UNITED STATES ENVTRONMENT AL PROTECTION AGENCY W ASHTNGTON, D.C. 20460
OFFTCEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
Adam Swader Regulatory Compliance Specialist MAY 1 2009 Athea Laboratories, Inc. 6161 N. 64th Street Milwaukee, WI 53218
SUBJECT: Application for Pesticide Notification per PR Notice 98-10 - Refonnatting Net Contents Insect Repellent Towel EPA Reg. No. 10088-97 Application Dated April 8, 2009
Dear Mr. Swader:
The Agency is in receipt of your Application for Pesticide Notification under Pesticide Registration Notice (PRN) 98-10 for the above product. The Registration Division (RD) has conducted a review of this request for its applicability under PRN 98-10 and finds that the action requested falls within the scope of PRN 98-10. The label submitted with the application has been date-stamped "Notification" and will be placed in our records.
If you have any questions, please call me directly at 703-305-6249 or Terri Stowe of my staff at 703-305-6117.
Sincerely,
Linda Arrington Notifications & Minor Fonnulations Team Leader Registration Division (7505P) Office of Pesticide Programs I~);l! 'Pi t m:.t;' , • jj , ;; ,. ..,?ilI ~ 'i {tr; ~i\~r,m];.;; " •• I'.~I '" •• " ; PI.... r ••d iMtfUt:tiOM on ,.".,.. btdo,. co form. Form ADDroved, OMB No. 207n.lV'lM A, eXDi, .. 2·28·: United States ~ Registration OPP Identifier Number Environmental Protection Agency Amendment &EPA , Washington, DC 20460 X Other Application for Pesticide - Section I 1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification 10088·97 o None D Restricted 4. Company/Product (Name) PM' Insect Repellent Towel 10
5. Neme end Address of Applicant (Include ZIP Code) 6. Expedited Reveiw. In accordance with FIFRA Section 3(c)(3) Athea Laboratories, Inc (b)(i), my product is similar or idotical in composition and labeling 6161 N. 64th St. to: N TIFICATION Milwaukee, WI 53218 EPA Reg. No. MAY o1 2009 D Check if this is 8 ne~ sddress Product Name Section - II
Amendment - Explain below. Final printed labels in repsonse to D D Agency letter dated D Resubmission in response to Agency letter dated D "Me Too" Application. G Notification - Explain below. U Other - Explein below. Explanation: Use additionel pege(s) if necessary. (For section I and Section 11.)
Net content declaration reformat notification per PR notice 98-1. (see attached page)
Section - III 1. Material Thi. Product Will Be Packaged In: Child-Resistant Packaging Unit Packaging Water Soluble Packeging 2. Type of Container Yes ~yes ~yes §M.~IX Plastic JGxt X No X No 5J Glass If "Yes" No. per If "Yes" No. per Paper • Certification must Unit Packaging wgt. container Package wgt container Other (Specify) be submitttKI I 3. Location of Net Contents Information 4. Size(s) Retail Container 5. Location of label Directions ~ On Label ~ Lebel o Conteiner On Labeling accor1)pani\1y Droduct c'o 0 0 6. Menner in Which Label is Affixed to Product §UthograPh Other Paper Pelued 0 :-;-:-:;- Stencied 0000" 000000 0 Section -IV 0 0 0 1. Contect Point' (Complete items directly below for identification of individual to ba contacted, ;t necessary: LOaer.986SS th£sQa/JpfifJation.) o ,!," Name Title ]TelePhone :;''ofo? Ylnclude Area Code) Adam Swader Regulatory Compliance Specialist o 0 ~ 0 '~14-354~604"17
Certification ,-,>..£'..!" ' I,o.:[;)ate Application o rO. ad I certify thet the statements I have made on this form and all attachments thereto are true, accurate and complete. f ecknowledge that any knowlinglly felse or misleading statement may be punishable by fine or imprisoMlent or ~ r: : ~:~~:amped) both undar applicable taw. ., 0 u v 3. Title 2S cfffl _. Regulatory Compliance Specialist 4. Typed N-;;;e Adam Swader S.D~h()'1
.. I ~PA Form 8570·1 IAltv. 3·941 PreVIous editions are obsolete. White • EPA FIle CODV lonalnll' Vellow ·ADDICMt Co ~ATHEA lABORATO~~IES, iNC.
