production Process (830.1620) 

Discussion of Formation of Impurities (OPPTS 830.1670) 

Preliminary Analysis (OPPTS 830.1700) 

Certified Limits (OPPTS 830.1750) 

Enforcement Analytical Method (OPPTS 830.1800) 

Physical and Chemical Characteristics (OPPTS 830.6302-830.7950) 

MRlDs 481892-01 and 481892-02 

Prepared for 

Registration Division 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

One Potomac Yard 

2777 South Crystal Drive 

Arlington, V A 22202 

Prepared by 

Toxicology and Hazard Assessment Group 

Environmental Sciences Division 

Oak Ridge National Laboratory 

OakRidge, TN 37831 

Task Order No. 1-43 

Eric B. Lewis. M. S. Signature: 

Date: dAN 1 1 281 J 

Secondary Reviewers: 

Sylvia Milanez. Ph.D., D.A.B.T. Signature: 

Date: JAN 1 I 2011 

Robert H. Ross, M.S., Group Leader Signature: 

Date: 

Quality Assurance: 

Kimberly G. Slusher, M.S. Signature: 

Date: ,JAN 11 - " 

Disclaimer 

This review may have been altered subsequent to the contractor's signatures above. 

Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC., for the U.S. Department of Energy under 

Contract No. DE-ACOS-000R2272S. 

35
DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013. 129121. 105402; Action Code: R 310; FOOD Use: No 

DATE OUT: March 1. 2011 

SUBJECT: End Use Product Chemistry Review 

Product Name: Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs 

Shyam Mathur CAl) v~v'\--,. tfI .. "J,) . _~.. . Product Chemistry Team u\'p~ <'(/lD\ 1\ ~_ 

Technical Review Branch 1 Registration Division (7505P) Z> \ 

3j;r )11 

FROM: 

TO: Rosanna Louie 1 Richard Gebken, PM 10 

Insecticide Branch 1 Registration Division (7505P) 

Company Name: Sergeant's Pet Care Products, Inc. 

Formulation Type: Insecticide 

A. INTRODUCTION: 

The applicant submitted an application for registration of a new non-food use end use product. In support of 

the application, the applicant submitted product chemistry data corresponding to guideline 830 series, group 

A & group B (MRIDs 481892-01 and 481892-02). A CSF for a basic formulation (dated 8/11/2010) was 

submitted along with the product label. On the advice of the Agency, the registrant submitted a revised basic 

CSF and an alternate CSF #1 (both dated 02-28-11) bye-mail on February 28,2011. The primary review of 

the product chemistry data was performed by Oak Ridge National Laboratory, Oak Ridge, TN, USA.TRB has 

been asked to determine the acceptability of the product chemistry data and the proposed CSF's. 

B. SUMMARY OF FINDINGS: 

1. Name of Active Ingredient(s): Fipronil (9.8%), S-Methoprene (8.8%), Cyphenothrin (5.2%) 

2. All the source materials for the active ingredients are derived from registered sources: 

[Xl Yes; [l No 

3. All inert ingredients have been screened by IIAB and found to be approved for the proposed labeled uses 

[Xl Yes; [ 1 No. 

4. Confidential Statement of Formula(s): 

[Xl Basic - Dated: August 11, 2010; Re-submitted (email 02-28-11) - Dated: 28 February, 2011 

[Xl Alternate # 1 - Dated: 02-28-11 

Is the alternate CSF in compliance with 40CFR§152.43? 

[Xl Yes; [l No; [l NA 

2 

36

DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013. 129121. 105402; Action Code: R 310; FOOD Use: No 

DATE OUT: March 1. 2011 

SUBJECT: End Use Product Chemistry Review 

Product Name: Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs 

Shyam Mathur CAl) v~v'\--,. tfI .. "J,) . _~.. . Product Chemistry Team u\'p~ <'(/lD\ 1\ ~_ 

Technical Review Branch 1 Registration Division (7505P) Z> \ 

3j;r )11 

FROM: 

TO: Rosanna Louie 1 Richard Gebken, PM 10 

Insecticide Branch 1 Registration Division (7505P) 

Company Name: Sergeant's Pet Care Products, Inc. 

Formulation Type: Insecticide 

A. INTRODUCTION: 

The applicant submitted an application for registration of a new non-food use end use product. In support of 

the application, the applicant submitted product chemistry data corresponding to guideline 830 series, group 

A & group B (MRIDs 481892-01 and 481892-02). A CSF for a basic formulation (dated 8/11/2010) was 

submitted along with the product label. On the advice of the Agency, the registrant submitted a revised basic 

CSF and an alternate CSF #1 (both dated 02-28-11) bye-mail on February 28,2011. The primary review of 

the product chemistry data was performed by Oak Ridge National Laboratory, Oak Ridge, TN, USA.TRB has 

been asked to determine the acceptability of the product chemistry data and the proposed CSF's. 

B. SUMMARY OF FINDINGS: 

1. Name of Active Ingredient(s): Fipronil (9.8%), S-Methoprene (8.8%), Cyphenothrin (5.2%) 

2. All the source materials for the active ingredients are derived from registered sources: 

[Xl Yes; [l No 

3. All inert ingredients have been screened by IIAB and found to be approved for the proposed labeled uses 

[Xl Yes; [ 1 No. 

4. Confidential Statement of Formula(s): 

[Xl Basic - Dated: August 11, 2010; Re-submitted (email 02-28-11) - Dated: 28 February, 2011 

[Xl Alternate # 1 - Dated: 02-28-11 

Is the alternate CSF in compliance with 40CFR§152.43? 

[Xl Yes; [l No; [l NA 

2 
DP BARCODE No.: 0382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013, 129121, 105402; Action Code: R 310; FOOD Use: No 

5. Product label 

a. Ingredient statement: Nominal concentration of AI listed on CSF(s) concurs with product label 

(PR Notice 91-2) 

[Xl Yes, if not, explain below: 

Metallic equivalent: [ 1 Yes [Xl NA; 

Soluble arsenic: [l Yes [Xl NA 

Isomeric ratios: [l Yes [Xl NA 

Acid equivalent: [l Yes [Xl NA; {name} acid equivalent = xx % 

b. Health related sub statements: Product contains? 

Petroleum distillate at > 10%: 1 Yes [Xl No 1 NA 

Methanol at > 4%: 1 Yes [Xl No 1 NA 

c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for: 

fiammability, explosive potential or electric insulator breakdown? 

[ 1 Yes [Xl No 

Is the sub statement in compliance with PR Notice 97 -6? [ 1 Yes, [Xl NA; [ 1 No; if not, explain below: 

d. Label requires an additional Storage and Disposal statement: [ 1 Yes [Xl No; if yes explain below: 

3 

37

DP BARCODE No.: 0382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013, 129121, 105402; Action Code: R 310; FOOD Use: No 

5. Product label 

a. Ingredient statement: Nominal concentration of AI listed on CSF(s) concurs with product label 

(PR Notice 91-2) 

[Xl Yes, if not, explain below: 

Metallic equivalent: [ 1 Yes [Xl NA; 

Soluble arsenic: [l Yes [Xl NA 

Isomeric ratios: [l Yes [Xl NA 

Acid equivalent: [l Yes [Xl NA; {name} acid equivalent = xx % 

b. Health related sub statements: Product contains? 

Petroleum distillate at > 10%: [l Yes [Xl No [ 1 NA 

Methanol at > 4%: [ 1 Yes [Xl No [ 1 NA 

c. Physical chemical hazard statement: Product label requires a statement per 40 CFR §156.78 for: 

fiammability, explosive potential or electric insulator breakdown? 

[ 1 Yes [Xl No 

Is the sub statement in compliance with PR Notice 97 -6? [ 1 Yes, [Xl NA; [ 1 No; if not, explain below: 

d. Label requires an additional Storage and Disposal statement: [ 1 Yes [Xl No; if yes explain below: 

3 
DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013. 129121. 105402; Action Code: R 310; FOOD Use: No 

6. Group A: Product Chemistry Data 

TRB's determination of the acceptability of the data for the proposed product is listed in the tables below. 

Data submitted 

TRB's Guideline 

No. Study Title Assessment MRID Nos. 

Yes No 

of Data 

830.1550 Product Identity & Composition X A 481892-01 

Description of materials used to 

830.1600 produce the product X A 481892-01 

Description of formulation 

830.1650 process X A 481892-01 

Discussion on the formation of 

830.1670 impurities X A 481892-01 

830.1700 Preliminary analysis X NA 

Standard certified 

limits X A 

Certified 

limits Proposed Limits 481892-01 

(158.350) Justification for 

wider limits 

830.1750 

Enforcement analytical method 

830.1800 X G 

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver Request, I = In Progress, 

NA = Not Applicable 

4 

38
DP BARCODE No.: 0382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013. 129121.105402; Action Code: R 310; FOOD Use: No 

7. Group B: 

Guideline Study Title Value or Qualitative TRB's 

No. Description Assessment 

of Data 

830.6303 Physical State Liquid A 

830.6315 Flammability Flashpoint >90'C A 

Does not contain explosive 

830.6316 Explodability inQredients NA 

Not soluble/dispersible in 

830.7000 JlH water NA 

830.7300 Density (units) 1.00 - 1.05 g/cc A 

MRIDNos. 

481892-02 

481892-02 

481892-02 

481892-02 

481892-02 

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver request, NA = Not applicable, 

I = In progress 

5 

39
DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013. 129121, 105402; Action Code: R 310; FOOD Use: No 

C. CONCLUSIONS: 

The TRB has reviewed the CSF(s) and product chemistry data for the proposed end use product and has 

concluded: 

1. The proposed revised CSF for basic formulation (dated 02-28-11) and the new CSF for alternate 

formulation #1 (dated 02-28-11) are acceptable. 

2. The data submitted corresponding to guidelines 830.1600 (description of materials used to produce the 

product), 830.1650 (description of the formulation process), 830.1670 (discussion of the formation of 

impurifles), and 830.1750 (certified limits) are acceptable. 

3. No data was submitted for the guideline 830.1800 (enforcement analytical method), this was 

considered as a data gap. The registrant is advised to provide a validated enforcement analytical 

method for the determination of the three active ingredients in the proposed product. This is a product 

specific data and is required to satisfy the product chemistry data requirements. 

4. The product chemistry data submitted corresponding to guidelines 830.6302 (color), 830.6303 

(physical state), 830.6304 (odor), 830.6315 (flammability), 830.7100 (viscosity), and 830.7300 

(density) are acceptable. 

5. No data were submitted for guidelines 830.6317 (storage stability) and 830.6320 (corrosion 

characteristics), The registrant states that these data will be submitted when the studies are completed. 

It is recommended that the observations should be made at 0, 3,6, 9, and 12 month intervals. 

6. The proposed label was screened as it pertains to the product chemistry requirements. The final 

review of the proposed label and uses are the purview of the RM team. 

7. The registrant is advised to revise the Ingredient statement on the product label to correct the product 

label claim for the active ingredient cyphenothrin from 5.0% to 5.2%, so that it concurs with nominal 

concentration in the revised basic CSF (dated 02-28-11). 

6 

40

DP BARCODE No.: D382788; FILE SYMBOL No.: 2517-RUE; DECISION No.: 438361; 

PC Code(s): 129013. 129121, 105402; Action Code: R 310; FOOD Use: No 

C. CONCLUSIONS: 

The TRB has reviewed the CSF(s) and product chemistry data for the proposed end use product and has 

concluded: 

1. The proposed revised CSF for basic formulation (dated 02-28-11) and the new CSF for alternate 

formulation #1 (dated 02-28-11) are acceptable. 

2. The data submitted corresponding to guidelines 830.1600 (description of materials used to produce the 

product), 830.1650 (description of the formulation process), 830.1670 (discussion of the formation of 

impurifles), and 830.1750 (certified limits) are acceptable. 

3. No data was submitted for the guideline 830.1800 (enforcement analytical method), this was 

considered as a data gap. The registrant is advised to provide a validated enforcement analytical 

method for the determination of the three active ingredients in the proposed product. This is a product 

specific data and is required to satisfy the product chemistry data requirements. 

4. The product chemistry data submitted corresponding to guidelines 830.6302 (color), 830.6303 

(physical state), 830.6304 (odor), 830.6315 (flammability), 830.7100 (viscosity), and 830.7300 

(density) are acceptable. 

5. No data were submitted for guidelines 830.6317 (storage stability) and 830.6320 (corrosion 

characteristics), The registrant states that these data will be submitted when the studies are completed. 

It is recommended that the observations should be made at 0, 3,6, 9, and 12 month intervals. 

6. The proposed label was screened as it pertains to the product chemistry requirements. The final 

review of the proposed label and uses are the purview of the RM team. 

7. The registrant is advised to revise the Ingredient statement on the product label to correct the product 

label claim for the active ingredient cyphenothrin from 5.0% to 5.2%, so that it concurs with nominal 

concentration in the revised basic CSF (dated 02-28-11). 

6 
RE: 2517-RUE 

James Messina to: Shyam Mathur 02/28/2011 04:49 PM 

Shyam, 

Good point. We have spoken with the PM and are planning to send updated labels 

to them this week. 

Regards, 

Jim 

-----Original Message~----

From: Mathur.Shyam@epamail.epa.gov [mailto:Mathur.Shyam@epamail.epa.gov] 

Sent: Monday, February 28, 2011 3:50 PM 

To: James Messina 

Subject: Re: 2517~RUE 

Thanks James. You may have to revise the product label also for 

cyphenothrin to 5.2% and adjust the amounts of Other ingredients. 

shyam 

Shyam Mathur, Ph.D 

Product Chemistry Team Leader 

Technical Review Branch/Registration Division 

opp / USEPA 

703~308~9374 

From: 

To: 

Cc: 

Date: 

Subject: 

Shyarn, 

"James Messina rr <jrnessina@exponent.cotn> 

Shyam Mathur/DC/USEPA/US@EPA 

"Kelly Hoskins" <KHoskins@SERGEANTS.cotn>, "Matthew Feinberg n 

<mfeinberg@exponent.com>, IIPaulina Do" <pdo@exponent.cotn>, 

IIRyan Weidling" <rweidling@exponent.cotn> 

02/28/2011 03:36 PM 

2517~RUE 

As reqeusted today, please find attached updated CSF's (Basic and 

Alternate #1) for 2517-RUe (Sergeant's Fipronil + Cyphenothrin + 

Methoprene Squeeze-On for Dogs. We have separated the CSF into a Basic 

and Alternate #1 as per EPA policy. Additionally, we have updated the 

percentage of cyphenothrin from 5.0% to 5.2%. This change was already 

approved by EPA for 2517-140 and should also be acceptable for 2517~RUG. 

If you have any questions, please contact me. 

Best Regards, 

James Messina 

Senior Managing Regulatory Consultant 

Exponent 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 

41

RE: 2517-RUE 

James Messina to: Shyam Mathur 02/28/2011 04:49 PM ~~~~~~~~,~~,~~~~~,:~:~~~~,~,~~:~~~~,~~~~,~,~~~:~"~~"' .. '~""~'."~~'~~~.~".,.,~.,., .. ~ .. , .. ~. 

Shyam, 

Good point. We have spoken with the PM and are planning to send updated labels 

to them this week. 

Regards, 

Jim 

-----Original Message~----

From: Mathur.Shyam@epamail.epa.gov [mailto:Mathur.Shyam@epamail.epa.gov] 

Sent: Monday, February 28, 2011 3:50 PM 

To: James Messina 

Subject: Re: 2517~RUE 

Thanks James. You may have to revise the product label also for 

cyphenothrin to 5.2% and adjust the amounts of Other ingredients. 

shyam 

Shyam Mathur, Ph.D 

Product Chemistry Team Leader 

Technical Review Branch/Registration Division 

opp / USEPA 

703~308~9374 

From: 

To: 

Cc: 

Date: 

Subject: 

Shyarn, 

"James Messina rr <jrnessina@exponent.cotn> 

Shyam Mathur/DC/USEPA/US@EPA 

"Kelly Hoskins" <KHoskins@SERGEANTS.cotn>, "Matthew Feinberg n 

<mfeinberg@exponent.com>, IIPaulina Do" <pdo@exponent.cotn>, 

IIRyan Weidling" <rweidling@exponent.cotn> 

02/28/2011 03:36 PM 

2517~RUE 

As reqeusted today, please find attached updated CSF's (Basic and 

Alternate #1) for 2517~RUe (Sergeant's Fipronil + Cyphenothrin + 

Methoprene Squeeze-On for Dogs. We have separated the CSF into a Basic 

and Alternate #1 as per EPA policy. Additionally, we have updated the 

percentage of cyphenothrin from 5.0% to 5.2%. This change was already 

approved by EPA for 2517~140 and should also be acceptable for 2517~RUG. 

If you have any questions, please contact me. 

Best Regards, 

James Messina 

Senior Managing Regulatory Consultant 

Exponent 

Center for Chemical Regulation and Food Safety 

1150 Connecticut Avenue, N.W. 

Suite 1100 
DATA PACKAGE BEAN SHEET 

Date: 05-0ct-2010 

Page 1 of 3 

* * * Registration Information * * * 

Decision #: 438361 

DP #: (382790) 

PRIA 

Parent DP #: 

Submission #: 880182 

Registration: 2517-RUE - SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI 

Company: 25t7 - SERGEANT'S PET CARE PRODUCTS, INC .. _________ _ 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PYt S-7237 

Risk Manager Reviewer: :cR:.:c0s",accnccna=--=L:co~ui:.:ce-,-R=L=O-=UccIE,--______________ _ 

Sent Date: -'----- Calculated Due Date: 23-Mar-20 t t Edited Due Date: 

Type of Registration: Product Registration - Section 3 

Action Desc: (R31 0) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl 

Ingredients: "'S"ee=pa"'gc:e-=3'--________ _ 

* * * Data Package Information * * * 

Expedite: 0 Yes. No Date Sent: 05-0ct-2010 Due Back: 

DP Ingredient: See page 3 -~'-------

DP Title: #25t7-RUE Companion Animal Safety Review 

CSF Included: • Yes 0 No Label Included: • Yes 0 No Parent DP #: 

Assigned To Date In Date Out 

Organization: RD / TRS ----------

Team Name: TOX 

~~------------

Reviewer Name: --------

Contractor Name: -------------

* * * Studies Sent for Review * * * 

Printed on Page 2 

----

/ 

Last Possible SCience Due Date: 21-Feb-201 t / 

Science Due Date: ____ _ 

Sub Data Package Due Date: 

* * * Additional Data Package for this Decision * * * 

Can be printed on its own page 

* * * Data Package Instructions * * * 

Attn TRSrrOX: Please conduct a companion animal safety review of the attached package in support of the proposed product. Contact 

Rosanna Louje~Juzwiak at 308.0037 with any questions. 

Attachments; 

~ cover letter 

- basic CSF 

- draft label 

~ data matrix 

42
OP#: (382790) 

43121110 

43121111 

46166108 

43863802 

47849609 

43577711 

48129614 

43121111 

43121110 

43444905 

43863802 

Page 2 

* * * Studies Sent for Review * * * Decision#: (438361) 

Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab 

Project Number: 94423: PS-232DAS. Unpublished study 

prepared by White Eagle Toxicology Labs. 171 p. 

Arnaud, J.: Consalvi, P. (1993) Assessment of Tolerance of a 

0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 ml/kg 

When Applied 6 times to the Haircoat at 28 Day Intervals: 

Revised: Lab Project Number CLl138. Unpublished study 

prepared by Rhone Merieux, Inc. 69 p. 

Arnaud, J.: Consalvi, P. (1993) Domestic Animal Safety: 

Assessment of the Tolerance of a 0.25% RM 1601 Spray in 

Nursing Puppies Administered Twice at a 28 Day Interval at a 

Dose Rate of 6 ml/kg: Revised: Lab Project Number CLI 180. 

Unpublished study prepared by Rhone Merieux, Inc. 32 p. 

Kuhn, J. (2003) Companion Animal Safety Study in Dogs: 

Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project 

Number: 7650/03. Unpublished study prepared by Stillmeadow, 

Inc. and Miller, Thomas A. 53 p. 

Powell, L.; Pallett, R. (1995) Domestic Animal Safety study by 

Topical Administration to Dogs: Fipronil Spot Treatment (RM 

1601 E): Lab Project Number: MRX 23/950406. Unpublished 

study prepared by Huntingdon Research Centre, Ltd. 219 p. 

Delport, P. (2009) Companion Animal Safety Evaluation on Dogs 

of Spot-On Products Containing Multiple Toxicants and Insect 

Growth Regulators: Final Report. Project Number: 2517FEGEN, 

CV/08/551. Unpublished study prepared by Clin Vet Intemational. 

129 p. 

Walker, K. (1995) Discussion in Support of Bridging Domestic 

Animal Safety Data on Frontline Spray Treatment to Frontline 

Spot Treatment Data Package. Unpublished study prepared by 

Rhone Merieux, Inc. 6 p. 

Hoskins, K. (2010) Companion Animal Safety for Sergeant's 870.7200/Companion animal safety 

Fipronil + Cypheno1hrin Squeeze-On for Dogs. Project Number: 

SERGEANTS/06/10/06. Unpublished study prepared by 

Sergeant's Pet Care Products, Inc. 39 p. 

Arnaud, J.; Consalvi, P. (1993) Domestic Animal Safety: 870.7200/Companion animal safety 

Assessment of the Tolerance of a 0.25% RM 1601 Spray in 

Nursing Puppies Administered Twice at a 28 Day Interval at a 

Dose Rate of 6 ml/kg: Revised: Lab Project Number CLI 180. 

Unpublished study prepared by Rhone Merieux, Inc. 32 p. 

Arnaud, J.; Consalvi, P. (1993) Assessment of Tolerance of a 870.7200/Companion animal safety 

0.25% RM 1601 Spray Formulation in Dogs at 3,9, and 15 ml/kg 

When Applied 6 times to the Haircoat at 28 Day Intervals: 

Revised: Lab Project Number CLl138. Unpublished study 

prepared by Rhone Merieux, Inc. 69 p. 

Schwartz, E. (1994) Domestic Animal Safety Study of RM1601 C 870.7200/Companion animal safety 

Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab 

Project Number: 94423: PS-232DAS. Unpublished study 

prepared by White Eagle Toxicology Labs. 171 p. 

Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by 870.7200/Companion animal safety 

Topical Administration to Dogs: Fipronil Spot Treatment (RM 

1601 E): Lab Project Number: MRX 23/950406. Unpublished 

study prepared by Huntingdon Research Centre, Ltd. 219 p. 

43

OP#: (382790) 

43121110 

43121111 

46166108 

43863802 

47849609 

43577711 

48129614 

43121111 

43121110 

43444905 

43863802 

Page 2 

* * * Studies Sent for Review * * * Decision#: (438361) 

Topical Spray Spray Treatment) Dogs: Lab 

Project Number: 94423: PS-232DAS. Unpublished study 

prepared by White Eagle Toxicology Labs. 171 p. 

Arnaud, J.: Consalvi, P. (1993) Assessment of Tolerance of a 

0.25% RM 1601 Spray Formulation in Dogs at 3, 9, and 15 ml/kg 

When Applied 6 times to the Haircoat at 28 Day Intervals: 

Revised: Lab Project Number CLl138. Unpublished study 

prepared by Rhone Merieux, Inc. 69 p. 

