133 UNITED . ATES ENVIRONMENTAL PROTECTION /, JNCY FEB 2 8 2012 Ms. Mary C. Pisculli Reckitt Benckiser, Inc. Morris Corporate Center IV 399 Interpace Parkway Parsippany, NJ 07054-0225 SUBJECT: Lysol Brand Disinfectant Direct Multi-Purpose Cleaner EPA Registration Number: 777-66 Application Date: December 2, 2011 Receipt Date: December 5, 2011 Dear Ms. Pisculli: The following amendment, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, is acceptable subject to the conditions listed below: • Label Update Conditions Revise the label as follows: 1) Correct the first page of the label to indicate that this is page 1 of 30 total pages. 2) Please note that the in the fourth statement of the packaging claims section on page 2 the terms "Great" and "Super" may not be used alone as each would imply heightened efficacy. "Great" and "Super" may only be used in conjunction with the terms "Value," "Pack," "Refill," and "Size". 3) The following sections on page 9 must be relocated to the directions for use section of the label: Terminal Sterilant Statement-qualified metal surfaces, Terminal Sterilant Statement-unqualified metal surfaces, and the HIV directions for use. Each of these sections contains directions for use and thus must pg placet eOMCUMMNCU SYMBOL I y$ldf SURNAME k DATE } ahgfa EFK Form 1320-1A (1/90) Printed on Recycled Paper UNITED ..ATES ENVIRONMENTAL PROTECTION * .cNCY 4) Make the following clarifications to page 7 in the sanitizing claims and supporting sanitizing claims sections. Revise to state: "Kills 99.9% of Staphylococcus aureus on hard, non-porous, non-food contact surfaces (in 30 seconds)" , "Kills (Destroys) (Eliminates) 99.9% of household bacteria (commonly found in kitchens) (on hard, non-porous, non-food contact surfaces) in 30 seconds.***" , "Sanitizes (kitchen) (household) (bathroom) (restroom) (washroom) non-food contact surfaces in 30 seconds***" and "Kills 99.9% of (Escherichia coli (Streptococcus pyogenes) on hard non- porous non-food contact surfaces (in 30 seconds.)" 5) Delete the following two statements on page 8. Each either indicates that this product will disinfect, sanitize or kill germs while it cleans. This is incorrect as the disinfection or sanitization directions must be followed to eliminate antimicrobial pests. Thus delete the statements: "Disinfects (Deodorizes) (and Sanitizes) as it Cleans" and "Kills germs while it cleans." These are the 6th and 22nd statements. 6) Revise the contact time in the HIV section on page 9 to be in agreement with the last stamped label for this product by correcting to read "remain wet for 10. minutes.'" 7) Revise page 26 to include product use surfaces and sites (as per page 18) in the directions for use section. 8) Relocate and place in bold text the statement found on page 26: "Do not use on eating/cooking utensils, glasses/dishes or cookware." Such that this statement immediately precedes the directions "To Clean/Deodorize". Should you wish to retain a reference to the company's website on your label, then please be aware that such a reference transforms the website into labeling under the Federal Insecticide Fungicide and Rodenticide Act sec 2 (p) (2) and then the website is subject to review by the Agency. If the website content is false or misleading, the product would be misbranded and its sale or distribution unlawful to sell or distribute under FIFRA section 12(a)(l)(E). 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. Although EPA has not yet determined the extent to which it will routinely review company websites, if the Agency finds or if it is brought to our attention that a website contains false or misleading statements or claims substantially differing from claims approved through the registration process, the website may be referred to the EPA's Office of Enforcement and Compliance Assurance. COHCURftEHCCS SYMBOL ^ SURNAME } DATE ) OFFICIAL FILE COPY EF* Fwtn 1320-1A (1/90) Printed on Recycled Paper UNITED . ATES ENVIRONMENTAL PROTECTION The stamped accepted label has been made part of the record for your file. General Comments A stamped copy of the accepted labeling is enclosed. Submit one (1) copy of your final printed labeling before distributing or selling the product bearing the revised labeling. Should you have any questions concerning this letter, please contact Tracy Lantz at (703) 308-6415. Sincerely, Velma Noble Product Manager (31) Regulatory Management Branch I Antimicrobials Division (751 OP) Enclosure: Stamped accepted label 7510P:T.Lantz:2/22/12:777-66 b accepted label amend COHCURKENC 5 SYMBOL k SURNAME } DATE } OFFICIAL FILE COPY EWV Form 1320-1A (1/90) Printed on Recycled Paper Lysol Brand Disinfectant Direct Multi-Purpose Cleaner Amended: 12-02-2011 EPA Reg. No.: 777-66 Page No.: 1 i 3o « FRONT PANEL » ACTIVE INGREDIENT: Alkyl (67% Ci2, 25% Cu, 7% Ci6, 1% C8-Ci0-Ci8) dimethyl benzyl ammonium chloride. 