April 8,2009
Document Processing Desk (NOTIF) Office of Pesticide Programs (7504C) U.S. Environmental Protection Agency 1200 Pennsylvania Ave. N.W. Washington, D.C. 20460
Dear Sir or Madam:
Re: Notification of label change Company: Athea Laboratories, Inc. Product: Insect Repellent Towel EPA Reg. Number 10088-97
We are submitting a notification for the reformatting of the net contents declaration to our EPA reg. #: 10088-97 Insect Repellent Towel label per PR notice 98-10.
"This notification is consistent with the provisions of PR Notice 98-10 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the confidential statement of formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this notification is not consistent with the terms of PR Notice 98-10 and 40 CFR 152.46, this product may be in violation ofFIFRA and I may be subject to enforcement action and penalties under section 12 and 14 of FIFRA."
The following documents are attached: EPA form 8570-1, 1 current label with changes highlighted, and 2 new labels.
Please contact me with any questions you may have 414-354-6417 or OGeo 0 0 [email protected] 0""00
0000 0 Sincerely, OOQO OOOOOQ 0 0 0 0 0 0 0 0 000000 000000 0 0 0 00 0000 0 00000 0000 0 0 ouooo 0
Regulatory Compliance Specialist 0000 0 Athea Laboratories, Inc. 0000 0 00 0 0 0 0000
P.O. Box 240014 1 Milwaukee, WI 53224 1 TEL 414.354.64171800.743.6417 1 FAX 414.354.9219 1www.athealaboratories.com
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Leaaers in High-Quality, Specialty-Chemical i?cr,oducts , <,' ~~;r' 'rl '.~h"' ,', q~~ ~. ':,~ " • "
PRECAUTIONARY STATEMENTS Words in italics are for reference only HAZARDS TO HUMANS AND DOMESTle ANIMALS ~ ~ INSECT Words in [ ] are alternate wording ~ = CAUTION Words in { } are optional wording KEEP OUT OF REACH OF INFANTS ~ ~REPELLENT AND YOUNGER CHILDREN u: eo Instruct older children in the proper use of this ~ ~ TOWEL product. Do not apply to lips or get into eyes. In • Repels Mosquitoes. Biting Flies. case of contact with eyes. flush with water. ;~".NO~..... Chiggers. Ticks. Deer Flies. Stable Towels apply repellent where you need it most. PHYSICAL OR CHEMICAL HAZARDS Flies. Black Flies. Gnats and Fleas Will not stain clothes or fabric. Do not use or store near heat or open flame. ~ ~ o ... on Exposed Skin Surfaces. Will not stain clothing or fabrics. DIRECTIONS FOR USE --t- ~ • Repels Most Biting Insects. Stain-free formula will not harm clothes. It is a violation of Federal law to use this product in a • S6n~ 0 • Repels Insects For HOllrs. Repellent formula will not stain clothes or fabrics. manner inconsistent with its labeling. • Made with aloe to keep skin smooth and soft. No excess spray with towels to harm decorative plants. Read and follow all directions and precautions on this • Formulated with aloe to keep skin smooth Easy-to-use towels apply repellent in one-step. product label. and soft. • Apply repellent in one easy step - tear off towel and wipe. {Open} {unfold} {towel[sJ}. Wipe or rub liberally on all ~Ith AI • Contains aloe to keep skin smooth and soft. • Portable canister goes anywhere. exposed skin areas: W oe. Made with aloe. a skin softening agent. Portable canister goes anywhere bugs are found. • Formulated with aloe. a skin softening agent. {Repeat when insects become annoying.} {For ticks Portable IS-count canister can be taken anywhere. and chiggers. also apply liberally to shoe tops. socks • Contains aloe. a skin softening agent. • Portable IS-count canister easily fits in pockets. and around openings of clothing.} {Repeat using a fresh ACTIVE INGREDIENTS: towel when necessary.} • Portable 40-count canister can be taken anywhere. DEET ...... 12.33% Portable 40-count canister easily fits in pockets. Do not allow children to handle this product. Do not apply N-Octyl bicydoheptene dicarboximide ...... 