Arnaud, J.: Consalvi, P. (1993) Domestic Animal Safety: 

Assessment of the Tolerance of a 0.25% RM 1601 Spray in 

Nursing Puppies Administered Twice at a 28 Day Interval at a 

Dose Rate of 6 ml/kg: Revised: Lab Project Number CLI 180. 

Unpublished study prepared by Rhone Merieux, Inc. 32 p. 

Kuhn, J. (2003) Companion Animal Safety Study in Dogs: 

Cyphenothrin-IGR Spot-on for Dogs: Final Report. Project 

Number: 7650/03. Unpublished study prepared by Stillmeadow, 

Inc. and Miller, Thomas A. 53 p. 

Powell, L.; Pallett, R. (1995) Domestic Animal Safety study by 

Topical Administration to Dogs: Fipronil Spot Treatment (RM 

1601 E): Lab Project Number: MRX 23/950406. Unpublished 

study prepared by Huntingdon Research Centre, Ltd. 219 p. 

Delport, P. (2009) Companion Animal Safety Evaluation on Dogs 

of Spot-On Products Containing Multiple Toxicants and Insect 

Growth Regulators: Final Report. Project Number: 2517FEGEN, 

CV/08/551. Unpublished study prepared by Clin Vet Intemational. 

129 p. 

Walker, K. (1995) Discussion in Support of Bridging Domestic 

Animal Safety Data on Frontline Spray Treatment to Frontline 

Spot Treatment Data Package. Unpublished study prepared by 

Rhone Merieux, Inc. 6 p. 

Hoskins, K. (2010) Companion Animal Safety for Sergeant's 870.7200/Companion animal safety 

Fipronil + Cypheno1hrin Squeeze-On for Dogs. Project Number: 

SERGEANTS/06/10/06. Unpublished study prepared by 

Sergeant's Pet Care Products, Inc. 39 p. 

Arnaud, J.; Consalvi, P. (1993) Domestic Animal Safety: 870.7200/Companion animal safety 

Assessment of the Tolerance of a 0.25% RM 1601 Spray in 

Nursing Puppies Administered Twice at a 28 Day Interval at a 

Dose Rate of 6 ml/kg: Revised: Lab Project Number eLi 180. 

Unpublished study prepared by Rhone Merieux, Inc. 32 p. 

Arnaud, J.; Consalvi, P. (1993) Assessment of Tolerance of a 870.7200/Companion animal safety 

0.25% RM 1601 Spray Formulation in Dogs at 3,9, and 15 ml/kg 

When Applied 6 times to the Haircoat at 28 Day Intervals: 

Revised: Lab Project Number CLl138. Unpublished study 

prepared by Rhone Merieux, Inc. 69 p. 

Schwartz, E. (1994) Domestic Animal Safety Study of RM1601 C 870.7200/Companion animal safety 

Topical Spray (Frontline Spray Treatment) in Juvenile Dogs: Lab 

Project Number: 94423: PS-232DAS. Unpublished study 

prepared by White Eagle Toxicology Labs. 171 p. 

Powell, L.; Paffett, R. (1995) Domestic Animal Safety Study by 870.7200/Companion animal safety 

Topical Administration to Dogs: Fipronil Spot Treatment (RM 

1601 E): Lab Project Number: MRX 23/950406. Unpublished 

study prepared by Huntingdon Research Centre, Ltd. 219 p. 
Page 3 

uP#: (382790) * * * Product and Data Package Ingredients * * * Decision#: (438361) 

1129121 1120068-37-3 Wipronil 

1129121 1120068-37-3 IFipronil(9.8%) 

1105402 ~5733-16-6 /S-Methoprene(8.8%) 

1129013 139515-40-7 ICyphenothrin(5%) 

44
DATA PACKAGE BEAN SHEET 

Date: 05-0ct-2010 

Page 1013 

* * * Registration Information * * * 

Decision #: 438361 

DP #: (382789) 

PRIA 

Parent DP #: 

Submission #: 880182 

Registration: 2517-RUE - SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI 

Company: 2517 - SERGEANT'S PET CARE PRODUCTS, INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 S-7237 

Risk Manager Reviewer: Rosanna Louie RLOUIE 

Sent Date: Calculated Due Da1e: 23-Mar-2011 ----

Type of Regis1ration: Produc1 Registration - Section 3 

Edited Due Da1e: 

Action Desc: (R310) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl 

Ingredients: S"e::;e:.'p'-'a""g':ce-'3 ____ ~ _______________________ _ 

* * * Data Package Information * * * 

Expedne: 0 Yes. No Date Sent: 05-0ct-2010 Due Back: 

DP Ingredient: "S"'ee::..c.Pa"g"e.c3'----__ . _____ _ 

DP Tnle: #2517-RUE Acule Toxicity Review 

CSF Included: • Yes 0 No Label Included: • Yes 0 No Parent DP #: ----

Assigned To Date In Date Out / 

Organization: :.:R~D-,-I.:.T~R:--B _____ ~ __ _ _____ Last Possible SCience Due Date: 21-Feb-2011 

T earn Name: TOX -------~ 

Science Due Da1e: ____ _ 

Reviewer Name: ________ _ Sub Data Package Due Da1e: _____ _ 

Contractor Name: __________ _ 

* * * Studies Sent for Review * * * 

Printed on Page 2 

* * * Additional Data Package for this Decision * * * 

Can be printed on ~s own page 

• * • Data Package Instructions' * • 

Attn TRBITOX: Please conduc1 an acute toxicity review of the attached package in support of the proposed product. Contact Rosanna 

Louie-Juzwiak at 308.0037 w~h any questions. 

Attachments: 

- cover letter 

- basic CSF 

- draft label 

- data matrix 

45
48129603 

48129608 

48129606 

48129607 

48129604 

48129605 

Page 2 

p. 

Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with 870.11 aD/Acute Oral Toxicity 

Dog Products (in Rats): Final Report. Project Number: 100137B. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 45 p. 

Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisation 870.2600/Skin sensitization 

Test) with Dog Products (in Guinea Pigs): Final Report. Project 

Number. 100141B. Unpublished study prepared by BSL 

Bioservice Scientific Laboratories Gmbh. 41 p. 

Ahuja, V. (2010) Acute Eye Irritation/Corrosion with Dog Products 870.2400/Acute eye irritation 

On Rabbits): Final Report. Project Number: 1001408. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 33 p. 

Ahuja, V. (2010) Acute Dermal Irritation/Corrosion with Dog 870.2500/Acute dermal irritation 

Products (in Rabbits): Final Report. Project Number: 100139B. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 29 p. 

Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog 870.1200/Acute dermal toxicity 

Products (in Rats): Final Report. Project Number: 100138B. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 34 p. 

Hoskins, K. (2010) Waiver Request of Requirement for Further 870.1300/Acute inhalation toxicity 

Testing for Acute Inhalation Toxicity for Following Sergeant's 

Products: Sergeant's Fipronil + Cyphenothrin Squeeze~On for 

Dogs, Sergeant's Fipronil + Cyphenothrin + Methoprene 

Squeeze~On for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar 

Squeeze~On for Dogs, Sergeant's Fipronil + Nylar Squeeze~On for 

Dogs, Sergeant's Fipronil + Etofenprox Spot~On for Cats, 

Sergeant's Fipronil + Etofenprox + Methoprene Spot~On for Cats, 

Sergeant's Fipronil + Etofenprox + Nylar Spot~On for Cats, 

Sergeant's Fipronil + Nylar Spot~On for Cats. Project Number: 

SERGEANTSI06110105. Unpublished study prepared by 

Sergeant's Pet Care Products, Inc. 6 p. 

46

48129603 

48129608 

48129606 

48129607 

48129604 

48129605 

Page 2 

p. 

Leoni, A. (2010) Acute Oral Toxicity Up and Down Procedure with 870.11 aD/Acute Oral Toxicity 

Dog Products (in Rats): Final Report. Project Number: 100137B. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 45 p. 

Stelter, D. (2010) Test for Sensitization (Guinea Pig Maximisation 870.2600/Skin sensitization 

Test) with Dog Products (in Guinea Pigs): Final Report. Project 

Number. 100141B. Unpublished study prepared by BSL 

Bioservice Scientific Laboratories Gmbh. 41 p. 

Ahuja, V. (2010) Acute Eye Irritation/Corrosion with Dog Products 870.2400/Acute eye irritation 

On Rabbits): Final Report. Project Number: 1001408. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 33 p. 

Ahuja, V. (2010) Acute Dermal Irritation/Corrosion with Dog 870.2500/Acute dermal irritation 

Products (in Rabbits): Final Report. Project Number: 100139B. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 29 p. 

Leoni, A. (2010) Acute Dermal Toxicity (Limit Test) with Dog 870.1200/Acute dermal toxicity 

Products (in Rats): Final Report. Project Number: 100138B. 

Unpublished study prepared by BSL Bioservice Scientific 

Laboratories Gmbh. 34 p. 

Hoskins, K. (2010) Waiver Request of Requirement for Further 870.1300/Acute inhalation toxicity 

Testing for Acute Inhalation Toxicity for Following Sergeant's 

Products: Sergeant's Fipronil + Cyphenothrin Squeeze~On for 

Dogs, Sergeant's Fipronil + Cyphenothrin + Methoprene 

Squeeze~On for Dogs, Sergeant's Fipronil + Cyphenothrin + Nylar 

Squeeze~On for Dogs, Sergeant's Fipronil + Nylar Squeeze~On for 

Dogs, Sergeant's Fipronil + Etofenprox Spot~On for Cats, 

Sergeant's Fipronil + Etofenprox + Methoprene Spot~On for Cats, 

Sergeant's Fipronil + Etofenprox + Nylar Spot~On for Cats, 

Sergeant's Fipronil + Nylar Spot~On for Cats. Project Number: 

SERGEANTSI06110105. Unpublished study prepared by 

Sergeant's Pet Care Products, Inc. 6 p. 
Page 3 

LlP#: (382789) * * .. Product and Data Package Ingredients "" .. Decision#: (438361) 

1120068-37-3 IFipronil 

1120068-37-3 IFipronil(9.8%) 

~5733-16-6 IS-Methoprene(8.8%) 

1129013 ~9515-40-7 ICyphenothrin(5%) 

47
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

February 15,2011 

MEMORANDUM 

Subject: Name of Pesticide Product: SERGEANT'S FIPRONIL + CYPHENOTHRIN 

+ METHOPRENE SQUEEZE-ON FOR DOGS 

EPA Reg. No. IFile Symbol: 2517-RUE 

DP Barcodes: DP 382789, 382790 

Decision No.: 438361 

Action Code: R310 

PC Codes: 129121 (Fipronil: 9.8%) 

129013 (Cyphenothrin: 5.0%) 

105402 (S-Methoprene: 8.8%) 

From: Byron T. Backus, Ph.D., Toxicologist n ~: (l -~-~Q-""I Technical Review Branch f <L-'" -l5' - 1.-<> \. \ r/IJ _ 0 "-

Registration Division (7505P) l ~ 

To: Rosanna Loiue-JuzwiaklRichard Gebken RM 10 

Insecticide Branch 

Registration Division (7505P) 

Registrant: SERGEANT'S PET CARE PRODUCTS, INC. 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

129121 Fipronil 

129013 Cyphenothrin 

105402 (S)-methoprene 

Other Ingredient(s): 

TOTAL 

ACTION REQUESTED: The Risk Manager requests: 

bywt. 

9.8% 

5.0% 

8.8% 

76.4% 

100.0% 

For DP 382789: " ... Please conduct an acute toxicity review ofthe attached package in support of 

the proposed product. .. " 

Pagelof4 

48
For DP 382790: " ... Please conduct a companion animal safety review of the attached package in 

support of the proposed product ... " 

BACKGROUND: 

The material received for review includes a data matrix, a CSF (dated 8111120 I 0) and a proposed 

label for this product, indicating use on adult dogs and puppies 12 weeks old and older. 

COMMENTS AND RECOMMENDATIONS: 

1. The five cited acute toxicity studies (48129603, 48129604, 48129606 - 48129608) were 

conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene 

(8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as 

acceptable (TRB memorandum dated November 23, 2010 for 2517-RUN), and can be used to 

support the registration of 25l7-RUE. The signal word is WARNING, based on the eye 

irritation potential (MRID 48129606). 

2. The material in the inhalation waiver request in MRID 48129605 is applicable to 2517-RUE. 

Refer to the TRB memorandum dated November 23, 2010 for 2517-RUN which states: "Based 

on the amount offormulation applied (0.5-4.5 mL), the packaging of these products (single-use 

containers or ampoules), the non-volatile nature of the formulations, and the application method 

(directly to the skin of the dog or cat) which does not result in any respirable particles, TRB 

concludes that a waiver for the acute inhalation study requirement is appropriate, and that these 

products can be assigned to EPA Toxicity Category IV by this exposure route." 

3. The proposed label dosage rates for 2517-RUE are 0.67 mL for dogs up to 22 lbs; 1.34 mL 

for dogs 23-44 lbs; 2.68 mL for dogs 45-88 lbs; and 4.02 mL for dogs 89-132 lbs. The cited 

companion animal safety studies include MRID 47849609, in which six Group A2 puppies were 

treated with 5 applications of substance IA (containing 8.2% cyphenothrin and 9.8% fipronil) 

and 5 applications of substance II (55.16% etofenprox, 8.78% methoprene and 2.31 % 

pyriproxyfen). The mean total dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and 

6.88 (range: 6.69-7.05) mLlkg for substance II. Group B2 adults were treated with 5 applications 

of substance IA and 5 applications of substance III (8.90% methoprene, 2.43% pyriproxyfen). 

The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance IA and 0.395 (range: 

0.352-0.443) mLlkg for substance III. The proposed label dosage rates for 2517-RUE are 0.67 

mL for dogs up to 22 lbs; 1.34 mL for dogs 23-44 lbs, 2.68 mL for dogs 45-88 lbs; and 4.02 mL 

for dogs 89-132 lbs. Assuming that the test substances and proposed product have a specific 

gravity = 1.0, the puppies were treated with means of 151 mg cyphenothrinlkg, 180 mg 

fipronil/kg, and 604 mg methoprene/kg. Dividing these values by 5 would give 30.2 mg 

cyphenothrinlkg, 36 mg fipronil/kg and 120.8 mg methoprene/kg. In terms of the formulation 

for 2517-RUE these values would be 0.604, 0.367, and 13.73 mLlkg, respectively, indicating that 

0.67 mL would be acceptable for puppies weighing 1.83 (0.67 mL divided by 0.367 mLlkg) kg 

or more. 1.83 kg is 4.03 lb, so (applying a 5X safety factor) we can accept the data for dogs 

weighing 4 pounds or more. The cited companion animal safety studies adequately support the 

use of this product on dogs and puppies 12 weeks old or older. Labeling should indicate a 

minimum weight of 4 Ibs for dogs or puppies. 

Page2of4 

49

For DP 382790: " ... Please conduct a companion animal safety review of the attached package in 

support of the proposed product ... " 

BACKGROUND: 

The material received for review includes a data matrix, a CSF (dated 8111120 I 0) and a proposed 

label for this product, indicating use on adult dogs and puppies 12 weeks old and older. 

COMMENTS AND RECOMMENDATIONS: 

1. The five cited acute toxicity studies (48129603, 48129604, 48129606 - 48129608) were 

conducted on a formulation containing as active ingredients: Fipronil (9.8%), (S)-Methoprene 

(8.5%), Cyphenothrin (5.5%) and Pyriproxyfen (2%). The studies were previously classified as 

acceptable (TRB memorandum dated November 23, 2010 for 2517-RUN), and can be used to 

support the registration of 25l7-RUE. The signal word is WARNING, based on the eye 

irritation potential (MRID 48129606). 

2. The material in the inhalation waiver request in MRID 48129605 is applicable to 2517-RUE. 

Refer to the TRB memorandum dated November 23, 2010 for 2517-RUN which states: "Based 

on the amount offormulation applied (0.5-4.5 mL), the packaging of these products (single-use 

containers or ampoules), the non-volatile nature of the formulations, and the application method 

(directly to the skin of the dog or cat) which does not result in any respirable particles, TRB 

concludes that a waiver for the acute inhalation study requirement is appropriate, and that these 

products can be assigned to EPA Toxicity Category IV by this exposure route." 

3. The proposed label dosage rates for 2517-RUE are 0.67 mL for dogs up to 22 lbs; 1.34 mL 

for dogs 23-44 lbs; 2.68 mL for dogs 45-88 lbs; and 4.02 mL for dogs 89-132 lbs. The cited 

companion animal safety studies include MRID 47849609, in which six Group A2 puppies were 

treated with 5 applications of substance IA (containing 8.2% cyphenothrin and 9.8% fipronil) 

and 5 applications of substance II (55.16% etofenprox, 8.78% methoprene and 2.31 % 

pyriproxyfen). The mean total dose was 1.84 (range: 1.79-1.88) mLlkg for test substance IA and 

6.88 (range: 6.69-7.05) mLlkg for substance II. Group B2 adults were treated with 5 applications 

of substance IA and 5 applications of substance III (8.90% methoprene, 2.43% pyriproxyfen). 

The mean total dose was 0.395 (range: 0.352-0.443) mLlkg for substance IA and 0.395 (range: 

0.352-0.443) mLlkg for substance III. The proposed label dosage rates for 2517-RUE are 0.67 

mL for dogs up to 22 lbs; 1.34 mL for dogs 23-44 lbs, 2.68 mL for dogs 45-88 lbs; and 4.02 mL 

for dogs 89-132 lbs. Assuming that the test substances and proposed product have a specific 

gravity = 1.0, the puppies were treated with means of 151 mg cyphenothrinlkg, 180 mg 

fipronil/kg, and 604 mg methoprene/kg. Dividing these values by 5 would give 30.2 mg 

cyphenothrinlkg, 36 mg fipronil/kg and 120.8 mg methoprene/kg. In terms of the formulation 

for 2517-RUE these values would be 0.604, 0.367, and 13.73 mLlkg, respectively, indicating that 

0.67 mL would be acceptable for puppies weighing 1.83 (0.67 mL divided by 0.367 mLlkg) kg 

or more. 1.83 kg is 4.03 lb, so (applying a 5X safety factor) we can accept the data for dogs 

weighing 4 pounds or more. The cited companion animal safety studies adequately support the 

use of this product on dogs and puppies 12 weeks old or older. Labeling should indicate a 

minimum weight of 4 Ibs for dogs or puppies. 

Page2of4 
4. The following is the acute toxicity profile for Sergeant's Fipronil + Cyphenothrin + 

Methoprene Squeeze-On for Dogs (EPA File Symbol 25 I 7-RUE), based on the results of the 

acute toxicity studies: 

Acute oral toxicity III Cited MRID 48129603 

Acute dermal toxicity III Cited MRID 48129604 

Acute inhalation toxicity (IV) Waived (MRID 48129605) 

Primary eye irritation II Cited MRID 48129606 

Primary dermal irritation IV Cited MRID 48129607 

Dermal sensitization Positive Cited MRID 48129608 

5. Based on the acute toxicity profile above, and taking into consideration the proposed uses 

specified on the label and information in the CSF, the following would be the precautionary and 

first aid labeling for EPA File Symbol 2517-RUN [Sergeant's Fipronil + Cyphenothrin SqueezeOn for Dogs] as obtained from the Label Review System: 

PRODUCT ID #: 002517-00142 

PRODUCT NAME: SERGEANT'S FIPRONIL + CYPHENOTHRIN SQUEEZE-ON FOR DOGS 

PRECAUTIONARY STATEMENTS 

SIGNAL WORD: WARNING 

Hazards to Humans and Domestic Animals: 

Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators 

or persons under their direct supervision and only for those uses covered by the Certified Applicator's 

certification. Child Resistant Packaging Required. 

Causes substantial but temporary eye injury. Harmful if absorbed through skin. Harmful if swallowed. Do 

not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash 

thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using 

tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear longsleeved shirt and long pants, socks, shoes, and gloves. 

Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. 

First Aid: 

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. 

-Call a poison control center or doctor for treatment advice. 

If on skin: 

-Take off contaminated clothing. 

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

-Call a poison control center or doctor for treatment advice. 

If swallowed: 

-Call a poison control center or doctor immediately for treatment advice. 

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

Page 3 of4 

50

4. The following is the acute toxicity profile for Sergeant's Fipronil + Cyphenothrin + 

Methoprene Squeeze-On for Dogs (EPA File Symbol 25 I 7-RUE), based on the results of the 

acute toxicity studies: 

Acute oral toxicity III Cited MRID 48129603 

Acute dermal toxicity III Cited MRID 48129604 

Acute inhalation toxicity (IV) Waived (MRID 48129605) 

Primary eye irritation II Cited MRID 48129606 

Primary dermal irritation IV Cited MRID 48129607 

Dermal sensitization Positive Cited MRID 48129608 

5. Based on the acute toxicity profile above, and taking into consideration the proposed uses 

specified on the label and information in the CSF, the following would be the precautionary and 

first aid labeling for EPA File Symbol 2517-RUN [Sergeant's Fipronil + Cyphenothrin SqueezeOn for Dogs] as obtained from the Label Review System: 

PRODUCT ID #: 002517-00142 

PRODUCT NAME: SERGEANT'S FIPRONIL + CYPHENOTHRIN SQUEEZE-ON FOR DOGS 

PRECAUTIONARY STATEMENTS 

SIGNAL WORD: WARNING 

Hazards to Humans and Domestic Animals: 

Restricted Use Pesticide due to toxicity categories. For retail sale to and use only by Certified Applicators 

or persons under their direct supervision and only for those uses covered by the Certified Applicator's 

certification. Child Resistant Packaging Required. 

Causes substantial but temporary eye injury. Harmful if absorbed through skin. Harmful if swallowed. Do 

not get in eyes or on clothing. Wear protective eyewear (goggles, face shield, or safety glasses). Wash 

thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using 

tobacco. Remove and wash contaminated clothing before reuse. Avoid contact with skin. Wear longsleeved shirt and long pants, socks, shoes, and gloves. 

Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. 

First Aid: 

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. 

-Call a poison control center or doctor for treatment advice. 

If on skin: 

-Take off contaminated clothing. 

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

-Call a poison control center or doctor for treatment advice. 

If swallowed: 

-Call a poison control center or doctor immediately for treatment advice. 

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

Page 3 of4 
-Do not induce vomiting unless told to by a poison control center or doctor. 

-Do not give anything to an unconscious person. 

NOTE TO PHYSICIAN: Note to PM/CRM/Registrant: The proposed label should contain a "Note to 

Physician". The following statements are suggested types of information that may be included, if 

applicable: - technical information on symptomatology; - use of supportive treatments to maintain life 

functions; - medicine that will counteract the specific physiological effects of the pesticide; - company 

telephone number to specific medical personnel who can provide specialized medical advice. 

Have the product container or label with you when calling a poison control center or doctor or going for 

treatment. You may also contact 1-800-xxx-xxxx for emergency medical treatment information. 

According to the LRS, this product is a candidate for restricted use because it is in Toxicity 

Category II for eye exposure. However, TRB concludes that, based on the packaging (in 

ampules) and proposed product use (direct application to the skin of dogs or cats), the risk of eye 

exposure is adequately reduced, and a restricted use classification is not necessary. 

6. The CSF (dated 8/11/2010) for 2517 -RUE should also be reviewed and accepted by the TRB 

Chemistry Team. 

Page 4 of4 

51

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

-Do not give anything to an unconscious person. 