0.0860% Alkyl (50% CM, 40% Ci2, 10% Ci6) dimethyl benzyl ammonium chloride 0.0216% OTHER INGREDIENTS: 99.8924% TOTAL: 100.0000% KEEP OUT OF REACH OF CHILDREN WARNING: See (back) (side) panel for additional precautionary statements. ACCEPTBDr CONTENTS:]S:} 2 FL. OZ. 59 mL 35 FL. OZ. (1 QT. 3FL. OZ.) 1.03L with COMMENTS 1£ 9FL. OZ. 500 mL 36 FL. OZ. (1 QT. 4FL. OZ.) 1.06L in EPA Letter Doted: 17 FL. OZ. (1 PT. 1 FL. OZ.) 502 mL 40 FL. OZ. (1 QT. 8FL. OZ.) 1.18L 22 FL.OZ. (1 PT. 6FL. OZ.) 650 mL 4?,2 FL. OZ. (1.32 QTS. 1 1.25L FEB 2 8 2012] 24 FL. OZ. (1 PT. 8FL. OZ.) 709 mL 60 FL. OZ. (1 QT. 28 FL .OZ.) 1.77L inder the Federal Insecticide, 25 FL. OZ. (1 PT. 9FL. OZ.) 739 mL 64 FL. OZ. (2 QTS.) 1.89L ungiade, and Kodentiade Act as 26 FL.OZ. (1 PT. 10 FL .OZ.) 768 mL 96 FL. OZ. (3 QTS.) 2.84 L mended, tor tte pesticide, 28 FL. OZ. (1 PT. 12 FL .OZ.) 828 mL 128 FL. OZ. (1 GAL.) 3.78L sgistered under EPAHeg. No. 77 FL. OZ. (1 QT. ) 946 mL 144 FL. OZ. (1.125 GAL.;I 4.25L '-**32 « FRONT / BACK PANEL » EPA Reg. No 777-66 EPA Est. No.: 777-NJ-2 8791-MO-1 (See bottom or side) (for Lot / Date code) « BACK PANEL » Questions? (() (Call:) (1-800-228-4722) (1-800-677-9218) For ingredient (and other) information, (www.rbnainfo.com) I Distributed by: Reckitt Benckiser, Parsippany, NJ 07054 (-xxxx) Made in U.S.A. © (year) RB Contains no phosphates. This (bottle) (container) is made of 23% post-consumer recycled plastic. Reckitt Company graphic logo Benckiser « FRONT/ BACK PANEL - Option text » Kosher Certification Symbol NSF Certification Symbol: Important facts (about this product) Encourage your state and local authorities to establish a program to recycle this (bottle) (container). | IMPORTANT: For directions for use and first aid instructions in Spanish, please call 1-877-843-3817. , | « Spanish Translation » jj_ | IMPORTANTE: Para instrucciones de uso y primeros auxilios en espanol por favor llamfe al 1-877-84?.-38 j j 1 Tj. | i . ij ) j j j j Learn more about (the importance of good hygiene habits) (and the many ways that Lysol® is oroiwing good hygiene habits) (for your family and community), go to www.spreadinghealth.com. NOTE: Bracketed information is denoted as: « directive », {insert as noted }, ( optional text), [ requ'r'K'qualifier]. The term "this product" used throughout this document may be replaced with the marketed product brand nam To use the term "germ**" the product must be efficacious against 2 of the 3 major classes of organisms. The product label must identify the specific bacteria, virus, fungus & mold. > i The term 'x' is a place holder for a number between 1 to 99 j Lysol Brand Disinfectant Direct Mult, jrpose Cleaner Amended: 12-02-2011 EPA Reg. No.: 777-66 Page No.: 2 of 22 « NOTE: Any claim may appear on FRONT / BACK panel in bullet / paragraph format - Unless otherwise noted._>> « INTRODUCTORY 6-mos. CLAIMS - will only appear on graphic label for the first 6 months product is on shelf » (Complete) (New) (Improved) (Formula) « FRAGRANCE CLAIMS » (Citrus) (Country) (Crisp Berry) (Floral) (Forest Rain) (Fresh) (Fresh Mountain) (Garden) (Green Apple) (Lemon) (Orange) (Pacific Fresh) (Springtime) (Summer) (Summer Fresh) (Breeze) (Scent) (Unfragranced) (Unscented) (Mild) (Clean) (Pleasant) (Long Lasting) (Fragrance) (Fresh Fragrance) « PACKAGING CLAIMS » (Bonus) (Bonus x%) (Bonus x 02.) (x% Discount) (x% More Free) (x oz. at x oz. Price) (x oz. for the x oz. price) (x oz. at the price of x oz.) (x oz. for the price of x oz.) (More than) (over) (x # of sprays per bottle) (x # of squirts per bottle) (x # of uses per bottle) (Economical) (Economy) (Great) (Mega) (Super) (Trial) (Value) (Pack) (Refill) (Size) « MARKETING CLAIMS » (3-in-1) (4-in-1) (All Purpose Cleaner) (Antibacterial) (Express) (Clean & Fresh) (Multi-Action) (Multi-Purpose) (Multi-Surface) (Triple Action) (Versatile) (Bathroom) (Floor) (Glass & Surface) (Kitchen) (Restroom) (Cleaner) (Cleaning) (Disinfectant) (Sanitizer) (Contains:) (Made with:) (Natural Pure Orange Oil) (Pure Orange Oil) (Orange Oil) (Antibacterial) (Antibacterial Action) (Bactericidal*) (Bactericide*) (Deodorizer) (Deodorizes) (Disinfectant) (Disinfects) (Fungistat) (Fungistatic) (Germicidal**) (Virucidalt) A clean you can smell America's Home Disinfectant Combines streak-free cleaning with antibacterial action Contains no (abrasives) (bleach) Contains powerful grease cutters Convenient (bathroom) (restroom) (kitchen) (floor) (surface) (cleaner) Easy to use