3.52% over cuts. wounds or irritated skin. Do not apply to eyes Di-n-propyl Isocinchomeronate ...... 1.76% Use towels at work or at play. and mouth and do not apply to the hands of young children. INERT INGREDIENTS: ...... 82.39% Soft. durable 12" x 12" towelette. Do not apply directly on face. Apply sparingly around ears. TOTAL...... 100.00% Non-greasy insect repellent. Use just enough repellent to cover exposed skin and/or • Portable. reseal able packaging. clothing. After returning indoors. wash treated skin with soap and water. Wash treated clothing. Use of this product . KEEP OUT OF REACH OF CHILDREN may cause skin reactions in rare cases. If you suspect that you or your child is reacting to this product. wash treated CAUTION skin and call your local poison control center. Have the FIRST AID: product container or label with you when calling a poison If Swallowed: Call a poison control center or doctor control center or doctor. or going for treatment. For immediately for treatment advice. Have person sip a emergency information. call the National Pesticide glass of water if able to swallow. Do not induce vomiting Information Center at 1-800-858-7378. unless told to do so by a poison control center or Avoid contact with plastics. such as eyeglass frames. and doctor. Do not give anything by mouth to an such fabrics as acetate rayon. unconscious person. If In Eyes: Hold eye open and rinse slowly and gently Manufactured By: STORAGE AND~DIS~OS~M. with water for 15-20 minutes. Remove contact lenses. if Do not contaminate water. fuu~ 05 <~ b~ ~
(may be bulleted, numbered, in sentence form; may also be used with pictorials):
Canister Directions:
I. Remove lid by lifting upward. 2. Pull towel from center of the roll t' ri', '- 5 dl and thread through "X" on the ~ \. -'4.c;.lg underside of the lid. ~.~. Z 3. Close lid. Pull towel at 90' angle. ' \ , g.~ 4. Snap hinged cap back into place to , 2~ ~~a ensure towels stay moist. !c ~ o ~ ou: -s; 1! {Resealable package instructions:} § ~, Peel back re-sealable label. Remove towel from the z: :is center of the pack. Reseal package to the closed position to keep towels moist.
t. ~"1~'-h, t----I'''. '~'~"l ~d.~~- .~~.~ ...~Pi Non-resealable packaging: Tear open envelope, remove towel.
- ..... '- '-' ... ATHEA LAB~AAtbR/ES.~/Nt~ 1540.020609 Product: Insect Repellent Towel Page 2 0(2 EPA #10088-97.
~ PRECAUTIONARY STATEMENTS Words in italics are for reference only HAZARDS TO HUMANS AND DOMESTIC ANIMALS INSECT REPELLENT Words in [ ] are alternate wording WARNING Words in { } are optional wording Causes substantial but temporary eye injury. Harmful TOWEL if swallowed. Do not get in eyes. Wash hands before • Repels Mosquitoes, Biting Flies, eating. drinking. chewing gum. using tobacco or using i/L..~?NO~ ..... Chiggers. Ticks, Deer Flies. Stable the toilet. Remove and wash clothing before reuse. . ()) Towels apply repellent where you need it most. ~ "'--< Flies, Black Flies, Gnats and Fleas o • on Exposed Skin Surfaces. Will not stain clothes or fabric. DIRECTIONS FOR USE "/; ~ • Repels Most Biting Insects. Will not stain clothing or fabrics. It is a violation of Federal law to use this product in a • Song 0 Stain-free formula wilf not harm clothes. manner inconsistent with its labeling. • Repels Insects For Hours. Repellent formula will not stain clothes or fabrics. Read and follow all directions and precautions on this • Made with aloe to keep skin smooth and soft. Easy-to-use towels apply repellent in one-step. product label. • Formulated with aloe to keep skin smooth and soft. Apply repellent in one easy step - tear off towel and wipe. Do not apply over cuts, wounds or irritated skin. Do not • Contains aloe to keep skin smooth and soft. Portable canister goes anywhere. apply near eyes and mouth. Apply sparingly around ears. • Made with aloe, a skin softening agent. Portable canister goes anywhere bugs are found. Do not apply to children's hands. Do not allow children to with~ Aloe • Formulated with aloe, a skin softening agent. Portable 18-count canister can be taken anywhere. handle this product. Do not apply more than 3 times per • Contains aloe, a skin softening agent. Portable 18-count canister easily fits in pockets. day to children ages twelve (12) and under. When using on children, apply to your own hands and then out it on the ACTIVE INGREDIENTS: Portable 40-count canister can be taken anywhere. child. Use just enough repellent to cover exposed skin andl DEET ...... 