NOTE TO PHYSICIAN: Note to PM/CRM/Registrant: The proposed label should contain a "Note to 

Physician". The following statements are suggested types of information that may be included, if 

applicable: - technical information on symptomatology; - use of supportive treatments to maintain life 

functions; - medicine that will counteract the specific physiological effects of the pesticide; - company 

telephone number to specific medical personnel who can provide specialized medical advice. 

Have the product container or label with you when calling a poison control center or doctor or going for 

treatment. You may also contact 1-800-xxx-xxxx for emergency medical treatment information. 

According to the LRS, this product is a candidate for restricted use because it is in Toxicity 

Category II for eye exposure. However, TRB concludes that, based on the packaging (in 

ampules) and proposed product use (direct application to the skin of dogs or cats), the risk of eye 

exposure is adequately reduced, and a restricted use classification is not necessary. 

6. The CSF (dated 8/11/2010) for 2517 -RUE should also be reviewed and accepted by the TRB 

Chemistry Team. 

Page 4 of4 
DATA PACKAGE BEAN SHEET 

Date: 05-0ct-2010 

Page 1013 

* * * Registration Information * * * 

Decision #: 438361 

DP #: (382791) 

PRIA 

Parent DP #: 

Submission #: 880182 

Registration: 2517-RUE - SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI 

Company: 2517 - SERGEANT'S PET CARE PRODUCTS, INC. 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# PY1 S-7237 

Risk Manager Reviewer: "R"'os:"a."n'"na"-'=L:"o':"ui"e"R'":L"O':'U .. IE'-__________ ~ ___ _ 

Sent Date: _~ __ _ Calculated Due Date: 23-Mar-2011 Edited Due Date: 

Type of Registration: Product Registration - Section 3 

Action Desc: (R310) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl 

Ingredients: ~S"ee"J:'Pa"'g!"e,,3'--_______________________ ~ 

* * * Data Package Information * * * 

Expedite: 0 Yes. No Date Sent: 05-0ct-2010 Due Sack: 

DP Ingredient: ~S":ee"J:'pa",g!,,e,,3,--____ _ 

DP Title: #2517-RUE: CRP Review 

CSF Included: • Yes 0 No Label Included: • Yes 0 No Parent DP #: __ _ 

Date In Date Out 

Organization: ':R":D"I-'T"R":B'--______ ~ ~'3 \ \ 0 Last Possible Science Due Date: 21-Feb-2011 

Team Name: Child Resistant Packaging Science Due Date: 

Reviewer Name: __________ ~ Sub Data Package Due Date: 

Contractor Name: __________ ~ 

* * * Studies Sent for Review * * * 

Printed on Page 2 

* * * Additional Data Package for this Decision * * * 

Can be printed on its own page 

* * * Data Package Instructions * * * 

Attn TRB/CRP: Please conduct a CRP Packaging review of the attached package in support of the proposed product. Contact Rosanna 

Louie-Juzwiak at 308.0037 with any questions. 

Attachments: 

- cover letter 

-letter for CRP certification (including cited studies) 

-letter for CRP information 

- basic CSF 

- draft label 

- data matrix 

NOTE: with regards to CRP review, there is no greater toxicity from cyphenothrin or s-methoprene exposure (i.e., does not trigger need for CRP) 

that would exceed that of fipronil. 

52
DP#: (382791) 

48059804 

48059805 

48059806 

Page 2 

* * * Studies Sent for Review *,. * 

Dog Squeeze on 

Applicator with Orange Label Indicator (3x), Scissors to Open 

F=1 as a Poison Prevention Package for Sergeant's Pet Care 

Products, Inc.: Final Report. Project Number: 1746/002. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Ward, R. (2010) Evaluation olthe Dog Squeeze on 1.34ml White 

Applicator with Green Label Indicator (3x), Scissors to Open ~ F= t 

as a Poison Prevention Package for Sergeant's Pet Care 

Products, Inc.: Final Report. Project Number: t746/003. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Ward, R. (2010) Evaluation of the Dog Squeeze on 2.68ml White 

Applicator with Red Label Indicator (3x). Scissors to Open ~ F=1 

as a Poison Prevention Package for Sergeant's Pet Care 

Products. Inc.: Final Report. Project Number: t746/004. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Ward, R. (2010) Evaluation 01 the Dog Squeeze on 4.02ml Whtte 

Applicator with Blue Label Indicator (3x), Scissors to Open F= t 

as a Poison Prevention Package for Sergeant's Pet Care 

Products, Inc.: Final Report. Project Number: 1746/005. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Decision#: (43836t) 

~ 

53

DP#: (382791) 

48059804 

48059805 

48059806 

Page 2 

* * * Studies Sent for Review *,. * 

Dog Squeeze on 

Applicator with Label Indicator (3x), Scissors to Open 

F=1 as a Poison Prevention Package for Sergeant's Pet Care 

Products, Inc.: Final Report. Project Number: 1746/002. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Ward, R. (2010) Evaluation olthe Dog Squeeze on 1.34ml White 

Applicator with Green Label Indicator (3x), Scissors to Open ~ F= t 

as a Poison Prevention Package for Sergeant's Pet Care 

Products, Inc.: Final Report. Project Number: t746/003. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Ward, R. (2010) Evaluation of the Dog Squeeze on 2.68ml White 

Applicator with Red Label Indicator (3x). Scissors to Open ~ F=1 

as a Poison Prevention Package for Sergeant's Pet Care 

Products. Inc.: Final Report. Project Number: t746/004. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Ward, R. (2010) Evaluation 01 the Dog Squeeze on 4.02ml Whtte 

Applicator with Blue Label Indicator (3x), Scissors to Open F= t 

as a Poison Prevention Package for Sergeant's Pet Care 

Products, Inc.: Final Report. Project Number: 1746/005. 

Unpublished study prepared by Perritt Laboratories, Inc. 28 p. 

Decision#: (43836t) 

~ 
Page 3 

DP#: (382791) * * * Product and Data Package Ingredients * * * Decision#: (438361) 

1129013 139515-40-7 ICyphenothrin 

1129121 1120068~37~3 IFipronil 

1129121 1120068-37-3 IFipronil(9.8%) 

1105402 ~5733-16-6 is-Methoprene(8.8%) 

1129013 139515-40-7 iCyphenothrin(5%) 

54
;'\y-D S7."'1,€ 

::fi'a' "\;, !P ~J :n "!! '" q;' 't . .{ ~ A' V~';i. pR01~ 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20-160 

NOTE TO RM 10 Rosanna Louie-Juzwiak 

OFFICl~ OF CHI<:l\IICAL SAFETY 

.-\1'H} POLLFfJON PREYENTJON 

December 23,2010 

SUBJECT: Certification to Compliance with Child-Resistant Packaging Regulations 

EPA FILE NO: 2517-RUE, DP 382791, Decision # 438361 

The August 11, 2010 CRP certification and bridging letter (indicating the same size 

and color package as package tested) for EPA Registration No. 2517-RUE are 

acceptable. The August 11, 2010 label for EPA Registration No. 2517-RUE has the 

same CRP directions as were used in the CRP testing. 

All the requirements for CRP have been met for EPA Registration No. 2517-

RUE. The directions on opening the package given to consumers must be identical 

to those given to the seniors during testing. 

Should any human experience/epidemiological evidence indicate a problem once 

the product is in the marketplace, the Agency reserves the right to reexamine this data 

comprehensively and to question the child resistance of the package involved. 

Thank you for your cooperation in this matter. If you have any questions please 

contact me at (703)-308-7368. 

~~J/~ 

Rosalind L. Gross 

55

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20-160 

NOTE TO RM 10 Rosanna Louie-Juzwiak 

OFFICl~ OF CHI<:l\IICAL SAFETY 

.-\1'H} POLLFfJON PREYENTJON 

December 23,2010 

SUBJECT: Certification to Compliance with Child-Resistant Packaging Regulations 

EPA FILE NO: 2517-RUE, DP 382791, Decision # 438361 

The August 11, 2010 CRP certification and bridging letter (indicating the same size 

and color package as package tested) for EPA Registration No. 2517-RUE are 

acceptable. The August 11, 2010 label for EPA Registration No. 2517-RUE has the 

same CRP directions as were used in the CRP testing. 

All the requirements for CRP have been met for EPA Registration No. 2517-

RUE. The directions on opening the package given to consumers must be identical 

to those given to the seniors during testing. 

Should any human experience/epidemiological evidence indicate a problem once 

the product is in the marketplace, the Agency reserves the right to reexamine this data 

comprehensively and to question the child resistance of the package involved. 

Thank you for your cooperation in this matter. If you have any questions please 

contact me at (703)-308-7368. 

Rosalind L. Gross 
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

August 11,2010 

Richard Gebken, PMIO 

Office ofpesticide Programs (7504P) 

u.s. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Certification 

Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs 

EPA File Symbol 25 I 7-NEW R-v-fC 

Dear Mr. Gebken: 

I certify that the packaging used for the following product meets the standards of 40 CFR 157.32, 

including the revised standards in 16 CFR 1700.15(b), when tested by the revised testing 

procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21,1995): 

• Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs (EPA File 

Symbo12517~ 

~J)E. 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th Plaza, Omal1a, NE 68130-1770, 

EPA Company Number 2517) is submitting this child resistant packaging certification to support 

for the new end-use product for Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On 

for Dogs (EPA File Symbol 25 I 7-NEW). All product labels have language specifying the use of 

scissors to open the product container and label language stating the product is not to be applied 

by children. 

If you have any questions, please contact me at 402-938-7079. 

Sincerely, 

J21b 'e. t-l% ~ ! btl K~ll; R~oskins Manager of Technical Affairs 

cc: Larry Nouvel 

56
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha. NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com 

August 11,2010 

Rosalind Gross 

c/o Richard Gebken 

Registration Division 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Support 

Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs (EPA 

File Symbol: 2517-NfiW) (Zv.-"" 

Dear Ms. Gross: 

Sergeant's Pet Care Products, Inc. (EPA Company Number 2517) is submitting a request to rely 

on previously submitted Child Resistant Packaging (CRP) studies to support this new 

registration. The CRP data were submitted to EPA on April 12, 20 lOin support of the pending 

registration applications under EPA File Symbols: 2517-RGT, 2517-RGA, 2517-RGL, and 

2517-RGU (all of which contain Fipronil at 9.7-9.8%). 

Sergeant's generated CRP data on a standard white applicator in sizes 0.5, 0.67, 1.34,2.68, and 

4.02 mL. The following is a sununary table of the applicators that were tested and submitted to 

EPA in the CRP data: 

Use Applicator Base Color Fill Weight (mL) Color 

Dog Up to 22 Ibs White 0.67 Orange V 

Dog 23-44 Ibs White 1.34 Green V 

Dog 45-88 Ibs White 2.68 Red V 

Dog 89-132 Ibs White 4.02 . Blue V 

Cats All Weigbts White 0.50 Purple \/ 

CRP data is required for this new product because of the inclusion of the active ingredient 

fipronil (9.8%) in the pet squeeze-on product. The CRP testing was conducted on a standard 

package size and color configuration for a product containing fipronil (9.8%). The Sergeant's 

Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs product being submitted today also 

contains fipronil at 9.8%. Additionally, Sergeant's already has dog squeeze-on products 

approved by EPA containing 20-30% cyphenothrin (EPA Registration Numbers 2517-127 

through 2517-132) that are not subject to CRP. This new product contains 5% cyphenothrin and 

1 

57
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

8.8 % methoprene. Additionally, there are EPA registered products containing s-methoprene, 

none of which are subject to CRP. 

Furthermore, Sergeant's does not anticipate any additional toxicity through the combination of 

fipronil, cyphenothrin and methoprene. When Sergeant's Fipronil + Cyphenothrin + Methoprene 

Squeeze-On for Dogs is marketed, it will have the same applicator color (white) and fill weight 

colors per mL fill weight as was used in the submitted and referenced CRP testing. Based on 

available information, the density range of the pending products on which the CRP data were 

generated is the sarqe as t~1 new prod1!9t (1.0-1.5 gr/J;c). Therefore, Sergeant's is relying on 

MRID's: 4805980)1, 48059804, 480598'05, and 480~9806 to fulfill the CRP data requirements 

for Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs. 

If you have any questions, please contact me at 402-938-7079. 

Sincerely, 

~ '8-. ~glu0-:) ! C-~T Kelly R. Hoskins 

Manager of Technical Affairs 

cc: Larry Nouvel 

2 

58
DATA PACKAGE BEAN SHEET 

Date: 05-0ct-2010 

Page 1 of 3 

* * * Registration Information * * * 

Decision #: 438361 

DP #: (382792) 

PRIA 

Parent DP #: 

Submission #: 880182 

Registration: 2517-RUE - SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENI 

Company: 251<7 - SERGEANT'S PET CARE PRODUCTS, INC< 

Risk Manager: RM 10 - Richard Gebken - (703) 305-6701 Room# Pyt S-7237 

Risk Manager Reviewer: :.:Rc::os::.:a::cn",n~a-=L"o=ui:::e-,-R::::L:::O=U~IE=---____________ ~ ___ _ 

Sent Date: Calculated Due Date: 23-Mar-2011 Edited Due Date: ____ ~ 

Type of Registration: Product Registration - Section 3 

Action Desc: (R310) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl 

Ingredients: ::S"-ee=--"'pa::;g"e-=3'-_____ ~ ____________________ _ 

* * * Data Package Information * * * 

Expedite: 0 Yes. No Date Sent: 05-0ct-2010 Due Back: ----

DP I ngredient: See page 3 -~~---------------------

DP Title: #2517-RUE: Efficacy Review 

CSF Included: 0 Yes. No Label Included: • Yes 0 No Parent DP #: ----

Assigned To Date In Date Out 

Organization: "R:::D.:.'-.:Tc.R:::B _______ _ _ ____ Last Possible Science Due Date: 21-Feb-2011 

Team Name: ::E:::ffi:::ca"'c"y..;("'IB:!.) ______ _ Science Due Date: ----

Reviewer Name: --------- Sub Data Package Due Date: 

Contractor Name: ---------

•• • Studies Sent for Review * * • 

Printed on Page 2 

** * Additional Data Package for this Decision • • * 

Can be printed on its own page 

* * • Data Package Instructions • • • 

Attn Efficacy Reviewer: Please conduct an efficacy review of the attached package in support of the proposed product. Contact Rosanna 

Louie-Juzwiak at 308.0037 with any questions. 

Attachments: 

- cover letter 

- draft label 

- data matrix (; ('1/ 

\ 

'D , ( 

59
DP#: (382792) 

43121114 

45612701 

46298501 

43121115 

43121116 

48129610 

43121117 

45620505 

48189203 

48129611 

43121118 

45620504 

45866902 

Page 2 

* * * Studies Sent for Review * * * 

Frontline Top Spot, and IVlL.-<,U",',."O 

the and Control of Trichodectes canis in the Dog: 

Report: Lab Project Number: PR&D 0022101, PR&D 00221. 

Unpublished study prepared by Centro Veterinario Oriola. 24 p. 

{OPPTS 810.3300} 

Everett, R.; Cunningham, J. (1993) A Dose Titration Study to 

Determine the Optimal Spray Concentration of RM 1601 for Long 

Term Control of the Cat Flea Ctenocephalides felis and the Brown 

Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab 

Project Number: RMD 292: P/214LT. Unpublished study prepared 

by Agresearch Consultants. 53 p. 

Ahmed, Z. (2002) Study Summaries: Frontline Plus For Dogs. 

Unpublished study prepared by Merial. 40 p. 

Miller, T. (2003) Effect of Shampoo After Treatment with 

Cyphenothrin Squeeze-on on Efficacy against Adult Cat Flease 

(Ctenocephalides felis), Adutt Brown Ticks (Rhipicephalus 

saguineus) on Dogs: Analysis of Data and Conclusions. Project 

Number: MS/20D. Unpublished study prepared by Sharp 

Veterinary Hospital and Vetoquinol N.A., Inc. 15 p, 

Cruthers, L. (1993) Product Performance: A Dose Confirmation 

Study to Verify the Optimal Spray Concentration of RM 1601 for 

Long Residual Control of the Cat Flea (Ctenocephalides felis) and 

the Brown Dog Tick (Rhipicephalus sanguine us) in the Dog: 

Revised: Lab Project Number: 9251: P/215LT. Unpublished study 

prepared by Professional Labs and Research Services, Inc. 51 

p. 

Everett, R; Cunningham, J. (1993) A Comparative Evaluation of 

Two Treatment Regimes Using RM 1601 Spray for Control of the 

Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project 

Number: RMD 692: P/222LT. Unpublished study prepared by 

Agresearch Consultants, Inc. 40 p. 

Decision#: (",R'O" 

810.3300fTreatments to control 

pests of humans and pets 

Sharp, M, (2009) Immediate Efficacy of a Combined Application of 81 0.3300fTreatments to control 

Frontline Plus with Cyphenothrin as a Squeeze-On Against Fleas pests of humans and pets 

(Ctenocephalides felis) and Ticks (Rhipicephalus sanguine us) on 

Dogs: Analyses of Data Conctusions, Project Number: MS/164/D. 

Unpublished study prepared by Sharp Veterinary Research. 24 p. 

McCall, J.; McTier, T. (1993) Laboratory Evaluation of RM 1601 

Spray for Control Dermacentor variabitis and Rhipecephalus 

sanguineus on the Dog: Lab Project Number: RMfTKS/93/1 L: 

PS/229LT. Unpublished study prepared by TRS Labs, Inc. 18 p. 

Gaxiola, S.; Alva, R.; IlWin, J. (2001) PR & D 0052301: Frontline 

Spray/Frontiine Spot-On/ML-2, 095, 988 

509TIDogs/SolutionfTopical: Final Report Lab Project Number: 

PR&D 0052301, PR&D 00523. Unpublished study prepared by 

University of Sinaloa. 40 p. {OPPTS 810.3300} 

Miller, T. (2009) Dose Titration with S-Methoprene Squeeze-On on 81 0,3300fTreatments to control 

Dogs Measuring Flea Egg Sterilization: Analyses of Data and pests of humans and pets 

Conclusions, Project Number: MS/172D. Unpublished study 

prepared by Sharp Veterinary Research, 42 p, 

Sharp, M. (2010) Immediate Efficacy Following Application of 

Frontline with Cyphenothrin Squeeze-On Against Fleas 

(Ctenocephalides fells) and Ticks (Rhipicephalus sanguineus) on 

Dogs: Analyses of Data Conclusions, Project Number: MS/183D. 

Unpublished study prepared by Sharp Veterinary Research. 29 p, 

Everett, R.; Cunningham, J. (1993) An Investigation Study to 

Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy 

of RM1601 Spray: Revised: Lab Project Number: RMD 592: 

P/220LT. Unpublished study prepared by Agresearch 

Consultants, Inc. 43 p. 

Marchiondo, A. (2001) PR & D 0024101: Frontline Spray/Frontline 

Spot-On/ML-2, 095, 988 509T/Dogs/Solution/Topical: Final 

Report: Lab Project Number: PR&D 0024101: PR&D 00241. 

Unpublished study prepared by Stillmeadow, Inc. 29 p. {OPPTS 

810.3300} 

McCall, J.; Alva, R.; IlWin, J.; et al. (2002) A Study to Evaluate the 

Efficacy of Frontline Plus for Control of Mosquitoes, Aedes 

aegypti, on Dogs: Final Report: Lab Project Number: PR&D 

0055201. Unpublished study prepared by TRS Labs, Inc. 24 p. 

{OPPTS 810.3300} 

810.3300fTreatments to control 

pests of humans and pets 

60

DP#: (382792) 

43121114 

45612701 

46298501 

43121115 

43121116 

48129610 

43121117 

45620505 

48189203 

48129611 

43121118 

45620504 

45866902 

Page 2 

* * * Studies Sent for Review * * * 

Frontline Top Spot, and IVlL.-<,U",',."O 

the and Control of Trichodectes canis in the Dog: 

Report: Lab Project Number: PR&D 0022101, PR&D 00221. 

Unpublished study prepared by Centro Veterinario Oriola. 24 p. 

{OPPTS 810.3300} 

Everett, R.; Cunningham, J. (1993) A Dose Titration Study to 

Determine the Optimal Spray Concentration of RM 1601 for Long 

Term Control of the Cat Flea Ctenocephalides felis and the Brown 

Dog Tick Rhipicephalus sanguineus in the Dog: Revised: Lab 

Project Number: RMD 292: P/214LT. Unpublished study prepared 

by Agresearch Consultants. 53 p. 

Ahmed, Z. (2002) Study Summaries: Frontline Plus For Dogs. 

Unpublished study prepared by Merial. 40 p. 

Miller, T. (2003) Effect of Shampoo After Treatment with 

Cyphenothrin Squeeze-on on Efficacy against Adult Cat Flease 

(Ctenocephalides felis), Adutt Brown Ticks (Rhipicephalus 

saguineus) on Dogs: Analysis of Data and Conclusions. Project 

Number: MS/20D. Unpublished study prepared by Sharp 

Veterinary Hospital and Vetoquinol N.A., Inc. 15 p, 

Cruthers, L. (1993) Product Performance: A Dose Confirmation 

Study to Verify the Optimal Spray Concentration of RM 1601 for 

Long Residual Control of the Cat Flea (Ctenocephalides felis) and 

the Brown Dog Tick (Rhipicephalus sanguine us) in the Dog: 

Revised: Lab Project Number: 9251: P/215LT. Unpublished study 

prepared by Professional Labs and Research Services, Inc. 51 

p. 

Everett, R; Cunningham, J. (1993) A Comparative Evaluation of 

Two Treatment Regimes Using RM 1601 Spray for Control of the 

Cat Flea Ctenocephalides felis on the Dog: Revised: Lab Project 

Number: RMD 692: P/222LT. Unpublished study prepared by 

Agresearch Consultants, Inc. 40 p. 

Decision#: (",R'O" 

810.3300fTreatments to control 

pests of humans and pets 

Sharp, M, (2009) Immediate Efficacy of a Combined Application of 81 0.3300fTreatments to control 

Frontline Plus with Cyphenothrin as a Squeeze-On Against Fleas pests of humans and pets 

(Ctenocephalides felis) and Ticks (Rhipicephalus sanguine us) on 

Dogs: Analyses of Data Conctusions, Project Number: MS/164/D. 

Unpublished study prepared by Sharp Veterinary Research. 24 p. 

McCall, J.; McTier, T. (1993) Laboratory Evaluation of RM 1601 

Spray for Control Dermacentor variabitis and Rhipecephalus 

sanguineus on the Dog: Lab Project Number: RMfTKS/93/1 L: 

PS/229LT. Unpublished study prepared by TRS Labs, Inc. 18 p. 

Gaxiola, S.; Alva, R.; IlWin, J. (2001) PR & D 0052301: Frontline 

Spray/Frontiine Spot-On/ML-2, 095, 988 

509TIDogs/SolutionfTopical: Final Report Lab Project Number: 

PR&D 0052301, PR&D 00523. Unpublished study prepared by 

University of Sinaloa. 40 p. {OPPTS 810.3300} 

Miller, T. (2009) Dose Titration with S-Methoprene Squeeze-On on 81 0,3300fTreatments to control 

Dogs Measuring Flea Egg Sterilization: Analyses of Data and pests of humans and pets 

Conclusions, Project Number: MS/172D. Unpublished study 

prepared by Sharp Veterinary Research, 42 p, 

Sharp, M. (2010) Immediate Efficacy Following Application of 

Frontline with Cyphenothrin Squeeze-On Against Fleas 

(Ctenocephalides fells) and Ticks (Rhipicephalus sanguineus) on 

Dogs: Analyses of Data Conclusions, Project Number: MS/183D. 

Unpublished study prepared by Sharp Veterinary Research. 29 p, 

Everett, R.; Cunningham, J. (1993) An Investigation Study to 

Evaluate the Effect of Bathing of Laboratory Dogs on the Efficacy 

of RM1601 Spray: Revised: Lab Project Number: RMD 592: 

P/220LT. Unpublished study prepared by Agresearch 

Consultants, Inc. 43 p. 

Marchiondo, A. (2001) PR & D 0024101: Frontline Spray/Frontline 

Spot-On/ML-2, 095, 988 509T/Dogs/Solution/Topical: Final 

Report: Lab Project Number: PR&D 0024101: PR&D 00241. 

Unpublished study prepared by Stillmeadow, Inc. 29 p. {OPPTS 

810.3300} 

McCall, J.; Alva, R.; IlWin, J.; et al. (2002) A Study to Evaluate the 

Efficacy of Frontline Plus for Control of Mosquitoes, Aedes 

aegypti, on Dogs: Final Report: Lab Project Number: PR&D 

0055201. Unpublished study prepared by TRS Labs, Inc. 24 p. 

{OPPTS 810.3300} 

810.3300fTreatments to control 

pests of humans and pets 
Page 3 

DP#: (382792) * * * Product and Data Package Ingredients * .. </< Decision#: (438361) 

20068-37-3 

1129121 1120068-37-3 IFipronil(9.8%) 

1105402 ~5733-16-6 IS-Methoprene(8.8%) 

1129013 ~9515-40-7 jCyphenothrin(5%) 

61
Efficacy Review 

Date: December 6, 2010 

Efficacy Reviewer: Clayton Myers, Ph.D., Encptom010gist RD-IB ,,\11 

myers.c1ayton@epa.gov \tV,V 

703-347-8874 

Risk Manager Rev.: Rosanna Louie 

Products: 

EPA Reg. #: 

A.I.'s: 

Decision #s: 

DP#s: 

Submission: 

MRIDs: 

GLP: 

MRID 48129609 

Sergeant's Fiproni1 + Cyphenothrin + Methoprene Squeeze-on for Dogs 

2517-RUE 

Fipronil (9.8%), Cyphenothrin (5.0%), S-Methoprene (8.8%) 

438361 

382792 

R31 0, New Products, RD Science Review 

Submitted: 

Cited: 

No 

48129609,48129610,48129611,48129612,48129613, 

48189203 

43121114,43121115,43121116,43121117,43121118, 

43121122,43577712,45612701,45620501,45620504, 

45620505,45620506,45628201,45866902,46298501 

Title: Overview and Summary ofFipronillCyphenothrin Dog Efficacy for Sergeant's Fiproni1 + 

Cyphenothrin Squeeze-On for Dogs (Overview of other submissions). 

Guideline: OPPTS 810.3300 

Study Summary of the Results: 

This submission is an overall summary and clarification of the other submitted MRIDs 

associated with this application 

Entomologist's ObservationslDiscussion: 

Supplementary Information 

62

Efficacy Review 

Date: December 6, 2010 

Efficacy Reviewer: Clayton Myers, Ph.D., Encptom010gist RD-IB ,,\11 

myers.c1ayton@epa.gov \tV,V 

703-347-8874 

Risk Manager Rev.: Rosanna Louie 

Products: 

EPA Reg. #: 

A.I.'s: 

Decision #s: 

DP#s: 

Submission: 

MRIDs: 

GLP: 

MRID 48129609 

Sergeant's Fiproni1 + Cyphenothrin + Methoprene Squeeze-on for Dogs 

2517-RUE 

Fipronil (9.8%), Cyphenothrin (5.0%), S-Methoprene (8.8%) 

438361 

382792 

R31 0, New Products, RD Science Review 

Submitted: 

Cited: 

No 

48129609,48129610,48129611,48129612,48129613, 

48189203 

43121114,43121115,43121116,43121117,43121118, 

43121122,43577712,45612701,45620501,45620504, 

45620505,45620506,45628201,45866902,46298501 

Title: Overview and Summary ofFipronillCyphenothrin Dog Efficacy for Sergeant's Fiproni1 + 

Cyphenothrin Squeeze-On for Dogs (Overview of other submissions). 

Guideline: OPPTS 810.3300 

Study Summary of the Results: 

This submission is an overall summary and clarification of the other submitted MRIDs 

associated with this application 

Entomologist's ObservationslDiscussion: 

Supplementary Information 
MRID 48129810 

Title: Immediate Efficacy of a Combined Application of Frontline Plus with Cyphenothrin as a 

Squeeze-on against Fleas (Ctenocephalis felis) and Ticks (Rhipicephalus sanguine us) on Dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Frontline plus at 3 rates (5%, 10%, and 

15%) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but 

dilution was not taken into account for the existing fipronil, therefore fipronil dosage was 

slightly lower than that of Frontline alone. 18 dogs were allocated to 6 groups 00 dogs each. 

Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at 

described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and 

again at 7 and 14 days after treatment. Counts were made at 1 and 4 hours post treatment and 

also on day 14 at 1 and 4 hours post placement-this was to measure speed ofkiIl and/or 

repellency. Counts were also made at 24 and 48 hours after initial infestation and all reinfestations. Parasites were not removed until the final count. Mortality was calculated using 

Abbott's formula. For speed ofkiU/repellence, the number ofkiIled/repelled fleas on the liner 

below each treated dog was divided by the total number of fleas placed on the dog (all x 100), 

adjusted for 'normal' attrition on control dogs. 

Study Summary of the Results: 

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 14 days after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) ranged 

from 9-74% for 1-4 hours immediately after treatment. With reinfestations after 14 

days from treatment, efficacy exceeded 99% within 4 hours for all treatments that 

included cyphenothrin. 

3. Immediate efficacy on ticks ranged from 2-64% for 1-2 hours immediately after 

treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95% 

within 1 hour, for the lowest percentage of cyphenothrin treatment, and exceeded 

84% for all treatments. 

Entomologist's Observationsmicussion: 

1. Efficacy against fleas and ticks was adequate to support controls claims through 14 

days after treatment. 

2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1 

and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 

90% with any consistency for the treatments evaluated immediately after treatment. 

However, after 14 days, this immediate efficacy was observed for reinfestations of 

both fleas and ticks. This is likely due to the more complete spread of the spot-on 

material throughout the animal coat at 14 days. Claims for killing (or 'starts killing') 

within hours would be supported by this data, but not immediately after treatment of 

the animals. 

63

MRID 48129810 

Title: Immediate Efficacy of a Combined Application of Frontline Plus with Cyphenothrin as a 

Squeeze-on against Fleas (Ctenocephalis felis) and Ticks (Rhipicephalus sanguine us) on Dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Frontline plus at 3 rates (5%, 10%, and 

15%) for efficacy evaluations. Dose volumes applied were based on the Frontline label, but 

dilution was not taken into account for the existing fipronil, therefore fipronil dosage was 

slightly lower than that of Frontline alone. 18 dogs were allocated to 6 groups 00 dogs each. 

Group 1, untreated control; Group 2, Frontline alone, Groups 3-5 Frontline plus cyphenothrin at 

described rates. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and 

again at 7 and 14 days after treatment. Counts were made at 1 and 4 hours post treatment and 

also on day 14 at 1 and 4 hours post placement-this was to measure speed ofkiIl and/or 

repellency. Counts were also made at 24 and 48 hours after initial infestation and all reinfestations. Parasites were not removed until the final count. Mortality was calculated using 

Abbott's formula. For speed ofkiU/repellence, the number ofkiIled/repelled fleas on the liner 

below each treated dog was divided by the total number of fleas placed on the dog (all x 100), 

adjusted for 'normal' attrition on control dogs. 

Study Summary of the Results: 

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 14 days after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) ranged 

from 9-74% for 1-4 hours immediately after treatment. With reinfestations after 14 

days from treatment, efficacy exceeded 99% within 4 hours for all treatments that 

included cyphenothrin. 

3. Immediate efficacy on ticks ranged from 2-64% for 1-2 hours immediately after 

treatment. With reinfestations after 14 days from treatment, efficacy exceeded 95% 

within 1 hour, for the lowest percentage of cyphenothrin treatment, and exceeded 

84% for all treatments. 

Entomologist's Observationsmicussion: 

1. Efficacy against fleas and ticks was adequate to support controls claims through 14 

days after treatment. 

2. While immediate efficacy against fleas and ticks was enhanced when assessed at 1 

and 4 hours after treatment (or reinfestation), the immediate efficacy did not exceed 

90% with any consistency for the treatments evaluated immediately after treatment. 

However, after 14 days, this immediate efficacy was observed for reinfestations of 

both fleas and ticks. This is likely due to the more complete spread of the spot-on 

material throughout the animal coat at 14 days. Claims for killing (or 'starts killing') 

within hours would be supported by this data, but not immediately after treatment of 

the animals. 
MRID 48129811 

Title: Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze-on 

against Fleas (Ctenocephalis felis) and Ticks (Rhipicephalus sanguineus) on Dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately 

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the 

Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil 

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of 6 

dogs each. Group I, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline 

alone .. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 

14,21, and 28 days after treatment. Counts were made at 1 and 4 hours post treatment and also 

after every reinfestation-this was to measure speed of kill and/or repellency. Counts were also 

made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not 

removed until the final count. Mortality was calculated using Abbott's formula. For speed of 

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was 

divided by the total number of fleas placed on the dog (all x 100), adjusted for 'normal' attrition 

on control dogs. 

Stndy Snmmary of the Results: 

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 28 days after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) ranged 

from 9-68% for 1-4 hours immediately after treatment. With reinfestations after 7, 

14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all 

treatments that included cyphenothrin, but did not exceed 90% within I hour after 

reinfestation. 

3. Immediate efficacy on ticks ranged from 5-75% for 1-2 hours immediately after 

treatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy 

exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment, 

adequate efficacy was observed within I hour of reinfestation. 

Entomologist's ObservationslDicnssion: 

I. Efficacy against fleas and ticks was adequate to support controls claims through 28 

days (one month) after treatment. 

2. While immediate efficacy against fleas and ticks was marginally enhanced when 

assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did 

not exceed 90% with any consistency for the treatments evaluated immediately after 

treatment. However, after 7 days, this immediate efficacy was observed for 

reinfestations of both fleas and ticks. This is likely due to the more complete spread 

of the spot-on material throughout the animal coat at 7+ days. Claims for killing (or 

64

MRID 48129811 

Title: Immediate Efficacy Following Application of Frontline with Cyphenothrin Squeeze-on 

against Fleas (Ctenocephalis felis) and Ticks (Rhipicephalus sanguineus) on Dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately 

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the 

Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil 

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of 6 

dogs each. Group I, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline 

alone .. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 

14,21, and 28 days after treatment. Counts were made at 1 and 4 hours post treatment and also 

after every reinfestation-this was to measure speed of kill and/or repellency. Counts were also 

made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not 

removed until the final count. Mortality was calculated using Abbott's formula. For speed of 

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was 

divided by the total number of fleas placed on the dog (all x 100), adjusted for 'normal' attrition 

on control dogs. 

Stndy Snmmary of the Results: 

1. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 28 days after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) ranged 

from 9-68% for 1-4 hours immediately after treatment. With reinfestations after 7, 

14,21, and 28 days from treatment, efficacy exceeded 90% within 4 hours for all 

treatments that included cyphenothrin, but did not exceed 90% within I hour after 

reinfestation. 

3. Immediate efficacy on ticks ranged from 5-75% for 1-2 hours immediately after 

treatment. With reinfestations after 7, 14,21, and 28 days from treatment, efficacy 

exceeded 90% within 4 hours for all dates. For 21 and 28 days from treatment, 

adequate efficacy was observed within I hour of reinfestation. 

Entomologist's ObservationslDicnssion: 

I. Efficacy against fleas and ticks was adequate to support controls claims through 28 

days (one month) after treatment. 

2. While immediate efficacy against fleas and ticks was marginally enhanced when 

assessed at 1 and 4 hours after treatment (or reinfestation), the immediate efficacy did 

not exceed 90% with any consistency for the treatments evaluated immediately after 

treatment. However, after 7 days, this immediate efficacy was observed for 

reinfestations of both fleas and ticks. This is likely due to the more complete spread 

of the spot-on material throughout the animal coat at 7+ days. Claims for killing (or 
'starts killing') within hours would be supported by this data, but not immediately 

after treatment of the animals. 

MRID 48129812 

Title: Immediate Efficacy Following Application of Frontline Plus with Cyphenothrin Squeezeon against Fleas (Ctenocephalisfelis) and Ticks (Rhipicephalus sanguine us) on Dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately 

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the 

Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil 

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of 6 

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline 

alone .. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 

14,21,28, and 35 days after treatment. Counts were made at 1 and 4 hours post treatment and 

also after every reinfestation-this was to measure speed of kill and/or repellency. Counts were 

also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not 

removed until the final count. Mortality was calculated using Abbott's formula. For speed of 

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was 

divided by the total number of fleas placed on the dog (all x 100), adjusted for 'normal' attrition 

on control dogs. 

Study Summary of the Results: 

I. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 35 days after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) ranged 

from 0-75% for 1-4 hours immediately after treatment. With reinfestations after 7, 

14,21,28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all 

only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for 

reinfestations on days 14,21,28, or 35 days after treatment. 

3. Immediate efficacy on ticks ranged from 11-71 % for 1-4 hours immediately after 

treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy 

exceeded 90% within 4 hours for only the 7 day reinfestation. Efficacy did not 

exceed 90% within 4 hours for reinfestations on days 14, 21, 28, or 35 days after 

treatment. 

Entomologist's ObservationsIDicussion: 

I. Efficacy against fleas and ticks was adequate to support controls claims through 35 

days (one month) after treatment. 

2. While immediate efficacy against fleas and ticks was marginally enhanced when 

assessed at I and 4 hours after treatment (or reinfestation) compared to fipronil alone, 

65

'starts killing') within hours would be supported by this data, but not immediately 

after treatment of the animals. 

MRID 48129812 

Title: Immediate Efficacy Following Application of Frontline Plus with Cyphenothrin Squeezeon against Fleas (Ctenocephalisfelis) and Ticks (Rhipicephalus sanguine us) on Dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Frontline plus at the rate of approximately 

5% (4.76% cyphenothrin) for efficacy evaluations. Dose volumes applied were based on the 

Frontline label, but dilution was not taken into account for the existing fipronil, therefore fipronil 

dosage was slightly lower than that of Frontline alone. 18 dogs were allocated to 3 groups of 6 

dogs each. Group 1, untreated control; Group 2, Frontline+cyphenothrin, Groups 3, Frontline 

alone .. Dogs were infested with 100 fleas and 50 ticks one day before treatment, and again at 7, 

14,21,28, and 35 days after treatment. Counts were made at 1 and 4 hours post treatment and 

also after every reinfestation-this was to measure speed of kill and/or repellency. Counts were 

also made at 24 and 48 hours after initial infestation and all re-infestations. Parasites were not 

removed until the final count. Mortality was calculated using Abbott's formula. For speed of 

kill/repellence, the number of killed/repelled fleas on the liner below each treated dog was 

divided by the total number of fleas placed on the dog (all x 100), adjusted for 'normal' attrition 

on control dogs. 

Study Summary of the Results: 

I. Mean efficacy against fleas and ticks exceeded 90% when assessed at 1-2 days after 

treatment or reinfestation with parasites, through 35 days after treatment. 

2. Immediate efficacy on fleas (i.e. kill/repellence within 4 hours of treatment) ranged 

from 0-75% for 1-4 hours immediately after treatment. With reinfestations after 7, 

14,21,28, and 35 days from treatment, efficacy exceeded 90% within 4 hours for all 

only the 7 day reinfestation. Efficacy did not exceed 90% within 4 hours for 

reinfestations on days 14,21,28, or 35 days after treatment. 

3. Immediate efficacy on ticks ranged from 11-71 % for 1-4 hours immediately after 

treatment. With reinfestations after 7,14,21, and 28 days from treatment, efficacy 

exceeded 90% within 4 hours for only the 7 day reinfestation. Efficacy did not 

exceed 90% within 4 hours for reinfestations on days 14, 21, 28, or 35 days after 

treatment. 

Entomologist's ObservationsIDicussion: 

I. Efficacy against fleas and ticks was adequate to support controls claims through 35 

days (one month) after treatment. 

2. While immediate efficacy against fleas and ticks was marginally enhanced when 

assessed at I and 4 hours after treatment (or reinfestation) compared to fipronil alone, 
the immediate efficacy did not exceed 90% with any consistency for the treatments 

evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days 

after treatment. This data does not support any claims for faster kill or repellence due 

to the addition of cyphenothrin. 

MRID 48129813 

Title: Comparative efficacy evaluation of Sergeant's Squeeze-on and Frontline Plus for the 

treatment of adult cat flea (Ctenocephalides felis) and tick (Haemaphysalis elliptica, 

Rhipicephalus sanguine us, and Dermacentor variabilis) infestations on dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil-Methroprene 

formulation Frontline plus at the rate of approximately 5% for efficacy evaluations. This 

treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline 

Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mLlkg body 

weight, to simulate the dosing at the high end of each respective weight class. Dogs were 

subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs of each class 

in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3, 

Fipronil+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs were infested with 100 fleas 

and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days after treatment. 

Counts were made at 1 and 4 hours post treatment and also after every reinfestation-this was to 

measure speed of kill and/or repellency. Counts were also made at 24 and 48 hours after initial 

infestation and all re-infestations. Parasites were not removed until the final count. Mortality 

was calculated using Abbott's formula. For speed ofkill/repellence, the number of 

killed/repelled fleas on the liner below each treated dog was divided by the total number of fleas 

placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. 

Study Summary ofthe Results: 

1. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment or 

reinfestation with parasites, through 28 days after treatment. 

2. Immediate group mean efficacy on ticks (all species) overall means were all below 

90%. 

Entomologist's ObservationslDicussion: 

1. Efficacy against fleas and ticks was adequate to support controls general claims 

through 35 days (one month) after treatment. 

2. No immediate efficacy claims (i.e., within 1-4 hours of application or reinfestation by 

parasites) are supported by this data. 

66

the immediate efficacy did not exceed 90% with any consistency for the treatments 

evaluated immediately 1-4 hours after initial treatment or reinfestation beyond 7 days 

after treatment. This data does not support any claims for faster kill or repellence due 

to the addition of cyphenothrin. 

MRID 48129813 

Title: Comparative efficacy evaluation of Sergeant's Squeeze-on and Frontline Plus for the 

treatment of adult cat flea (Ctenocephalides felis) and tick (Haemaphysalis elliptica, 

Rhipicephalus sanguine us, and Dermacentor variabilis) infestations on dogs. 

Guideline: OPPTS 810.3300 

Materials and Methods: Cyphenothrin was added to Seargeant's Fipronil-Methroprene 

formulation Frontline plus at the rate of approximately 5% for efficacy evaluations. This 

treatment was compared to fipronil-methoprene alone, and a positive control, Merial's Frontline 

Plus. Dose volumes applied were based on a titration by which dogs received 0.067 mLlkg body 

weight, to simulate the dosing at the high end of each respective weight class. Dogs were 

subgrouped by weight class with 6 dogs in each subclass (split over time to 3 dogs of each class 

in 2 consecutive studies). Group 1, untreated control; Group 2, Fipronil+Methoprene, Group 3, 

Fipronil+Methoprene+cyphenothrin, Group 4, Frontline Plus. Dogs were infested with 100 fleas 

and 50 ticks one day before treatment, and again at 7, 14,21, and 28 days after treatment. 

Counts were made at 1 and 4 hours post treatment and also after every reinfestation-this was to 

measure speed of kill and/or repellency. Counts were also made at 24 and 48 hours after initial 

infestation and all re-infestations. Parasites were not removed until the final count. Mortality 

was calculated using Abbott's formula. For speed ofkill/repellence, the number of 

killed/repelled fleas on the liner below each treated dog was divided by the total number of fleas 

placed on the dog (all x 100), adjusted for 'normal' attrition on control dogs. 

Study Summary ofthe Results: 

1. Mean efficacy against fleas exceeded 90% when assessed at 2 days after treatment or 

reinfestation with parasites, through 28 days after treatment. 

2. Immediate group mean efficacy on ticks (all species) overall means were all below 

90%. 

Entomologist's ObservationslDicussion: 

1. Efficacy against fleas and ticks was adequate to support controls general claims 

through 35 days (one month) after treatment. 

2. No immediate efficacy claims (i.e., within 1-4 hours of application or reinfestation by 

parasites) are supported by this data. 
MRID 48189203 

Title: Dose Titration with S-Methoprene Squeeze-Ons with Dogs Measuring Flea Egg 

Sterilization 

Guideline: OPPTS 810.3300 

Materials and Methods: 18 dogs were allocated to this study, with 6 in an untreated control 

group, and 2 each into 6 groups that received s-methoprene spot-on treatments at various dose 

rates based on weights of the 2 dogs, and designed to provide a range of dose rates from 3 mg/kg 

to 48 mg/kg. Dogs were infested with fleas 24 hours after treatment, and again weekly 

thereafter. Flea eggs were collected overnights from pans below each dog 1-2 times during the 

week after each re-infestation. Flea eggs were sorted into 2 aliquots of approximately 25 eachone incubated to measure fertility of the eggs, and the other incubated in a flea-growing medium 

to determine the number of fleas that developed from the eggs after 35 days. % hatch was 

calculated. % hatch reduction efficacy was calculated using Abbott's formula. Less than 90% 

on 2 or more successive collections was a criteria for treatment failure. Data was analyzed for 

correlation between dose and the duration of efficacy, to enable prediction of the duration of 

adequate efficacy at various doses. 

Study Summary of the Results: 

1. Application of the regression equation predicts residual efficacy in sterilizing female 

fleas and killing their eggs at a duration of 57 days for the largest heaviest dogs in the 

treatment regime to 122 days for the smallest dogs. 

2. The adult emergence efficacy was terminated at 108 days with 100% efficacy for the five 

highest rates and >63 days for the lowest 

Entomologist's ObservationslDiscussion 

I. For the largest dogs (i.e., the lowest dosage of a.i. per kg dog weight), egg sterilization 

lasted 57 days and inhibition of adult emergence lasted 63 days. Therefore claims against 

flea eggs, larvae, and breaking of the flea life cycle is supported for 2 months (8 weeks). 

Claims must be revised to reflect this supported duration. 

Overall Review of Label Claims and Directions: 

Based upon submitted efficacy data, claims are supported for fleas and ticks through 35 days. 

Claims for immediate efficacy are not supported except to state "starts killing within hours" or 

"starts killing in as little as one hour". RepeUence claims for fleas and ticks are not supported 

and must be removed from the label. Kill claims against flea eggs or larvae, are supported. 

Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are 

supported for up to 2 months after treatment, however claims of 'up to 4 months' are acceptable, 

as this efficacy was supported for some dogs. 