12.33% Portable 40-count canister easily fits in pockets. or clothing. Do not use under clothing. Avoid over N-Octyl bicycloheptene dicarboximide ...... 3.52% Use towels at work or at play. Di-n-propyl Isocinchomeronate ...... 1.76% application of this product. After returning indoors, wash Soft. durable 12" x 12" towelette. treated skin with soap and water. Wash treated clothing OTHER INGREDIENTS: ...... 82.39% Non-greasy insect repellent. before wearing it again. Use of this product may cause skin TOTAL ...... 100.00% z reactions in rare cases. If you suspect a reaction to this o gj Portable. resealable packaging. product. discontinue use, wash treated skin. and call your KEEP OUT OF REACH OF CHILDREN ;:; c::> C'-I local poison control center. If you go to a doctor, take this WARNING ~ ...... Contains (x)" x (x)" Premoistened product with you. FIRST AID: e (Towelettes) (Towels) (Wipes) If In Eyes: Hold eye open and rinse slowly and gently with g {Open} {unfold} {Towel[s]}. Wipe or rub sparingly on all water for 15-20 minutes. Remove contact lenses. if present. ... ~ exposed skin areas. {Repeat when insects become after the first 5 minutes, then continue rinsing eye. Call a poison o :::iE annoying.} {For ticks and chiggars, apply to shoe tops. socks control center or doctor for treatment advice. z ~""./ ./ ",.~':\ and around openings of clothing.} If Swallowed: Call a poison control center or doctor "- .".,t .R-,-;:.'7'Y ~~~jfjg immediately for treatment advice. Have person sip a glass of 'i~?:~~~t~~~. (clC':''l'Jii'.i·(ii1.. " Avoid contact with plastics, such as eyeglass frames, and water if able to swallow. Do not induce vomiting unless told to "'- ~ )~~1 ' such fabrics as acetate rayon. do so by a poison control center or doctor. Do not give .~r ~~' .;.- anything by mouth to an unconscious person.
STORAGE AND DISPOSAL If you suspect a reaction to this product: Discontinue Do not contaminate water, food, or feed by storage and use. Rinse skin immediately with plenty of water for 15- Manufactured By: disposal. ~ "'- 20 minutes. Call a poison control center or doctor for ATHEA LABORATORIES, INC. STORAGE: Do not store ....-hJ~~ chi;d:-en or~dI1imals may treatment advice. gain access. ~ :-: ~: ~ : P. O. Box 240014 IF EMPTY: Do not reuse this"contalner. l1ace in trash or Have the product container or label with you when calling a Milwaukee, WI 53224 offer for recycling if available. poison control center or doctor or going for treatment. You IF PARTLY FILL~D: ?dl YOU[ local cs
~ ~ DIRECTIONS FOR DISPENSING:
(may be bulleted, numbered, in sentence form; may also be used with piaorials):
Canister Directions:
I, Remove lid by lifting upward. 0 z 0 C7J» 2. Pull towel from center of the roll t' rI'-: «Q) and thread through "X" on the l ec- ~ ~ ~ underside of the lid. il'~' 0 3, Close lid. Pull towel at 90· angle. \ ~ 1ii:C> 4. Snap hinged cap back into place to, ~ ensure towels stay moist. I{:~ {Resealable package instructions:} Peel back re-sealable label. Remove towel from the center of the pack. Reseal package to the closed position to keep towels moist. ~~~ Non-resealable packaging: Tear open envelope, remove towel.
.... \., .... '- .... ATHEA LA&ORRJORlf5~ Itv.C. 1540.020609 Product: Insect Repellent Towel Page 20(2 fPA #10088-97
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