67

MRID 48189203 

Title: Dose Titration with S-Methoprene Squeeze-Ons with Dogs Measuring Flea Egg 

Sterilization 

Guideline: OPPTS 810.3300 

Materials and Methods: 18 dogs were allocated to this study, with 6 in an untreated control 

group, and 2 each into 6 groups that received s-methoprene spot-on treatments at various dose 

rates based on weights of the 2 dogs, and designed to provide a range of dose rates from 3 mg/kg 

to 48 mg/kg. Dogs were infested with fleas 24 hours after treatment, and again weekly 

thereafter. Flea eggs were collected overnights from pans below each dog 1-2 times during the 

week after each re-infestation. Flea eggs were sorted into 2 aliquots of approximately 25 eachone incubated to measure fertility of the eggs, and the other incubated in a flea-growing medium 

to determine the number of fleas that developed from the eggs after 35 days. % hatch was 

calculated. % hatch reduction efficacy was calculated using Abbott's formula. Less than 90% 

on 2 or more successive collections was a criteria for treatment failure. Data was analyzed for 

correlation between dose and the duration of efficacy, to enable prediction of the duration of 

adequate efficacy at various doses. 

Study Summary of the Results: 

1. Application of the regression equation predicts residual efficacy in sterilizing female 

fleas and killing their eggs at a duration of 57 days for the largest heaviest dogs in the 

treatment regime to 122 days for the smallest dogs. 

2. The adult emergence efficacy was terminated at 108 days with 100% efficacy for the five 

highest rates and >63 days for the lowest 

Entomologist's ObservationslDiscussion 

I. For the largest dogs (i.e., the lowest dosage of a.i. per kg dog weight), egg sterilization 

lasted 57 days and inhibition of adult emergence lasted 63 days. Therefore claims against 

flea eggs, larvae, and breaking of the flea life cycle is supported for 2 months (8 weeks). 

Claims must be revised to reflect this supported duration. 

Overall Review of Label Claims and Directions: 

Based upon submitted efficacy data, claims are supported for fleas and ticks through 35 days. 

Claims for immediate efficacy are not supported except to state "starts killing within hours" or 

"starts killing in as little as one hour". RepeUence claims for fleas and ticks are not supported 

and must be removed from the label. Kill claims against flea eggs or larvae, are supported. 

Control claims against flea eggs or larvae, or claims against breaking the flea life cycle are 

supported for up to 2 months after treatment, however claims of 'up to 4 months' are acceptable, 

as this efficacy was supported for some dogs. 
Line by Line Review of Label Efficacy Claims 

Kills fleas (in as little as I hour), flea eggs, ticks (in as little as one hour), chewing lice & 

mosquitoes: Unacceptable unless revised to 'starts killing' for fleas and ticks. 

Kills (and Repels) Fleas, Ticks, and Mosquitoes: Repels claim must be deleted. 

Controls flea reinfestation for up to [16 weeksl: Acceptable 

Fast Acting: Unacceptable 

Kills ticks (in as little as I hour): Acceptable only if revised to say 'starts killing' 

Kills ticks including those that may transmit Lyme disease: Acceptable 

Dogs can be bathed 24 hours after treatment: Unacceptable 

Waterproof: Acceptable 

Long Lasting: Acceptable 

Research demonstrates that [brand namel kills adult fleas (in as little as I hour), flea eggs, larvae 

and pupae for up to four months: Acceptable only if revised to 'starts' killing. Claim against 

'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed 

to residue. 

[brand namel prevents development of all flea stages for up to four months: Acceptable 

Kills fleas (in as little as I hour), ticks (in as little as 1 hour), mosquitoes, (chewing) lice, flea 

eggs, larvae, and pupae: Acceptable only if kills claims are revised to 'starts killing' 

j U- "Prevents all flea stages (adult fleas (in as little as 1 hour), flea eggs, flea pupae, and flea larvae}: 

J Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the 

product kills flea pupae exposed to residue. 

If dog is a high risk for flea re-infestation once a month application may be needed: Acceptable. 

Once a month treatment is recommended: Acceptable. 

A once monthly application is recommended for chewing lice: Acceptable. 

Rapidly eliminates infestations with chewing lice: Acceptable; 

Monthly flea, tick, mosquito, lice, and flea egg protection: Acceptable. 

Monthly flea, tick, mosquito, and lice protection: Acceptable. 

68

Line by Line Review of Label Efficacy Claims 

Kills fleas (in as little as I hour), flea eggs, ticks (in as little as one hour), chewing lice & 

mosquitoes: Unacceptable unless revised to 'starts killing' for fleas and ticks. 

Kills (and Repels) Fleas, Ticks, and Mosquitoes: Repels claim must be deleted. 

Controls flea reinfestation for up to [16 weeksl: Acceptable 

Fast Acting: Unacceptable 

Kills ticks (in as little as I hour): Acceptable only if revised to say 'starts killing' 

Kills ticks including those that may transmit Lyme disease: Acceptable 

Dogs can be bathed 24 hours after treatment: Unacceptable 

Waterproof: Acceptable 

Long Lasting: Acceptable 

Research demonstrates that [brand namel kills adult fleas (in as little as I hour), flea eggs, larvae 

and pupae for up to four months: Acceptable only if revised to 'starts' killing. Claim against 

'pupae' must be deleted, as no data was submitted indicating the product kills flea pupae exposed 

to residue. 

[brand namel prevents development of all flea stages for up to four months: Acceptable 

Kills fleas (in as little as I hour), ticks (in as little as 1 hour), mosquitoes, (chewing) lice, flea 

eggs, larvae, and pupae: Acceptable only if kills claims are revised to 'starts killing' 

j U- "Prevents all flea stages (adult fleas (in as little as 1 hour), flea eggs, flea pupae, and flea larvae}: 

J Acceptable except claim against 'pupae' must be deleted, as no data was submitted indicating the 

product kills flea pupae exposed to residue. 

If dog is a high risk for flea re-infestation once a month application may be needed: Acceptable. 

Once a month treatment is recommended: Acceptable. 

A once monthly application is recommended for chewing lice: Acceptable. 

Rapidly eliminates infestations with chewing lice: Acceptable; 

Monthly flea, tick, mosquito, lice, and flea egg protection: Acceptable. 

Monthly flea, tick, mosquito, and lice protection: Acceptable. 
Kills flea eggs [larvae] [pupae] for up to 4 months: Acceptable except claim against 'pupae' 

must be deleted, as no data was submitted indicating the product kills flea pupae exposed to 

residue. 

Aids in control of sarcoptic mange: Acceptable. 

Kills fleas (in as little as I hour), ticks (in as little as 1 hour), mosquitoes, flea eggs, and lice: 

Acceptable only ifkills claims are revised to 'starts killing'. 

[Seven] [7] Way Protection! Kills fleas (in as little as 1 hour), ticks (in as little as I hour), 

mosquitoes, lice flea eggs, & flea larvae: '7-way' is an unacceptable nebulous claim. Kills 

claims must be revised to 'starts killing' 

6 [Six] Way Protection! Kills fleas (in as little as I hour), ticks (in as little as 1 hour), 

mosquitoes, lice, flea eggs & flea larvae: '6-way' is an unacceptable nebulous claim. Kills 

claims must be revised to 'starts killing' 

[4 Week] [Flea and Tick & Treatment]: Acceptable 

Four (4) Week Flea, Tick, Mosquitoe and Lice Control: Acceptable 

With (s)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable 

With (s)-methoprene to Break Flea Life Cycle: Acceptable 

With Insect Growth Regulator to Break Flea Life Cycle: Acceptable 

Triple Action [I]: Fipronil and Cyphenothrin with (s)-methoprene IGR Effectively Breaks the 

Flea Life Cycle: Acceptable 

Triple Action [!]: Effectively Breaks the Flea Life Cycle [I]: Acceptable 

Best if used year round!: Acceptable 

Kills & Repels Fleas (in as little as I hour) Up to [4 weeks]!: Kills must be revised to 'starts 

killing' and 'repels' claim must be deleted. 

(ICON showing 4 week protection): Acceptable 

4 Week Dose!: Acceptable 

1 Month Dose!: Acceptable 

Specially Formulated for Dogs and Puppies: Acceptable 

69

Kills flea eggs [larvae] [pupae] for up to 4 months: Acceptable except claim against 'pupae' 

must be deleted, as no data was submitted indicating the product kills flea pupae exposed to 

residue. 

Aids in control of sarcoptic mange: Acceptable. 

Kills fleas (in as little as I hour), ticks (in as little as 1 hour), mosquitoes, flea eggs, and lice: 

Acceptable only ifkills claims are revised to 'starts killing'. 

[Seven] [7] Way Protection! Kills fleas (in as little as 1 hour), ticks (in as little as I hour), 

mosquitoes, lice flea eggs, & flea larvae: '7-way' is an unacceptable nebulous claim. Kills 

claims must be revised to 'starts killing' 

6 [Six] Way Protection! Kills fleas (in as little as I hour), ticks (in as little as 1 hour), 

mosquitoes, lice, flea eggs & flea larvae: '6-way' is an unacceptable nebulous claim. Kills 

claims must be revised to 'starts killing' 

[4 Week] [Flea and Tick & Treatment]: Acceptable 

Four (4) Week Flea, Tick, Mosquitoe and Lice Control: Acceptable 

With (s)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle: Acceptable 

With (s)-methoprene to Break Flea Life Cycle: Acceptable 

With Insect Growth Regulator to Break Flea Life Cycle: Acceptable 

Triple Action [I]: Fipronil and Cyphenothrin with (s)-methoprene IGR Effectively Breaks the 

Flea Life Cycle: Acceptable 

Triple Action [!]: Effectively Breaks the Flea Life Cycle [I]: Acceptable 

Best if used year round!: Acceptable 

Kills & Repels Fleas (in as little as I hour) Up to [4 weeks]!: Kills must be revised to 'starts 

killing' and 'repels' claim must be deleted. 

(ICON showing 4 week protection): Acceptable 

4 Week Dose!: Acceptable 

1 Month Dose!: Acceptable 

Specially Formulated for Dogs and Puppies: Acceptable 
Kills Flea Eggs & Flea Larvae for [(4 months)]!: Unacceptable unless revised to '2 months' or 

'up to 4 months'. 

Prevents Flea Eggs From Developing Into Biting Adults: Acceptable 

Kills Ticks (in as little as I hour) for Up to [4 weeks]!: Acceptable only if revised to 'starts 

killing' . 

Kills [all stages of! Deer Ticks (vector of Lyme Disease) for up to 4 weeks: Acceptable 

Kills Ticks (in as little as I hour): Acceptable only if revised to 'starts killing' 

Kills Ticks including Deer Ticks for up to 4 weeks: Acceptable 

Kills Brown Dog Ticks (in as little as I hour): Acceptable only if revised to 'starts killing' 

Kills [Brown], [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable 

Kills Rhipicephalus sanguine us for up to 4 weeks: Acceptable 

When used monthly [brand name] completely breaks the flea life cycle and controls tick and 

chewing lice infestations: Acceptable 

Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!: Acceptable 

Apply once every [4 weeks]!: Acceptable 

4 weeks Flea and Tick Treatment: Acceptable 

Once A Month Flea and Tick Treatment: Acceptable 

Kills & Repels Fleas (in as little as I hour) and Ticks (in as little as I hour) for up to 4 weeks!: 

Only acceptable if revised to starts killing, and also the repels claim must be deleted. 

Kills all stages of the flea life cycle: Acceptable 

Kills fleas (in as little as I hour). Ticks (in as little as I hour), Flea Eggs & Flea Larvae for up to 

16 Weeks: Acceptable only if revised to 'starts killing' 

Kills mosquitoes: Acceptable 

Dogs can be bathed 24 hours after squeeze-on is applied: Unacceptable 

Prevents and controls reinfestations: Unacceptable unless a pest and duration of control is 

associated (e.g., 'prevents and controls reinfestations oflisted pests for I month [4 weeks n. 

70

Kills Flea Eggs & Flea Larvae for [(4 months)]!: Unacceptable unless revised to '2 months' or 

'up to 4 months'. 

Prevents Flea Eggs From Developing Into Biting Adults: Acceptable 

Kills Ticks (in as little as I hour) for Up to [4 weeks]!: Acceptable only if revised to 'starts 

killing' . 

Kills [all stages of! Deer Ticks (vector of Lyme Disease) for up to 4 weeks: Acceptable 

Kills Ticks (in as little as I hour): Acceptable only if revised to 'starts killing' 

Kills Ticks including Deer Ticks for up to 4 weeks: Acceptable 

Kills Brown Dog Ticks (in as little as I hour): Acceptable only if revised to 'starts killing' 

Kills [Brown], [American.] [and Lone Stare] Dog Ticks for up to 4 weeks: Acceptable 

Kills Rhipicephalus sanguine us for up to 4 weeks: Acceptable 

When used monthly [brand name] completely breaks the flea life cycle and controls tick and 

chewing lice infestations: Acceptable 

Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!: Acceptable 

Apply once every [4 weeks]!: Acceptable 

4 weeks Flea and Tick Treatment: Acceptable 

Once A Month Flea and Tick Treatment: Acceptable 

Kills & Repels Fleas (in as little as I hour) and Ticks (in as little as I hour) for up to 4 weeks!: 

Only acceptable if revised to starts killing, and also the repels claim must be deleted. 

Kills all stages of the flea life cycle: Acceptable 

Kills fleas (in as little as I hour). Ticks (in as little as I hour), Flea Eggs & Flea Larvae for up to 

16 Weeks: Acceptable only if revised to 'starts killing' 

Kills mosquitoes: Acceptable 

Dogs can be bathed 24 hours after squeeze-on is applied: Unacceptable 

Prevents and controls reinfestations: Unacceptable unless a pest and duration of control is 

associated (e.g., 'prevents and controls reinfestations oflisted pests for I month [4 weeks n. 
BACK/SIDE CARTON LABEL-MASTER LABEL 

[brand name] containes Fiproni!, cyphenothrin, and the insect growth regulator (IGR) (s)-

methoprene to effectively kill [and repelJ Fleas [(in as little as 1 hour)), Ticks [(in as little as I 

hour)], and kills mosquitoes and (chewing) lice. The active ingredients in [brand name] work by 

collecting in the hair follicles and skin oils. This product features a sustained-release formula 

that discharges from the animal's hair follicles using the natural skin oils, resulting in fast acting 

[and long lasting] control of Fleas and Ticks [(in as little as one hour)), [and kills mosquitoes] 

and chewing lice [for 30 days: All repels claims must be removed from the label. All references 

to action in as little as 1 hour must be revised to 'starts acting' or 'starts killing' or alternatively, 

the claims of 'in little as I hour' can be removed. 'Fast acting' claim must be removed. The 

claims about movement in hair follicles is deferred to the RM Reviewer and PM. 

71

BACK/SIDE CARTON LABEL-MASTER LABEL 

[brand name] containes Fiproni!, cyphenothrin, and the insect growth regulator (IGR) (s)-

methoprene to effectively kill [and repelJ Fleas [(in as little as 1 hour)), Ticks [(in as little as I 

hour)], and kills mosquitoes and (chewing) lice. The active ingredients in [brand name] work by 

collecting in the hair follicles and skin oils. This product features a sustained-release formula 

that discharges from the animal's hair follicles using the natural skin oils, resulting in fast acting 

[and long lasting] control of Fleas and Ticks [(in as little as one hour)), [and kills mosquitoes] 

and chewing lice [for 30 days: All repels claims must be removed from the label. All references 

to action in as little as 1 hour must be revised to 'starts acting' or 'starts killing' or alternatively, 

the claims of 'in little as I hour' can be removed. 'Fast acting' claim must be removed. The 

claims about movement in hair follicles is deferred to the RM Reviewer and PM. 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

October 4,2010 

OPP Decision Number: D-438361 

EPA File Symbol or Registration Number: 2517-RUE 

OFFICE OF 

PREVENTION. PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FOR DOGS 

EPA Receipt Date: ll-Aug-2010 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has determined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action previously identified as R320 has been reclassified as Action Code: R31 0 

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY); 

The fee associated with this aciton is $ 2,289 (50% of$ 4,578). Payment if the amount of 

$ 5,712 has been received. A refund in the amount of$ 3,423 will be issued as soon as the action 

is completed. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerel , 

Fro Procecc~'''''''''',ff' 

fo gy & Resources Management Division 

72
Memorandum 

Date: U j 9 / I 0 

To: p IkJ 10 , Regulatory Manager 

From: Information Services Branch, ITRMD 

Your receipt of this data submission is not an 

indication that MRIDs for the enclosed studies have 

been posted to OPPIN. 

We expect that it will be approximately 5 days 

from the above date before the study-level data is 

available in OPPIN. 

If you have any questions about this process, 

please contact Teresa Downs (305-5363). 

This is a: S--fully accepted submission 

D partially accepted submission 

D rejected submission 

73

Memorandum 

Date: f / j 9 / I 0 

To: ___ -'-P--'-/..::.J.·l1_.L.-'1 0",,-· ___ ,Regulatory Manager 

From: Information Services Branch, ITRMD 

Your receipt of this data submission is not an 

indication that MRIDs for the enclosed studies have 

been posted to OPPIN. 

We expect that it will be approximately 5 days 

from the above date before the study-level data is 

available in OPPIN. 

If you have any questions about this process, 

please contact Teresa Downs (305-5363). 

This is a: S--fully accepted submission 

D partially accepted submission 

D rejected submission 
Completion of 21-Day Content Screen 

PM- /0 

EPA Reg. #(File Symbol) as 11- kL1~ 

Decision # D 

Thank you, 

------

Data package delivered to 

you on 0/19/ j() • 

(date) 

Jacket/Mini-jacket will be 

transferred to you today. 

(Pick up from Document Center) 

Registration Division's 21-Day Content Team 

74
To the Document Center (ITRMD) 

*Please transfer jacket/mini-jacket to the Product Manager 

Team circled below: 

Minor Use Section: PM-5 

Insecticide Branch: PM-lO PM-l3 

Herbicide Branch: PM-23 PM-25 

Fungicide Branch: PM-20 PM-2l PM-22 

InsectIRodent Branch: PM-l PM-7 

*Reminder to PM - If applicable, pick-up data from the 

Screening Room. 

Processed by RD's Completeness Check Team 

(Team Member Signature) (Date) 

75
21-Day Screen Completed by 

Contractor 

21-Day Expires on ~9~-/~-~/O~~_ 

Jacket # ;?!3 /7-f(r.)G 

MRID# t/ej / g 9 :JContent Screen: Recommended to 

IPasSYFaH 

86=5 ReView:JPasse~/Faned/NA 

Transfer This Jacket to: 

;OJI;I-IO 

76
PRIA 2 - 21 Day Content Screen Review Worksheet 

(EPA/OPP Use Only) 

3/23/09 

21 Day Screen Start Date: /( - If - 10 

Experts In-Processing Signature: yv}1:: t-lA-tn./ICToN Date 8--/2 -/0 Fee Paid: Yes ~ Division management contacted on issues No Yes Date ______ _ 

EPA Reg. Number: "LStl - R.uE. EPA Receipt Date: 2(- 1/- 10 

Items for Review Yes No N/A* 

1 Application Form (EPA Form 8570-1)(link to form) signed & complete 

including package type )( 

Confidential Statement of Formula all boxes completed, form signed, and X dated (EPA Form 8570-4) (Link to form) 2 a) All inerts (link to http://www.epa.gov/opprdOOllinerts/), yes no 

including fragrances, approved for the proposed uses (see 

Footnote A) y 

3 Certification with Respect to Citation of Data (EPA Form 8570-34) (Link to X form) completed and signed (N/ A if 100% repack) 

Certificate and data matrix consistent -XIf applicant is relying on data that are compensable, is the offer yes no 

to pay statement included. (see Footnote B) 

]f ~nnlir~hl" is there a letter of Authorization for exclusive use only. 

Formulator's Exemption Statement (EPA Form 8570-27) (Link to form) X 4 completed and signed (N/ A if source is unregistered or applicant owns the 

tprhnira\) 

Data Matrix (EPA Form 8570-35) (Link to form) both internal and external 

copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% ~ .!epack) 

yes no 

!~~'&l~lt~ 5 _a) Selective Method (Fee i use) Xb) Cite-All (Fee category experts use) 

/;'~?f1 i;, 

c) Applicant owns all data (Fee category experts use) "iV' £/\ ,\.v;),: .'t'c"?;':,;;.-;;:.:, .,',: 

5 Copies of Label (link to httI!://www.eI!a.gov/oI!I!feadlllabelill!vlrmD 

6 (Electronic labels on CD are encouraged and guidance is available)( link to 

htlpJlwww.epa.gov/peslicides/regulaling/regislering/submissions/index.hlm#labels X 

) 

1 

77
7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) X 

Notice of Filing (link to 

8 htt[!://www.e[!a.gov/[!esticides/regulating£tolerance [!etitions.htm) included 

http://www.epa.gov/pesticides/regulating/tolerances.htm) 

with petitions (link to ~ 

9 If applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprdOOl/workplan/reducedrisk.html) X 

Required Data (link to 

htt[!://www.e[!a.gov/[!esticides/regulatinVdata reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included with application 

10 

2 

78
Comments: 

I «\ tOe u 

-JD 

o~ j\f-

* N/A - Not Applicable 

Footnotes 

A. During the 21 day initial content review, all CSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal uses, correcting 

mistakes on the CSF, etc. or 2) provide the data to support OPP approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

CSF and may require submission of data. All information, forms, data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period, otherwise, the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even if a product is currently registered by consulting the inert Web 

3 

79
site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an applicatiou 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (nAB) at inertsbranch@epa.gov and resolve the issue. Copies of the 

correspondence with nAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by IIAB. The nAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm ]. 

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional information such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included 

to enable the Agency to determine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If this option is selected and implemented, the Agency may 

request an extension in the PRlA decision review timeframe to accommodate 

the inert review/approval process; 

4 

80

site [link to http://www.epa.gov/opprdOOllinerts/lists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an applicatiou 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (nAB) at inertsbranch@epa.gov and resolve the issue. Copies of the 

correspondence with nAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by IIAB. The nAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm ]. 

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional information such as an alternate name of the inert, CAS number or other 

information [link to http://www.epa.gov/opprdOOllinerts/tips.pdf] must also be included 

to enable the Agency to determine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit information to the individual 

identified by the Agency when the applicant is informed of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSF, the Agency will contact the 

applicant with the following options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If this option is selected and implemented, the Agency may 

request an extension in the PRlA decision review timeframe to accommodate 

the inert review/approval process; 

4 
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

I. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

I. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 

81

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following options: 

I. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

I. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R301 or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 

82

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R301 or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 
~~''''i~O sr", 

" ,,; ft"'''' . 

$~ ~ " ~ \IU. ~ \"",~ ~ ~L PRd'i~v~ 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

lY~ (,1)/1 

August 30, 2010 

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT 

Or Pay On-Line at www.Pay.Gov (See Below for Details) 

OPP Decision Number: D-438361 

EPA File Symbol or Registration Number: 2517-RUE 

OFFICE OF 

PREVENTION. PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FOR DOGS 

EPA Receipt Date: II-Aug-20 I 0 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application for registration. If you 

submitted data with this application, the results of the PRN-86-5 screen will be communicated 

separately. During the administrative screen, the Office of Pesticide Programs has determined 

that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide 

Registration Improvement Act. 

The Action previously identified as R31 0 has been reclassified as Action Code: R320 

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE 

CITATIONS); 

The fee associated with this action is $ 5,712 (50% of$ 11,424). Payment in the amount of 

$ 2,289 has been received. Please remit additional payment in the amount of $ 3,423. 

By USPS: 

USEPA Washington Finance Center 

Pesticide Registration Service Fee 

PO Box 979074 

St. Louis, MO 63197-9000 

83

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

August 30, 2010 

PLEASE RETURN A COPY OF THIS LETTER WITH PAYMENT 

Or Pay On-Line at www.Pay.Gov (See Below for Details) 

OPP Decision Number: D-438361 

EPA File Symbol or Registration Number: 2517-RUE 

OFFICE OF 

PREVENTION. PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FOR DOGS 

EPA Receipt Date: II-Aug-20 I 0 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application for registration. If you 

submitted data with this application, the results of the PRN-86-5 screen will be communicated 

separately. During the administrative screen, the Office of Pesticide Programs has determined 

that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide 

Registration Improvement Act. 

The Action previously identified as R31 0 has been reclassified as Action Code: R320 

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE 

CITATIONS); 

The fee associated with this action is $ 5,712 (50% of$ 11,424). Payment in the amount of 

$ 2,289 has been received. Please remit additional payment in the amount of $ 3,423. 

By USPS: 

USEPA Washington Finance Center 

Pesticide Registration Service Fee 

PO Box 979074 

St. Louis, MO 63197-9000 
By Courier: 

U.S. Bank 

Government Lockbox 979074 

1005 Convention Plaza 

SL-MO-C2-GL 

St. Louis, MO 63197 

Telephone: (412) 236-2294 

All payments must be in United States currency by check, bank draft, or money order 

drawn to the order of the Environmental Protection Agency. To ensure proper credit, please 

write the OPP DECISION NUMBER on your check, and enclose a copy of this letter with your 

payment. 

Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund 

transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select 

"search by form name." From the next page, select "P," then click on "Pesticide Registration 

Improvement Act. Fee Payment" and complete the form, making certain to use the decision 

number and registration number on the invoice you receive from the Pesticide Program in the 

space provided. 

You may be eligible for a partial waiver of the registration service fee if, for example, you 

qualifY as a small business or are applying for a minor use, or if your application is solely 

associated with an IR-4 tolerance petition. Please be advised that if you intend to request a 

waiver, you must do so in writing within 15 days of receipt of this invoice instead of remitting 

the amount indicated above. OPP will not consider waiver requests after the registration service 

fee has been paid. Information regarding eligibility and how th request and document a fee 

waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticides/fees. 

Please send Registration Service Fee Waiver requests to: 

By USPS: 

Document Processing Desk (WAIVER) 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave NW 

Washington, DC 20460 

By Courier: 

Document Processing Desk (WAIVER) 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

Room S4900 Potomac Yard 1 

2777 S. Crystal Dr. 

Arlington, VA 22202 

84

By Courier: 

U.S. Bank 

Government Lockbox 979074 

1005 Convention Plaza 

SL-MO-C2-GL 

St. Louis, MO 63197 

Telephone: (412) 236-2294 

All payments must be in United States currency by check, bank draft, or money order 

drawn to the order of the Environmental Protection Agency. To ensure proper credit, please 

write the OPP DECISION NUMBER on your check, and enclose a copy of this letter with your 

payment. 

Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund 

transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select 

"search by form name." From the next page, select "P," then click on "Pesticide Registration 

Improvement Act. Fee Payment" and complete the form, making certain to use the decision 

number and registration number on the invoice you receive from the Pesticide Program in the 

space provided. 

You may be eligible for a partial waiver of the registration service fee if, for example, you 

qualifY as a small business or are applying for a minor use, or if your application is solely 

associated with an IR-4 tolerance petition. Please be advised that if you intend to request a 

waiver, you must do so in writing within 15 days of receipt of this invoice instead of remitting 

the amount indicated above. OPP will not consider waiver requests after the registration service 

fee has been paid. Information regarding eligibility and how th request and document a fee 

waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticides/fees. 

Please send Registration Service Fee Waiver requests to: 

By USPS: 

Document Processing Desk (WAIVER) 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave NW 

Washington, DC 20460 

By Courier: 

Document Processing Desk (WAIVER) 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

Room S4900 Potomac Yard 1 

2777 S. Crystal Dr. 

Arlington, VA 22202 
A PRIA decision time review period will not start until a fee waiver is granted and/or the 

Agency receives certification that the outstanding fee has been paid. If the Agency does not 

receive certification of payment for this action or a fee waiver request within the next 30 days, 

the Agency will presume that you no longer want to pursue this action. The Agency will then 

reject your application and issue an invoice for any applicable outstanding fees. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerely, 

& Resources Management Division 

( 

85
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

August 12, 2010 

OPP Decision Number: D-438361 

EPA File Symbol or Registration Number: 2517-RUE 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FOR DOGS 

EPA Receipt Date: II-Aug-2010 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Receipt of Application and 50% Small Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has received your application, 50% small business 

waiver request, and cerification of payment. If you submitted data with this application, the 

results of the PRN-86-5 screen will be communicated separately. During the administrative 

screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide 

Registration Service Fee as defined in the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R31 0 

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXICITY;PUBLlC HEALTH PEST EFFICACY); 

Your request for waiver has been forwarded for review. You will be notified in writing when a 

determination is made regarding your request. If your waiver request is approved, the decision 

review time period will start on the date of approval. If your waiver request is denied, you will 

receive an invoice for the outstanding balance. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerely, C2, 

J~u?ru~ Front End Processing Staff 

Information Technology & Resources Management Division 

86

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

August 12, 2010 

OPP Decision Number: D-438361 

EPA File Symbol or Registration Number: 2517-RUE 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FOR DOGS 

EPA Receipt Date: II-Aug-2010 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Receipt of Application and 50% Small Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has received your application, 50% small business 

waiver request, and cerification of payment. If you submitted data with this application, the 

results of the PRN-86-5 screen will be communicated separately. During the administrative 

screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide 

Registration Service Fee as defined in the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R31 0 

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXICITY;PUBLlC HEALTH PEST EFFICACY); 

Your request for waiver has been forwarded for review. You will be notified in writing when a 

determination is made regarding your request. If your waiver request is approved, the decision 

review time period will start on the date of approval. If your waiver request is denied, you will 

receive an invoice for the outstanding balance. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 308-9362. 

Sincerely, C2, 

J~u?ru~ Front End Processing Staff 

Information Technology & Resources Management Division 
:\~o S1"-'I'''''' ~""" 'c-;s., 

f~-- ,,; - " ~ 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

o '< 

~ ~ ~1-I'-i{ PR~t.O~ 

August 16,2010 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH l58TH PLAZA 

OMAHA, NE 68130-1703 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION. PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of ll-AUG-l O. Our staff has completed a preliminary 

analysis of the material. The results are provided as follows: 

Your submittal was found to be in full compliance with the standards for submission of 

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with 

Master Record ID's (MRlDs) assigned to each document submitted. Please use these numbers in 

all future references to these documents. Thank you for your cooperation. If you have any 

questions concerning this data submission, please raise them with the cognizant Product Manager, 

to whom the data have been released. 

87

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

August 16,2010 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION. PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of ll-AUG-l O. Our staff has completed a preliminary 

analysis of the material. The results are provided as follows: 

Your submittal was found to be in full compliance with the standards for submission of 

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with 

Master Record ID's (MRIDs) assigned to each document submitted. Please use these numbers in 

all future references to these documents. Thank you for your cooperation. If you have any 

questions concerning this data submission, please raise them with the cognizant Product Manager, 

to whom the data have been released. 
I 

IFee for Servicel (880182$-

This package includes the following for Division 

(!J New Registration 

o Amendment 

~Studies? ~ Fee Waiver? 

if 

Dvolpay 0/0 Reduction: SO Risk Mgr. [JQJ 

Receipt No. s-I 880182 

EPA File Symbol/Reg. No. 1 2517-RUE 

Pin-Punch Date: 1 8/11/2010 

D This item is NOT subject to FFS action. 

Action--eo""d-he .... :----,II Parent/Child Decisions: I 

Requested: I R310 

Granted: I R3 \ 0 

Amount Due: $ If;578 

Inert Cleared for Intended Use Uncleared Inert in Product 

Reviewer: __ ,,-01+-·-=-(M_~_· _____ _ Date: 't/J~JID 

Remarks: 

88
Regulatory Type: 'iProduct Registratio~ - 'Section 3 

Application Type: j New Registration 

company:pS17 

~ Fee For Service: r. jie'sl r NO';] 

3 Billable: C." Yes C No 

Risk Manager: JRegistr~.tion DivJsion',, Risk Manag~ment Team 10 3 

Producl #: 2517:RUE .!Producl Nome: ~ERGEANT'S FIPRONIL + CYPHENOTHRIN + ~ ~. -'---'-'-~ : ' ", ,: 

Me Too 

""SecliOn3: 

Me Too 

Product Name: 

fEW END·USE PRODUCT REGISTRATION APPliCATION 

89
FEE FOR SERVICE 

90
Pay.goy - Online Payment 

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.goy Tracking Information 

Application Name: PRIA Service Fees 

Pay.goy Tracking 10: 2510lM08 

Agency Tracking 10: 74122352649 

Transaction Date and Time: 06/18/201014:38 EDT 

Payment Summary 

Account Holder Sergeant's Pet Care Products, 

Name: Inc 

Payment Date: 06/21/2010 

Decision Number: 

Payment Amount: $2,289.00 Registration Number: 2517-new 

Page I of! 

1 1213 

Account Type: Business Checking 

Routing Number: 

Account Number: *****5483 

Company Name: Sergeant's Pet Care Produ 

Company Number: 2517 

Action Code: R310 

https:llwww.pay.goy/paygoy/payments/authorizeACHPayment.html 6/1812010 

91

Pay.goy - Online Payment 

Online Payment 

Step 3: Confirm Payment 

Thank you. 

Your transaction has been successfully completed. 

Pay.goy Tracking Information 

Application Name: PRIA Service Fees 

Pay.goy Tracking 10: 2510lM08 

Agency Tracking 10: 74122352649 

Transaction Date and Time: 06/18/201014:38 EDT 

Payment Summary 

Account Holder Sergeant's Pet Care Products, 

Name: Inc 

Payment Date: 06/21/2010 

Decision Number: 

Payment Amount: $2,289.00 Registration Number: 2517-new 

Page I of! 

1 1213 

Account Type: Business Checking 

Routing Number: 

Account Number: *****5483 

Company Name: Sergeant's Pet Care Produ 

Company Number: 2517 

Action Code: R310 

httPs://www.pay.goy/paygoy/payments/authorizeACHPayment.html 6/18/2010 

*Commercial/financial information may be entitled to confidential treatment*
Print Letter I I 

Enter More Information I 

Tracking 

92
;...Ind,: S:Utl E"1Y,;o t1t~. t.1'clr:tlo.~ ':"Olr,:~ 

QU!:4 01 P,lIJ(ICll ~;~~'l'nl 

Ir,fOI(:,.lllor F.fIOUJ: .. 1 ,AC ~':"""~fl :::"~'ll'O"! 

Ir,(Cdrn.lllon :";~Ii:t\ e.,jr,-=:-, 

SEPA 

.AD:'©lSTK-\TIVE No(s:),: 

, 

Plv1: _I_o ____ -c:--____ --'--_ 

C}IE~ATCAl No.: ____ ~_~ ____ _ 

The jacket for this action can be 

requested through the J.ACKETS S)'stem, 

93
UN. J STATES ENVIRONMENTAL PROTEClluNAGENCY 

WASHINGTON, D.C. 20460 

September 7,20 I 0 

OPP Decision Number: D-438361 

EPA File Symbol or Registration Number: 2517-RUE 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FOR DOGS 

EPA Application Receipt Date: II-Aug-20 I 0 

EPA Waiver Request Receipt Date: II-Aug-2010 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Approval of 50% SmaIl Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has approved your request for 50% waiver of the 

pesticide registration fee associated with the action referenced above. The decision review 

period for this action will begin on the date of this letter. 

The Action has been identified as Action Code: R320 

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTNE 

CITATIONS); 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman, at (703) 308-9362. 

Sincerely, 

JVl !~lJ~ I~~\ J .-;;n- \) 

Oscar Morales, Director 

Information Technology & Resources Management Division 

Office of Pesticide Programs 

94

UN. J STATES ENVIRONMENTAL PROTEClluNAGENCY 

WASHINGTON, D.C. 20460 

September 7,20 I 0 

OPP Decision Number: D-438361 

EPA File Symbol or Registration Number: 2517-RUE 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Product Name: SERGEANT'S FIPRONIL + CYPHENOTHRIN + METHOPRENE SQUEEZEON FOR DOGS 

EPA Application Receipt Date: II-Aug-20 I 0 

EPA Waiver Request Receipt Date: II-Aug-2010 

EPA Company Number: 2517 

Company Name: SERGEANT'S PET CARE PRODUCTS, INC. 

KELLY R. HOSKINS 

SERGEANT'S PET CARE PRODUCTS, INC. 

2625 SOUTH 158TH PLAZA 

OMAHA, NE 68130-1703 

SUBJECT: Approval of 50% SmaIl Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has approved your request for 50% waiver of the 

pesticide registration fee associated with the action referenced above. The decision review 

period for this action will begin on the date of this letter. 

The Action has been identified as Action Code: R320 

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTNE 

CITATIONS); 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman, at (703) 308-9362. 

Sincerely, 

JVl !~lJ~ I~~\ J .-;;n- \) 

Oscar Morales, Director 

Information Technology & Resources Management Division 

Office of Pesticide Programs 
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

August 11,2010 

Richard Gebken, PMlO 

Office of Pesticide Programs (7504P) 

u.s. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Certification 

Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs 

EPA File Symbol 2517 -NEW (Zv.(C; 

Dear Mr. Gebken: 

I certify that the packaging used for the following product meets the standards of 40 CFR 157.32, 

including the revised standards in 16 CFR 1700.15(b), when tested by the revised testing 

procedures in 16 CFR 1700.20, as published in 60 FR 37710 (July 21, 1995): 

• Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs (EPA File 

Symbol 2517-NEW) 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th Plaza, Omaha, NE 68130-1770, 

EPA Company Number 2517) is submitting this child resistant packaging certification to support 

for the new end-use product for Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On 

for Dogs (EPA File Symbol 2517-NEW). All product labels have language specifYing the use of 

scissors to open the product container and label language stating the product is not to be applied 

by children. 

If you have any questions, please contact me at 402-938-7079. 

Sincerely, 

~ .-e.. .~~ / t-Iti 

Kelly R~oskins Manager of Technical Affairs 

cc: Larry Nouvel 

95
Sergeant's Pet Care Products, Inc. 

2625 South 1581h Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com 

August 11,2010 

Rosalind Gross 

clo Richard Gebken 

Registration Division 

Office of Pesticide Programs (7504P) 

u.s. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Child Resistant Packaging Support 

Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs (EPA 

File Symbol: 2517-NfoW) (ZIJ}"" 

Dear Ms. Gross: 

Sergeant's Pet Care Products, Inc. (EPA Company Number 2517) is submitting a request to rely 

on previously submitted Child Resistant Packaging (CRP) studies to support this new 

registration. The CRP data were submitted to EPA on April 12, 20 lOin support of the pending 

registration applications under EPA File Symbols: 25 I 7-RGT, 2517-RGA, 25 I 7-RGL, and 

25 1 7-RGU (all of which contain Fipronil at 9.7-9.8%). 

Sergeant's generated CRP data on a standard white applicator in sizes 0.5, 0.67, 1.34,2.68, and 

4.02 mL. The following is a summary table of the applicators that were tested and submitted to 

EPA in the CRP data: 

Use Applicator Base Color Fill Weight (mL) Color 

Dog Up to 22 lbs White 0.67 Orange 

Dog 23-44 lbs White 1.34 Green 

Dog 45-88 lbs White 2.68 Red 

Dog 89-132Ibs White 4.02 Blue 

Cats All Weights White 0.50 Purple 

CRP data is required for this new product because of the inclusion of the active ingredient 

fipronil (9.8%) in the pet squeeze-on product. The CRP testing was conducted on a standard 

package size and color configuration for a product containing fipronil (9.8%). The Sergeant's 

Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs product being submitted today also 

contains fipronil at 9.8%. Additionally, Sergeant's already has dog squeeze-on products 

approved by EPA containing 20-30% cyphenothrin (EPA Registration Numbers 2517 -127 

through 2517-132) that are not subject to CRP. This new product contains 5% cyphenothrin and 

I 

96
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeanls.com 

8.8 % methoprene. Additionally, there are EPA registered products containing s-methoprene, 

none of which are subject to CRP. 

Furthermore, Sergeant's does not anticipate any additional toxicity through the combination of 

fipronil, cyphenothrin and methoprene. When Sergeant's Fipronil + Cyphenothrin + Methoprene 

Squeeze-On for Dogs is marketed, it will have the same applicator color (white) and fill weight 

colors per mL fill weight as was used in the submitted and referenced CRP testing. Based on 

available information, the density range of the pending products on which the CRP data were 

generated is the same as the new product (1.0-1.5 gr/cc). Therefore, Sergeant's is relying on 

MRID's: 48059803, 48059804, 48059805, and 48059806 to fulfill the CRP data requirements 

for Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs. 

If you have any questions, please contact me at 402-938-7079. 

Sincerely, 

~ B· t\obluy !7::f.--1 

Kelly R. Hoskins 

Manager of Technical Affairs 

cc: Larry Nouvel 

2 

97
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

August 11,2010 

Richard Gebken, PMlO 

Office ofpesticide Programs (7504P) (REGFEE) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs 

EPA File Symb(j125l7-:r~EWn,-<GDear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South l58th Plaza, Omaha, NE 68130-1770, 

EPA Company Number 2517) is submitting an EPA registration application for the new product 

Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs [containing the EPA 

registered active ingredients Fipronji (9.8%), Cyphenothrin (5.0%), and s-Methoprene (8.8%)]. 

Please find enclosed the following documentation in support of this registration: 

(1) Transmittal Document; 

(2) Application for Registration (EPA Form 8570-1); 

(3) Confidential Statement of Formula (EPA Form 8570-4) (two copies); 

(4) Certification with Respect to Citation of Data (EPA Form 8570-34); 

(5) Formulator's Exemption Statement (EPA Form 8570-27); 

(6) Data Matrix (EPA Form 8570-35) - EPA and Public Versions; 

(7) Product Label (five copies); 

(8) Letter of Authorization; 

'"(9) Child Resistant Package (CRP) Certification Statement; 

(10) Bridging Argument to Cite CRP Data; 

(11) Submission ofEP A Pesticide Registration Improvement Act InformatioJl; 

(12) Voluntary Small Business Certification Form; 

(13) PRlA Fee Waiver Certification Statement; 

(14) PRlA Fee Waiver Support Letter; 

(15) Recent EPA Approval of 50% Small Business Waiver Request (D-425455); 

(16) PRlA Category R3l 0, Payment Confirmation Receipt; and 

(17) Three Copies of Supporting Studies. 

The registration of Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs is a 

selective citation registration for a new end-use product. Sergeant's is submitting new product 

chemistry studies in support of this end-use product registration, and one new efficacy study. 

Additionally, Sergeant's is citing acute toxicity studies, companion animal safety data and 

efficacy studies submitted to EPA on June 18,2010 with the registration application for 

98
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs. The acute toxicity studies were 

conducted on a "soup" that contains multiple active ingredients that can be bridged across 

multiple formulated end-use products. 

This registration application is considered a PRIA Category R31 0 (new end-use product) with a 

PRIA review time of 6 months. Sergeant's submitted a PRIA Small Business Waiver Request 

under separate cover on April 14, 2010, and it was approved by EPA on May 4, 2010. A copy of 

this approval letter is enclosed. 

We look forward to working with the Agency to register Sergeant's Fipronil + Cyphenothrin + 

Methoprene Squeeze-On for Dogs. If you have any questions or need additional information 

regarding this registration application, please contact me at 402-938-7079. 

Sincerely, 

Kelly R. Hoskins 

Manager of Technical Affairs 

Enclosures 

99
Please read instructions on reverse bero ',mplelinf( form. Form Appro" ,. OMB No 20700060 - Approval expires 05-31 -98 

United States ~_Registration OPP Identifier Number 

EPA Environmental Protection Agency D_Amendment 

Washington, DC 20460 D Other 

Application for Pesticide - Section I 

1. CompanylProduct NUR~r ..- 2. EPA Product Manager 3. Proposed Classification 

2517-NEW I u. t::: Richard Gebken 

4. Company/Product (Name) 5.PM# 10 ~None DRestricted 

Sergeant's Pet Care Products, Inc.! Sergeant's Fipronil + 

Cyphenothrin + Methoprene Squeeze-On For Dogs 

5. Name and Address of Applicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(I), my 

Sergeant's Pet Care Products, Inc. product is similar or identical in composition and labeling to: 

2625 South 158th Plaza 

Omaha, NE 68130-1770 EPA Reg. No. 

Product Name 

o Check if this is a new address 

Section II 

o Amendment ~ Explain below. o Final printed labels in response to Agency letter dated XX-XX~XX 

o Resubmission in response to Agency letter dated XX~XX-XX o "Me Too" Application 

o Notitication ~ Explain below. ~ Other - Explain below. 

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

Submission of a new end-use product registration application. 

Section III 

1. Material This Product Will Be Packaqed In: 

Child~Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container 

~Yes' ~Yes DYes o Metal 

DNo o No ~ No r:g] Plastic 

If "Yes" No. per If "Yes" No. per DGlass 

'Certification must Unit Packaging wgt. Container Package wgt. Container 

DPaper be submitted 0.023 fl oz (0.67 ml) 

0.045 fl oz (1.34 ml) I 3 vials I DOther (Specify) pla,tic Bag 

0.091 fl oz (2.68 ml) 

0.136 fl oz (4.02 ml) • 

3. Location of Net Contents Information 4. Size(s) Retail Container 5. Location of Label Direct!'Jns 

r:g]Label o Container 0.067 ml, 1.34 ml, 2.68 ml, 4.02 ml DOn c~;.· 

[8]On Label:.l,'} accomr!'nyin:J product 

6. Manner in Which Label is Affixed to Product Duthograph ~Other 

DPaper glued 

DStenciled . 

Section IV . . . 

1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this appJicati~n'.) 

Name Title Telephone No. (Include Area Code) 

Kelly R. Hoskins Manager of Technical Affairs 402-938-7079 

Certification 6. Date Application 

I certify that the statements I have made on this form and all attachments thereto are true. accurate and complete. I Received 

acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both (Stamped) 

under applicable law. 

2. Signatur~ 

~lM"'5/MT 3. Title 

BY: ., c~ ~ Manager of Technical Affairs 

4. Typed Name: 5. Date: 08/11/2010 

Kelly R. Hoskins 

100
TRANSMITTAL DOCUMENT 

NAME AND ADDRESS OF SUBMITTER: 

Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza 

Omaha, NE 68130-1770 

CONTACT PERSON (Return to) 

Kelly R. Hoskins 

Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza 

Omaha, NE 68130-1770 

REGULATORY ACTION SUPPORTED BY THIS PACKAGE: 

This submission is prepared to support an EPA registration application for the new end-use 

product Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs. 

SUBMITTAL DATE: 

August 11,2010 

Volume Study Title MRIDNo. 

1 Administrative Materials 

2 Group A Product Chemistry for Sergeant's Fipronil + 

Cyphenothrin + Methoprene Squeeze-On for Dogs 

3 Group B Product Chemistry for Sergeant's Fipronil + 

Cyphenothrin + Methoprene Squeeze--On for Dogs 

4 Dose Titration with S-Methoprene Squeeze-Ons on Dogs 

Measuring Flea Egg Sterilization. ~ 

101
Form approved. OMS No. 2070-0060, 2070-0057, L'J/0-0107, 2070-0t22, 2070-0t64. 

& EPA 

United States 

Environmental Protection Agency 

Washington, DC 20460 

Formulator's Exemption Statement 

(40 CFR 152.85) 

Applicant's Name and Address EPA FiI~/Registration Number 

Sergeant's Pet Care Products, Inc. 2517- R\ft..& 

2625 South 158th Plaza Product Name 

Omaha, NE 68130-1770 Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for 0 

Date of Confidential Statement of Formula (EPA Form 8570-4) 

0811112010 

As an authorized representative of the applicant for registration of the product identified above, I certify that: 

(1) This product contains the following active ingredient(s): 

Fipronil 

S-methoprene 

Cyphenothrin 

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing, 

formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by 

us from another person and meets the requirements of 40 CFR section t58.50{e){2) or (3). 

(3) Indicate by checking (A) or (8) below which paragraph applies: 

71 (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. 

That formula statement indicates, by company name, registration number, and product name, the source of the active ingredient{s) listed in 

paragraph ttl. 

OR 

I (8) The Confidential Statement of Formula (CSF)(EPA Form 8570-4) referenced above and on file with the EPA is complete, current, an 

accurate and contains the information required on the current CSF. 

(4) The following active ingredients in this product qualify for the formulator's exemption. 

Source 

Active Ingredient Product Name Registration Number 

Fipronil 

S-methoprene 

S-methoprene 

Cyphenothrin 

~~. 'tlP~~s.J W+ r 

Name and Title Date 

Kelly R. Hoskins, Manager of G 0811112010 

EPA For~570'27 (Rev. 06·2004)' Copy 1 EPA 

Copy 2 ·A ppllcant copy 

102 *Product ingredient source information may be entitled to confidential treatment*
Form Approved OMS Nos. 2070-0060; 2070-0057; 2070-0107; 2070-0122; 2070-0164 

",,"'''',<, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ( "" , ... 

S:Z' ,,,,,,,,,,# 1200 Pennsylvania Avenue, N.W . 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The P-Jblic reporting burden for this collection of information isestimated to avernge 1.25 hours per response for registration 

and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send 

comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the blU'den to: Director, Collection 

Strategies Division (2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. Do not send the completed form 

to this address, 

Certification with Respect to Citation of Data 

Applicanfs/ReQistranfs Name, Address, and Telephone Number EPA ReQistration Number/File Symbol 

Sergeant's Pet Care Products, Inc., 2625 South 158th Plaza, Omaha, NE 68130-t770 2517-NEW 

Adive InQredient(s) and/or representative test compound(s) Date 

Fipronil , Cyphenothrin , and S-methoprene 08/111/2010 

General Use Patem(s) (list aU those claimed for this product usinQ 40 CFR Part 158) Product Name 

Domestic indoor non-food Sergeant's Fipronil + Cyphenothrin + Methoprenefi 

NOTE: If your produd is a 100% repackaging of another purchased EPA-registered produd labeled for aD the same uses on your label, you do not need to 

submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27). 

D I am responding 10 a Data-Call-In Notice, and have induded with this form a list of companies sent offers of compensation (the Data Matrix form should 

be used for this purpose). 

SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

D I am using the cite-all method of support, and have induded with this form [2] I am using the seledive method of support (or cite-all option 

a list of companies sent offers of compensation (the Data Matrix form under the seledive method), and have induded with this form a 

should be used for this purpose). completed list of data requirements (the Data Matrix form must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

[Required if using the cite-all method or when using the cite-all option under the seledive method to satisfy one or more data requirements) 

D I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA 

SECTION Ill: CERTIFICATION 

I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or cited in the 

application for registration, the form for reregistration, or the Data-Call-In response. In addition, if the cite-all option or cite-all option under the selective method is 

indicated in Sedion I, this application is supported by all data in the Agency's files that (1) concem the properties or effects of this product or an identical or 

substantially similar produd, or one or more of the ingredients in this produd; and (2) is a lype of data that would be required 10 be submitted under the data 

requirements in effed on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and 

uses. 

I certify that for ead! exdusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have obtained 

the written permission of the original data submitter to cite that study. 

I certify that for each study cited in support of this registration or reregistration that is not an exdusive use study, either: (a) I am the original data 

submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for 

compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have 

offered (I) to pay compensation to the extent required by sedions 3(c)(1)(F) and/or 3(c)(2)(8) of FIFRA; and Qi) to commence negotiations to determine the 

amount and terms of compensation, if any, to be paid for the use of the study. 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in 

accordance with sedions 3(c)(1)(F) andlor 3(c)(2)(8) of FIFRA are available and will be submitted to the .t\gency upon request. Shoud I fail to produce such 

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with 

FIFRA. 

I certify that the statemenls I haw made on this form and all attachments to it are true, accurae, and complete. I acknovJedge that any 

knowingly false or misleadirg statement may be punishable I¥ fine or imprisonment or both under applicable law. 

Signature 

~~ 'L- fu, 'i, lAA 1\:& }2dt-T 

Date Typed or Printed Name and TItle 

08/11/2010 Kelly R Hoskins, Manager of Technical Affairs 

EPA Fonn 8570-34 (12~2003) EledronlC and Paper versIOns available. Submit only Paper version. 

103
R 310 

Must submit Group A and B product chemistry data for each proposed product. 

End Use (EP) or Manufacturing Use (MP) product or Technical Grade of the Active Ingredient (TGAI) 

EP Data MP Data 

Guideline Group A: Product Chemistry Data Submitted Submitted TGAI 

No. Study Title Yes No Yes No Yes No 

830.1550 Product Identity & Composition / 

Description of materials used to 

/ 830.1600 produce the product 

830.1650 Description of formulation process V 

830.1670 Discussion on the formation of impurities / 

830.1700 Preliminary. analysis ~ 

,/ 

830.1750 Certified limits (158.345) V 

830.1800 Enforcement analytical method ( lis L:c! Cl (' ; : :., j/ 

J 

EP Data MP Data 

Guideline 

No. 

Group B: Product Chemistry Data Study ~~!1)!~~J-j!~!1)!~~~~~-~ 

Title 

II 

Grayed out = data not required 

1 

104
R 310 

New products must either: 1) supply the product specific acute toxicity 6 pack data (listed below), 

or 2) provide a bridging rationale document. The bridging document directs OPP to use a currently 

registered set of 6 acute toxicity data and label; instead of submitting product specific data. 

Data 

Guideline Acute toxicity (6 pack) submitted Cited 

No. Study Title Yes No Yes No 

870.1100 Acute Oral (LD50) ,/ 

870.1200 Acute Dermal (LD50) ,/ 

870.1300 Acute Inhalation (LC50) ./ 

870.2400 Acute Eye Irritation / 

870.2500 Acute Derrnallrritation ./ 

870.2600 Dermal Sensitization / 

Efficacy - which guideline is used depends on the proposed label use 

Data 

Guideline submitted Cited 

No, Study Title Yes No Yes No Comments 

810.3100 Soil Treatments for Imported Fire Ants 

Livestock, Poultry, Fur and Wool-Bearing 

810.3200 Animal Treatments 

Treatments to Control Pests of Humans 

and ,/ 

810.3300 Pets 

Mosquito, Black Fly, and Biting Midge 

810.3400 (Sand Fly) Treatments 

810.3500 Premises Treatments 

810.3600 Structural Treatments 

Methods for Efficacy Testing ofT ermite 

810.3800 Baits 

2 

105
Form Appro\'ed OMB 1\'0.2070·0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0,25 hours per response for reregistration 

and special review activities, including time for reading the instruction and completing the necessary forms. Send commel1s regarding the burden estimate or any other aspect of this collection of information, including 

suggestions for redu::ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protectioo Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this 

address. 

DATA MATRIX 

Date: August II, 2010 EPA Reg No.lFile Symbol 25 I 7-l:JF;W J2v. e Page I of 4 

Applicant's/Registrant's Name & Address Product: Sergeant's Fipronil + Cyphenothrin + 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs 

Ingredients: Fipronil, Cyphenothrin and (s)-Methoprene 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter I Status Note 

830.1550,830.1600,830.1620, Group A Product Chemistr), for Sergeant's Fipronil + Cyphenothrin + New submission Sergeant's Pet Care Products, Inc. OWN 

830.1650,830.1670, 830.1750 Methoprene Squeeze-On for Dogs 

830.1800 Enforcement analytical method 48122601 Sergeant's Pet Care Products, Inc. OWN 

830.6302,830.6303, 830.6304, Group B Product Chemistry for Sergeant's Fipronil + Cyphenothrin + New submission Sergeant's Pet Care Products, Inc. OWN 

830.6313, 830.6314, 830.6315, Methoprene Squeeze-On for Dogs 

830.6316,830.6317,830.6319, 

830.6320,830.6321,830.7000, 

830.7100,830.7300,830.7520 

830.6317,830.6320 Storage stability and corrosion characteristics To Be Submitted Sergeant's Pet Care Products, Inc. OWN 

Upon Completion 

870.1100 Acute Oral Toxicity Up and Down Procedure with Dog Products 48129603 Sergeant's Pet Care Products, Inc. OWN 

870.1200 Acute Dermal Toxicity (Limit Test) with Dog Products 48129604 Sergeant's Pet Care Products, Inc. OWN 

870.1300 Waiver Request of Requirement for Further Testing for Acute 48129605 Sergeant's Pet Care Products, Inc. OWN 

Inhalation Toxicity 

870.2400 Acute Eye Irritation/Corrosion with Dog Products 48129606 Sergeant's Pet Care Products, Inc. OWN 

870.2500 Acute Dermal Irritation/Corrosion with Dog Products 48129607 Sergeant's Pet Care Products, Inc. OWN 

870.2600 Test for Sensitization (Guinea Pig Maximisation Test) with Dog 48129608 Sergeant's Pet Care Products, Inc. OWN 

Products 

870.7200 Companion Animal Safety for Sergeant's Fipronil + Cyphenothrin 48129614 Sergeant's Pet Care Products, Inc. OWN 

Squeeze-On for Dogs 

870.7200 Companion Animal Safety Study in Dogs - Cyphenothrin-IGR Spot- 46166108 Sergeant's Pet Care Products, Inc. OWN 

On for Dogs, 

870,7200 Companion Animal Safety Evaluation on Drop of Spot-On Products 47849609 Sergeant's Pet Care Products, Inc. OWN 

Containing Multiple Toxicants and Insect Growth Regulators. 

870.7200 Assessment of Tolerance of aO.25% RM 1601 Spray Formulation in 43121110 Merial Limited OLD 

Dogs at 3,9, and 15 mllkg When Applied 6 times to the Haircoat at 28 

Dl].)' Intervals 

Signature: 

~ tlo:)i.u'-'{ /2-i}r Name and Title Date (12- Kelly R. Hoskins, Manager of Technical Affairs 08111/2010 

EPA JOP.!. "" Fo ~~7n...1 5 (9.97) Elee . _ .. ~n .. " .' ..•... " ..... ~ .. L .'. _ ... " " Iy P~P' 

• ____ .. '_0 ____ • ,, __ r" __ •• 

gency py 

106
Form Approvcd OMB No. 2070-0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

" 401 M Street, S.W. 

" WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration 

and speciaJ review activiies, including time for reading the in2eregistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other ~ect of this collection of information, including 

suggestions for redu::ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protectioo Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this 

address. 

DATA MATRIX 

Date: August II, 2010 EPA Reg No.!File Symbo12517-NEW Page 2 of4 

Applicant'sfRegistrant's Name & Address Product: Sergeant's Fipronil + Cyphenothrin + 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs 

Ingredients: Fipronil, Cyphenothrin and (s)-Methoprene 

Guideline Reference Number Guideline Study Name MRlDNumber Submitter Status Note 

870.7200 Domestic Anima! Safety: Assessment of the Tolerance ofa 0.25% RM 43121111 Merial Limited OLD 

160 I Spray in Nursing Puppies Administered Twice at a 28 Day Interval 

at a Dose Rate of 6 mllkg: 

870.7200 Domestic Animal Safety Study ofRM1601C Topical Spray (Frontline 43444905 Merial Limited OLD 

Spray Treatment) in Juvenile Dogs: 

870.7200 Discussion in Support of Bridging Domestic Animal Safety Data on 43577711 Merial Limited OLD 

Frontline Spray Treatment to Frontline Spot Treatment Data Package. 

870.7200 Domestic Animal Safety Study by Topical Administration to Dogs: 43863802 Merial Limited OLD 

Fipronil Spot Treatment (RM 1601E) 

810.3300 Dose Titration with (S)-Methoprene Squeeze-Ons on Dogs Measuring New submission Sergeant's Pet Care Products, Inc. OWN 

Flea Egg Sterilization. " SI'B,\2.0;' 

810.3300 Overview and Summary ofFipronillCyphenothrin Dog Efficacy for 48129609 Sergeant's Pet Care Products, Inc. OWN 

Sergeant's Fipronil + Cyphenothrin Squeeze-On for Dogs 

810.3300 Immediate Efficacy ofa Combined Application of Frontline Plus with 48129610 Sergeant's Pet Care Products, Inc. OWN 

Cyphenothrin as a Squeeze-on against Fleas (Ctenocephalides felis) and 

Ticks (Rhipicephalus sanf!.Uineus) on Dogs MS 164 D 

810.3300 Immediate Efficacy Following Application of Frontline Plus with 48129611 Sergeant's Pet Care Products, Inc. OWN 

Cyphenothrin Squeeze-on against Fleas (Ctenocephalides felis) and Ticks 

(Rhipicephalus sanf!.Uineus) on Dogs MS 183 D 

810.3300 Immediate Efficacy Following Application of Frontline with 48129612 Sergeant's Pet Care Products, Inc. OWN 

Cyphenothrin Squeeze-on against Fleas (Ctenocephalides felis) and Ticks 

(Rhipicephalus sanguine us) on Dogs MS 175 D 

810.3300 Comparative efficacy evaluation of Sergeant's Squeeze-on and Frontline 48129613 Sergeant's Pet Care Products, Inc. OWN 

Plus for the treatment of adult cat flea (Ctenocephalides felis) and tick 

(Haemaphysalis elliptica, Rhipicephalus sanguineus and Dermacentor 

variabilis) infestations on dogs 

810.3300 A Dose Titration Study to Detennine the Optimal Spray Concentration of 43121114 Merial Limited OLD 

RM 1601 for Long Tenn Control of the Cat Flea Ctenocephalides felis 

and tile Brown Dog Tick Rhipicephalus sanguineus in the Dog 

Signature: 

~ \\oS~~5 I :'2;-11-T 

Name and Title Date 

12- Kelly R. Hoskins, Manager of Technical Affairs 0811 1/2010 

EPA Fonn 8570.35 (9-97) Electronic and Paper Versions Available <:"h.,.", nnl- ,,- y Papel - ._._--_. ,,-- .... - gCIICY py 

107
Form Approved OMB No. 2070-0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

" 401 M Street, S.W. 

'" WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration 

and special review activiies, including time for reading the in3eregistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other a~ect of this collection of infonnation, including 

suggestions for redl£ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this 

address. 

DATAMATRlX 

Date: August II, 20 IO EPA Reg No./File Symbol 25 I 7-NEW Page 3 of 4 

Applicant'siRegistrant's Name & Address Product: Sergeant's FipronU + Cyphenothrin + 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs 

Ingredients: Fipronil, Cyphenothrin and (s)-Methoprene 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 

810.3300 Product Performance: A Dose Confirmation Study to Verify the 43121115 Merial Limited OLD 

Optimal Spray Concentration ofRM 1601 for Long Residual Control 

of the Cat Flea (Ctenocephalides felis) and the Brown Dog Tick 

(Rhipicephalus sanguineus) in the Dog 

810.3300 A Comparative Evaluation of Two Treatment Regimes Using RM 1601 43121116 Merial Limited OLD 

Spray for Control of the Cat Flea Ctenocephalides felis on the Dog: 

810.3300 Laboratory Evaluation of RM 160 I Spray for Control Dermacentor 43121117 Merial Limited OLD 

variabilis and Rhipecephalus sanguineus on the Dog 

810.3300 An Investigation Study to Evaluate the Effect of Bathing of 43121118 Merial Limited OLD 

Laboratory Dogs on the Efficacy ofRMI601 Spray 

810.3300 Efficacy ofRMI60lC at 3 ml/kg and 6 mllkg Against Ixodes 43121122 Merial Limited OLD 

scapularis/dammini Nymphs, Dermacentor variabilis Nymphs, 

Amblyomma americanum Nymphs, Rhipicephalus sanguineus 

Nymphs, and Ctenocephalides felides Adults Using Treated Dog Hair 

as the Testing Substrate 

810.3300 Positive Referenced and Untreated Controlled, Confirmatory 43577712 Medal Limited OLD 

Laboratory Trial of RMI60lE SPOT-ON Formulation Applied to Dogs 

as 3 Weight Class Defined Volumes for the Control of the Cat Flea 

Ctenocephalides felis, the Brown Dog Tick Rhipicephalus sanguineus, 

and the American Dog Tick Dermacentor variabilis 

810.3300 Study Summaries: Frontline Plus For Dogs. 45612701 Medal Limited PAY 

810.3300 An Efficacy Study of Frontline Spray, Frontline Top Spot, and ML- 45620501 Merial Limited PAY 

2,095,988 509T, for the Treatment and Control of Trichodectes canis in 

the Dog 

810.3300 PR & D 0024101: Frontline Spray/ Frontline Spot-OnIML-2, 095, 988 45620504 Medal Limited PAY 

509TIDogs /Solutionrropical 

810.3300 PR & D 0052301 :Frontline Spray/Frontline Spot-OnIML-2, 095, 988 45620505 Medal Limited PAY 

509T/Dogs/ Solution! Topical 

810.3300 Frontline Spray & Top Spot! Dogs/Solutionffopical CliniallDose 45620506 Medal Limited PAY 

Confirmationl Ectoparasites, Mites, Sarcoptes Scabiei var canis 

Signature: \L-~ y~. I?--A-r 

Name and Title Date 

t\.oe;!.L\V-S Kelly R. Hoskins, Manager of Technical Affairs 0811 I120IO 

EPA Form 8S7()")S (9-97) Electronic and PJpcr Vcrsions AVJilable. Submit only Paper version Agency rnurn~1 Usc Copy 

108
Form Approved OMB No. 2070·0060 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

" 401 M Street, S.W. 

" WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration 

and special review activiies, including time for reading the in4eregistrationcompleting the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of infonnation, including 

suggestions for redu::ing the burden to Director: OPPE Information Management Division (2137) U.S. Environmental Protectioo Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the fonn to this 

address. 

DATA MATRIX 

Date: August 11,2010 EPA Reg No.lFile Symbol 2517-NEW Page 4 of 4 

Applicant'slRegistrant's Name & Address Product: Sergeant's Fipronil + Cyphenothrin + 

Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha, NE 68130-1770 Methoprene Squeeze-On for Dogs 

Ingredients: Fipronil, Cyphenolhrin and (s)-Methoprene 

Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 

810.3300 Study to Confirm the Efficacy ofFipronii Against Lice in Dogs Under 45628201 Merial Limited PAY 

Field Conditions 

810.3300 A Study to Evaluate the Efficacy of Frontline Plus for Control of 45866902 Merial Limited PAY 

Mosquitoes, Aedes aegypti, on Dogs 

810.3300 Effect of Shampoo Application after Treatment with a Cyphenothrin 46298501 Sergeant's Pet Care Products, Inc. OWN 

Squeeze-On on Efficacy Against Cat Fleas (Ctenocephalides felis), 

Adult Brown Dog Ticks (Rhipicephalus sanguineus) on Dogs 

40 CFR Part 157.32 Evaluation of the Dog Squeeze On 0.67 ml White Applicator with 48059803 Sergeant's Pet Care Products, Inc. OWN 

Orange Label Indicator (3x), scissors to open - F=I as a Poison 

Prevention Package for Sergeant's Pet Care Products, Inc. 

40 CPR Part 157.32 Evaluation of the Dog Squeeze On 1.34 ml White Applicator with 48059804 Sergeant's Pet Care Products, Inc. OWN 

Green Label Indicator (3x), scissors to open - F=l as a Poison 

Prevention Package for Sergeant's Pet Care Products, Inc. 

40 CFRParl 157.32 Evaluation of the Dog Squeeze On 2.68 ml White Applicator with Red 48059805 Sergeant's Pet Care Products, Inc. OWN 

Label Indicator (3x), scissors to open - F=l as a Poison Prevention 

Package for Sergeant's Pet Care Products, Inc. 

40 CFR Part 157.32 Evaluation of the Dog Squeeze On 4.02 ml White Applicator with Blue 48059806 Sergeant's Pet Care Products, Inc. OWN 

Label Indicator (3x), scissors to open - F=l as a Poison Prevention 

Package for Sergeant's Pet Care Products, Inc. 

Signature: 

~ t\-ostuy ( ~t:t+1 Name and Title Date 

~ Kelly R. Hoskins, Manager of Technical Affairs 0811 112010 

EPA Form 857{)..35 (9-97) Electronic and Paper Versions Available. Submit only I'aper versio "a~n~ .. r .. ,~~ .. ~l l1u C"nn .. geRCY py 

109
",ergeant's® Master LaL.~1 

II August 2010 Version 10.1 EPA Reg. No. 2517-XX 

Information in [ ] is optional. Page 1 of 8 

[CARTON LABEL - DRAFT MASTER LABEL COPY] 

Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On 

for Dogs 

[ABNs] 

[(Sergeant's®) (Sentry®) VetSpofl'M (Spot On) for dogs] 

[(Sergeant's®) (Sentry®) VetSpotTM (Spot On) for dogs] 

[(Sergeant's~ (Sentry~ FRONTIER GOLD (Spot On) for dogs] 

[(Sergeant's®) (Sentry®) EctoadvanceTM (Spot On) for dogs] 

. . ...../ ... i' .• , ....·hqG.~riu~~iE'·PN 

FIPR()NILt.CYPREN()tHB.fN';'·MEIDiJq.~B.EN~ 

[Apply to puppies over 12 weeks old] 

[Apply to puppies 12 weeks or older] 

[. Plea & Tick Control for Dogs & Puppies 12 weeks old and older] 

[·Por Dogs and Puppies 12 weeks of age or older] 

[·Por Dogs [up to 22Ibs], [23-44Ibs], [45-88Ibs], [89-132Ibs] 

[·Kills fleas (in as little as I hour), flea eggs, ticks (in as little as 1 hour), ckewing I';ct-'& 

mosquitoes] 

[·Kills (and Repels) Pleas, Ticks and Mosquitoes] 

[·Controls flea reinfestation for up to [16 weeks II 

[·Past Acting] 

[·Kills ticks (in as little as 1 hour)] 

[. Kills ticks including those that may transmit Lyme disease] 

[·Dogs can be bathed 24 hours after treatment] 

[. Waterproof] 

[ • Long Lasting] 

[·Research demonstrates that [brand name] kills adult fleas (in as little as 1 hour), flea 

eggs, flea larvae and pupae for up to four months.] 

[. [brand name] prevents development of all flea stages for up to four months.] 

[·Kills fleas (in as little as I hour), ticks (in as little as 1 hour), mosquitoes, (chewing) 

lice, flea eggs, larvae and pupae] 

[·Prevents all flea stages (adult fleas (in as little as I hour), flea eggs, flea pupae and flea 

larvae)] 

[. If dog is a high risk for flea re-infestation a once month application may be needed] 

[·Once a month treatment is recommended] 

[·A once monthly application is recommended for chewing lice,] 

[. Rapidly eliminates infestations with chewing lice] 

[·Monthly flea, tick, mosquito, lice, and flea egg protection] 

[·Monthly flea, tick, mosquito and lice protection] 

[·Kills flea eggs [larvae] [pupae] for up to 4 months] 

[·Aids in Control ofSarcoptic Mange] 

110
~ergeant's® Master Lak..d 

II August 2010 Version 10.1 EPA Reg. No. 2517-XX 

Information in [ ] is optional. Page 2 of 8 

[·Kills fleas (in as little as I hour), ticks (in as little as I hour), mosquitoes, flea eggs, and 

lice] 

[·[Seven] [7] Way Protection [Kills fleas (in as little as 1 hour), ticks (in as little as 1 

hour), mosquitoes, lice, flea eggs, flea larvae and flea pupae]] 

[·6 [Six] Way Protection! Kills fleas (in as little as 1 hour), ticks (in as little as I hour), 

mosquitoes, lice, flea eggs & flea larvae] 

[. [4 Week] [Flea and Tick & Treatment] 

[. [Four (4) Week] [Flea, Tick, Mosquito and Lice Control] 

[. With (S)-methoprene Insect Growth Regulator which Breaks the Flea Life Cycle] 

[. With (S)-methoprene to Break Flea Life Cycle] 

[. With Insect Growth Regulator to Break Flea Life Cycle] 

[. Triple Action [!]:Fipronil and Cyphenothrin with (S)-methoprene IGR Effectively 

Breaks the Flea Life Cycle] 

[. Triple Action [I]: Effectively Breaks the Flea Life Cycle[!]] 

[. Three Applications {for cartons with 3 applicators}] and/or [3 Month Supply] or [12 

Week Supply] 

[. Best ifused year round!] 

[. Kills & Repels Fleas (in as little as I hour) Up to [ 4 weeks]!] 

[. (ICON Showing 4 Week Protection)] 

[·4 Week Dose!] 

[. I Month Dose!] 

[. Easy to Use Application] 

[. Specially Formulated for Dogs and Puppies] 

[. [Free] Calendar Stickers Inside!] 

[. [Free] Brochure Inside!] 

[. [Free] Brochure and Calendar Stickers Inside] 

[. Patented Technology] 

[. Kills Flea Eggs & Flea Larvae for [(4 months)]!] 

[. Prevents Flea Eggs From Developing Into Biting Adults] 

[. Kills Ticks (in as little as 1 hour) for Up to [4 weeks]!] 

[. Kills [all stages of] Deer Ticks (vector of Lyme Disease) for up to 4 weeks] 

[. Kills Ticks (in as little as 1 hour)] 

[. Kills Ticks including Deer Ticks for up to 4 weeks] 

[. Kills Brown Dog Ticks (in as little as 1 hour)] 

[. Kills [Brown], [American,] [and Lone Star] Dog Ticks for up to 4 weeks] 

[. Kills Rhipicephalus sanguine us for up to 4 weeks] 

[·When used monthly [brand name] completely breaks the flea life cycle and controls tick 

and chewing lice infestations.] 

[. Kills American Dog Ticks [(Dermacentor variabilis)] for up to 4 weeks!] 

[. Apply once every [4 weeks]!] 

[·4 weeks Flea and Tick Treatment!] 

[ ·Once A Month Flea and Tick Treatment] 

[. Kills & Repels Fleas (in as little as I hour) and Ticks (in as little as I hour) for up to 4 

weeks!] 

[. Kills all stages of the flea life cycle] 

[. Kills Fleas (in as little as 1 hour), Ticks (in as little as I hour), Flea Eggs & Flea 

Larvae for up to 16 Weeks] 

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[. [Kills mosquitoes II 

[. Dogs can be bathed 24 hours after squeeze-on is applied] 

[. Prevents and controls reinfestations] 

EPA Reg. No. 2517-XX 

[. [Free with purchase] [Free inside] Monthly Application Reminder [Magnet] [clip] 

[ cardll 

[For Dogs & Puppies (12 weeks or older and) up to 22 Ibs.] 

[For Dogs 23-44 lbs.] 

[For Dogs 45-88 Ibs.] 

[For Dogs 89-132 Ibs.] 

[ ] - Denotes Optional Statements and/or Images that May be Used on Front, Back 

or Side Label Panels 

[Ingredient Statement may be on front or back label] 

ACTIVE INGREDIENTS: 

Fipronil. ......................................................................... 9.8% 

Cyphenothrin ................................................................. 5.0% 

(S)-methoprene ............................................................. 8.8% 

OTHER INGREDIENTS: ........................................ 76.4% 

TOTAL: 100.0% 

KEEP OUT OF REACH OF CHILDREN 

WARNING 

See [Back][ or ][Side] [Label Panel[ s] [ or] [insert] for Additional Precautionary Statements 

NET CONTENTS: 

Contains (3) [0.023 fl oz] [0.67 ml] applicators 

Contains (3) [0.045 fl oz] [1.34 ml] applicators 

Contains (3) [0.091 fl oz] [2.68 ml] applicators 

Contains (3) [0.136 fl oz] [4.02 ml] applicators 

112
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, ,,' ", ,",:,fjOGSQUEEZifON FIJ>lWNIL+CYPHENOTII~+METHOP@'.N1t 

[BACK/SIDE CARTON LABEL - MASTER LABEL] 

[brand name] contains Fipronil, cyphenothrin, and the insect growth regulator (lOR) (S)-

methoprene,to effectively kill [and repel] Fleas [(in as little as I hour)], Ticks [(in as little as I 

hour)], and kills mosquitoes and (chewing) lice, The active ingredients in [brand name] work by 

collecting in the hair follicles and skin oils, This product features a sustained-release formula that 

discharges from the animal's hair follicles using the natural skin oils, resulting in fast acting [and 

long lasting] control of Fleas and Ticks [(in as little as] hour)], [and kills mosquitoes] and 

chewing lice [for 30 days], 

[diagram with visual of fipronil collecting and being released from hair follicle] 

READ ENTIRE LABEL BEFORE EACH USE. 

USE ONLY ON DOGS AND PUPPIES OVER 12 WEEKS OF AGE. 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS. WARNING. Causes substantial 

but temporary eye injury, Do not get in eyes or on clothing, Wash thoroughly with soap and 

water after handling and before eating, drinking, chewing gum, or using tobacco, Remove and 

wash contaminated clothing before reuse, Harmful if swallowed, Harmful if absorbed through 

skin, Prolonged or frequently repeated skin contact may cause allergic reactions in some 

individuals, 

FIRST AID 

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 control center or doctor for further treatment advice, 

If On Skin • Take off contaminated clothing, 

Or Clothing • Rinse skin immediately with plenty of water for 15-20 minutes. 

• Call a poison control center or doctor for treatment advice, 

If Swallowed • Immediately call a poison control center or doctor. 

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

• Have person sip a glass of water if able to do so. 

• Do not give anything by mouth to an unconscious person, 

HOT LINE NUMBER 

Have the product container or label with you when calling a poison control center or doctor, or going 

for treatment. For more information on this pesticide product (including health concerns, medical 

emergencies or pesticide incidents), you may call 1-800-781-4738, 

NOTE TO PHYSICIAN OR VETERINARIAN 

Treat patient symptomatically 

113
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EPA Reg. No. 2517-XX 

.. .•... . . . ...... DQ~SQJJE,E:ZE QN .Fi~RONIL+CYPHENOTHRIN+ME'J.'HQPRENE 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 

READ ENTIRE LABEL [AND ENCLOSED DIRECTIONS] BEFORE EACH USE. 

DO NOT USE ON CATS. May be toxic and potentially fatal if applied to or ingested by cats. 

FOR EXTERNAL USE ON DOGS ONLY. Do not use on puppies under 12 weeks of age. 

Weigh your dog to be sure you are applying the right dose formulated for the weight of your pet. 

Do not treat your pet with more than one pesticide product at a time. Over dosing your animal 

can result in serious illness and even death. Best if used year round. Certain medications can 

interact with pesticides. Consult a veterinarian before using this product on debilitated, aged, 

medicated, pregnant, or nursing dogs. Consult a veterinarian before using on dogs with known 

organ dysfunction. DO NOT USE ON CATS or animals other than dogs. Separate the treated 

dog from all other dogs and cats for 24 hours after treatment has been applied. Cats and dogs that 

actively groom or engage in close physical contact with treated dog may be at risk of serious 

harmful effects. The most common signs of ingestion are excessive salivation and foaming at 

the mouth. If these symptoms occur immediately feed your dog and continue to monitor your 

pet for the next 24 hours. If symptoms persist call 1-800-781-4738 to talk to a veterinarian. Cats 

exhibiting these same symptoms from ingestion should be taken to the veterinarian immediately. 

If your dog is exhibiting signs of andlor are being treated for skin dermatitis, talk to your vet 

before applying any topical flea and tick control product. 

Sensitivities may occur after using ANY pesticide product on pets. If signs of sensitivity 

occur bathe your dog with a mild soap and rinse with large amounts of water. If signs 

continue, consult a veterinarian immediately by calling 1-800-781-4738. 

[ {Outer Packaging or Insert Copy} ] 

How to open: Remove product tubes [vial] from the package. Separate one tube from the others. 

Holding the tube [vial] with notched end pointing up and away from the face and body, cut off 

the narrow end at the notches with scissors. 

How to apply: Invert tube over dog and use open end to part dog's hair. Squeeze tube firmly to 

apply all of the solution to the dog's skin, as directed below. Repeat application may be made if 

necessary, but do not apply more often than once every 4 weeks. 

FREQUENCY OF APPLICATION 

Use [brand name ] monthly for complete control of flea, tick [and] chewing lice [and to kill 

mosquitoes] [infestations]. [Studies show that] [brand name] kills fleas (in as little as 1 hour) for 

up to three months. If your pet is at high risk for flea reinfestation [, or in a highly infested 

environment], apply monthly. Apply monthly to control ticks, mosquitoes and chewing lice. 

[Brand name] kills mosquitoes within 24 hours for the first 7 days after treatment, then within 48 

hours for up to 28 days. [Brand name] remains effective, even after bathing, water immersion, or 

exposure to sunlight. Allow treated area to dry thoroughly. Do not reapply for 30 days. 

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EPA Reg. No. 2517-XX 

.•... .•.•. ... .. ..... .. . ... .. ·.DOG SQUEEZE ON 

FIPRONIL+CYPHEN01;'HRIN+METH(JPRENE 

For Dogs Weighing up to 22 Ibs. 

{For cartons containing .67 ml (0.023 fl. oz.) applicator tubes} 

Apply one tube (.67ml)(0.023 fl. oz.) [as a spot to the dog's back between the shoulder blades) 

[from the back of the neck to a point midway between the neck and tail1. 

For Dogs Weighing Between 23-44 Ibs. 

{For cartons containing 1.34 ml (0.045 fl. oz.) applicator tube} 

[Apply two tubes (.67 ml)(0.023 fl. oz.) as a spot on the dog's back between the shoulder blades) 

[or] [Apply one tube (1.34 ml)(0.045 fl. oz.) as a spot to the dog's back between the shoulder 

blades.) [from the back of the neck to a point midway between the neck and tail]. 

For Dogs Weighing Between 45-88Ibs. 

For cartons containing 2.68 ml (0.091 fl. oz.) applicator tube} 

Apply one tube (2.68 ml)(0.091 fl. oz.) [as a spot on the dog's back between the shoulder blades) 

[from the back of the neck to a point midway between the neck and tail). 

For Dogs Weighing 89-132 Ibs. 

For cartons containing 4.02 ml (0.136 fl. oz.) applicator tube} 

Apply one tube (4.02 ml)(0.136 fl. oz.) [as a spot on the dog's back between the shoulder blades) 

[from the back of the neck to a point midway between the neck and tail]. 

STORAGE AND DISPOSAL 

PESTICIDE STORAGE: Do not remove tube from the pack until ready to use. Store in a cool [below 

nOF (25"C)] dry place inaccessible to children and pets. Do not refrigerate. Protect from direct sunlight. 

PESTICIDE DISPOSAL AND CONTAINER HANDLING: Non-refillable container. Do not reuse or 

refill this container. If empty: Place in trash or offer for recycling if available. If partly filled: Call your 

local solid waste agency for disposal instructions. Never place unused product down any indoor or 

outdoor drain. 

[WARRANTY 

Read the entire Directions for Use and Warranty before using this Product. By using this product, user or 

buyer accepts the following warranty. [[111e directions for use of this product are believed to adequate 

and must be followed carefully. It is impossible to eliminate all risks associated with the use of this 

product. Unintended consequences may result because of unknown factors. All such risks shall be 

assumed by the user or buyer.]] Sergeant's is committed to providing high quality products. To the 

extent consistent with applicable law, Sergeant's makes no warranties, express or implied, of 

merchantability or of fitness for a particular purpose or otherwise, that extend beyond statements on this 

label. To the extent consistent with applicable law, Sergeant's, the manufacturer, or the Seller shall not 

be liable for indirect, special, incidental or consequential damages. To the extent consistent with 

applicable law, the exclusive remedy of the user or buyer shall not exceed the purchase price paid.] 

[If you have questions or comments about this product, please write: Sergeant's Consumer Response, 

p.o. Box 540399, Omaha, NE 68154-0399.] 

In Case of Emergency, call: 1-800-781-4738 [For more information] [Visit us at] [www.sergeants.com] 

Non-Emergency call 1-800-224-PETS (7387) [Made in USA] 

115
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Version 10.1 

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EPA Reg. No. 2517-XX 

Sergeant's Pet Care Products, Inc. 

P.O. Box 540399 

[BAR CODE AREA] 

Omaha, NE 68154-0399 

EPA Reg. No. 2517-XX 

EPA Est. No. XXXXX-XX-XXX 

[Optional Insert or package copy] 

[How to Apply - May contain graphics illustrating product use, e.g., dog with a drop 

falliug onto its neck from a vial on front, side, or back carton label and/or applicator 

labeling.) 

[{ Outer Packaging or Insert Copy}] 

How to open 

1. Remove product tubes [vial} from the package. 

2. Separate one tube from the others. Holding the tube [vial} with notched end pointing up 

and away from the face and body, cut off the narrow end at the notches with scissors. 

How to apply: 

1. Invert tube over dog and use open end to part dog's hair. 

2. Squeeze tube firmly to apply all of the solution to the dog's skin [as a spot to the dog's 

back between the shoulder blades.] [or] [from the back of the neck to a point midway 

between the neck and tail.] 

[Flea life cycle diagram) 

[Look at the Label (Look at the Label icon) [Easy] 6 Step [Spot On] [Squeeze-On] [Topical] 

Checklist 

• Read the label completely and follow directions 

• Weigh your pet 

• Do NOT use Dog products on Cats 

• Do NOT treat with more than one pesticide product at a time 

• Separate animals after treatment to avoid chance of ingestion 

• Do NOT split tubes between pets] 

[Brand Name) 

[Monthly reminder card] 

[Apply [Brand Name] monthly for continuous protection against Fleas (in as little as I hour), 

Ticks (in as little as I hour), [and] chewing lice [and mosquitoes].] 

[Pet's Name (Empty blank for owner to fill in name)] 

[First [dose] [Treatment] (Empty blank for owner to fill in date)] 

[Second [dose] [Treatment] (Empty blank for owner to fill in date)] 

[Third [dose] [Treatment] (Empty blank for owner to fill in date)] 

116
Jergeant's® Master La",d 

11 August 2010 Version 10.1 EPA Reg. No. 2517-XX 

Information in [ ] is optional. Page 8 of 8 

[calendar stickers with brand name] [Place stickers on your calendar as a reminder (0 reapply 

[brand name] [in 30 days.] 

[Monthly Application Reminder Magnet (image of reminder magnet) 

Enclosed for your convenience is an application reminder magnet. Push the (reset) button to 

start the clock. After 30 days the magnet will flash (and beep) reminding you to reapply [Brand 

Name]. This application reminder can be used for future treatments. Just press the reset button 

and in another 30 days the reminder magnet will flash (and beep) reminding you (0 reapply.] 

{END - OPTIONAL INSERT OR PACKAGE COPY} 

TlJ.I3E/WALLABEL 

Front Label 

{Brand Name) 

Fipronil 9.8%, Cyphenothrin 5.0%, (S)-

methoprene 8.8% 

0.67 mL (or) 1.34 mL (or) 2.68 mL (or) 4.02 

mL {label code) 

Back Label 

KEEP OUT OF REACH OF CHILDREN 

WARNING: Read directions and precautions 

before using. Use scissors to open. 

EPA REG. No. 2517-XX {label code) 

[Optional: Example pictograms that mayor may not be found on the printed label] 

117
Pet CarB 

2G25 South 158th Piaza * Omaha. tJE 68130~ '1770 a Tenon"""p 402,938,7000 9 Fax 402.938,7099 G www.sergeants,corn 

! 5. December 200tJ 

Richard Gcbkcn 

Product lVlanager 22 

Document Processing Desk 

Officc of Pesticide Programs 

U.S. Environmental Protection 

Room S-4900. One Potomac Yanl 

2777 South Crystal Drive 

Arlington. V A 22:?02-450 I 

Dear Mr. Gcbken: 

Sergeum's Pet Cnre Products. Inc. (Sergeant's. 2625 South lSg'h Plaza. Omaha. Nehraska 

log 130·1770. EPA Company Number 2SI7). authorizes Exponent. Inc. (1150 Connecticut 

Avenue, NW. Suite 1100. Washington DC. 2()O~6) to act on our behalf as our 

Authorized Representative. tClr all necessary interactions regarding all of our product 

registration applications and registrations. Please note this does not change the CU1Tcnt 

IilccI Authorized Agclll!t)l' Sergeant's. 

The Ex ponen!. Inc. e<1I1tact is as (,lIows: 

James Messina and/or Rick Tinsworth 

Exponent. Inc. 

1150 Connecticut Ave" NW 

Suite I JOO 

\Vashington, DC 20036 

(lOl) 772·4932 

(lOll 77]A979 til, 

j m essi II (1(// ex po n en t. comlrti ns W orth((lJeX ponen t. com 

If you hayc any questions, 

Kelly R. 

fvlanager ofTechnicid Affllirs 

cc: James Messina 

118
Sergeant's Pet Care Products, Inc. 

2625 South 158th Plaza • Omaha, NE 68130-1770 • Telephone 402.938.7000 • Fax 402.938.7091 • www.sergeants.com 

August 11, 2010 

Richard Gebken, PMI 0 

Office of Pesticide Programs (7504P) (REGFEE) 

U.S. Environmental Protection Agency 

Document Processing Desk 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

Subject: Submission of EPA Pesticide Registration Improvement Act Information 

Dear Mr. Gebken: 

Sergeant's Pet Care Products, Inc. (Sergeant's, 2625 South 158th Plaza, Omaha, NE 68130-1770, 

EPA Company Number 2517), is submitting Pesticide Registration Improvement Act 

Information for the following new registration application: 

• Sergeant's Fipronil + Cyphenothrin + Methoprene Squeeze-On for Dogs R31O, $4,578 

(50% fee waiver $2,289), Pay.gov Tracking ID: 251 OIM08, Agency Tracking ID: 

74122352649. 

This registration application is for a new end-use product with supporting data and is considered an 

R310, new end-use product, requires review of data package within RD, PRIA review time frame 6 

months, and a fee of$4,578. Sergeant's qualifies for a PRIA fee waiver/reduction of50% (refer to 

OPP Decision Number D-425455). 

If you have any questions or need additional information regarding this registration application, 

please contact me at 402-938-7079. 

Sincerely, 

0A ~. tk'biuwS ) tA-l 

Kelly QHoskins 

Manager of Technical Affairs 

119
Voluntary Small Business Certification Form for 

Pesticide Registration Fee WaiverlReduction 

Section 1: Business Identification 

Company Name: Sergeant's Pet Care Products, Inc. 

Address: 2625 South 158m Plaza 

Omaha, NE 68130-1770 

EPA Company Number: 2517 

Contact Name: Kelly R. Hoskins 

Manager of Teclmical Affairs 

Phone Number: 402-938-7079 

Fax Number: 402-938-7091 

Email: KHoskins@SERGEANTS.com 

Section 2: EPA Pending Action Identification 

Product Name: Sergeant's Fipronil + Cyphenothrin + 

Methoprene Squeeze-On for Dogs 

Description of Action Submitted to EPA: New end-use product with efficacy data 

EPA Identification 25 I 7-NEW 

EPA Fee Category and Fee EPA PRIA fee category R31 0, 6 month 

review, $4,578 (50% fee waiver $2,289) 

Section 3: Small Business Information/Documentation 

Fee Waiver Support as a Small Business (as Yes, 50%. 

applicable): 

Is the Applicant a business entity with one or No. Refer to previously filed request ofDmore affiliates? 425455 (May 4, 2010) 

Business structure: include a chart or statement Refer to previously filed request ofDdescribing the applicant's business entity, its 425455 (May 4,2010) 

relationships to parent/owner company(s) and/or 

affiliate company( s), and the percentage interest 

of each owner/affiliate. 

Including parent and affiliate(s), the applicant's ( ) $10 million/year (75% fee waiver) 

average annual global gross revenue from ( x ) $60 million/year (50% fee waiver) 

pesticides for the last 3 years was less than or 

equal to: 

Documentation: Inel ude revenue statements for Refer to previously filed request ofDthe Applicant showing annual global gross 425455 (May 4, 20 I 0) 

revenue from pesticides for each of the three 

most recent completed fiscal or tax years. 

Applicant's ( ) fiscal year (x) tax year ends on: September 30 

Applicant's Audited Financial Statements are January 31 

available on/about: 

Does the Applicant now employ 500 or fewer Yes 

employees? 

Documentation: include the most recent IRS 941 Refer to previously filed request ofDor W3 or other official documentation 425455 (May 4, 20 I 0) 

120
Section 4: Certification Statement 

I, Joe Connealy, the Vice President of Finance (title), of the above-named Applicant, am 

authorized and have personal knowledge sufficient to make this certification on behalf of this 

Applicant. I hereby certify under penalty of peIjury that the information in Sections 1-3 above 

and the documentation submitted and/or relied on in connection with this Applicant's Fee 

Waiver/Reduction request are true, complete, and correct in all material respects, and accurately 

represent the current business status of this Applicant. 

~-s;;; Cvllttu1lUt1 

Joe Connealy I ~ 11- 2010 

Date 

121

Section 4: Certification Statement 

I, Joe Connealy, the Vice President of Finance (title), of the above-named Applicant, am 

authorized and have personal knowledge sufficient to make this certification on behalf of this 

Applicant. I hereby certify under penalty of peIjury that the information in Sections 1-3 above 

and the documentation submitted and/or relied on in connection with this Applicant's Fee 

Waiver/Reduction request are true, complete, and correct in all material respects, and accurately 

represent the current business status of this Applicant. 

~-s;;; Cvll1t4 /Ut1 

Joe Connealy I 08 -11- 2010 

Date 
122

*Confidential Statement of Formula may be entitled to confidential treatment*
123

*Confidential Statement of Formula may be entitled to confidential treatment*
124

*Confidential Statement of Formula may be entitled to confidential treatment*