UNITED STATES ENVIRONMENTAL PROTECTION AGENCY …
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
June 7, 2019
Amanda Landolt Reckitt Benckiser LLC Morris Corporation Center IV 399 Interpace Parkway Parsippany, NJ 07054-0225
Subject:
PRIA Label Amendment ? Add Additional Microorganisms, Marketing Claims, and Additional Brand Names. Product Name: Brace EPA Registration Number: 777-99 Application Date: Nov. 14, 2018 Decision Number: 546260
Dear Ms. Landolt:
The amended label referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide and Rodenticide Act, as amended, is acceptable. This approval does not affect any conditions that were previously imposed on this registration. You continue to be subject to existing conditions on your registration and any deadlines connected with them.
A stamped copy of your labeling is enclosed for your records. This labeling supersedes all previously accepted labeling. You must submit one copy of the final printed labeling before you release the product for shipment with the new labeling. In accordance with 40 CFR 152.130(c), you may distribute or sell this product under the previously approved labeling for 18 months from the date of this letter. After 18 months, you may only distribute or sell this product if it bears this new revised labeling or subsequently approved labeling. "To distribute or sell" is defined under FIFRA section 2(gg) and its implementing regulation at 40 CFR 152.3.
Should you wish to add/retain a reference to the company's website on your label, then please be aware that the website becomes labeling under the Federal Insecticide Fungicide and Rodenticide Act and is subject to review by the Agency. If the website is false or misleading, the product would be misbranded and unlawful to sell or distribute under FIFRA section 12(a)(1)(E). 40 CFR 156.10(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 will be referred to the EPA's Office of Enforcement and Compliance.
PRIA Label Amendment Acceptable v.20150320
Page 2 of 2 EPA Reg. No. 777-99 Decision No. 546260
Your release for shipment of the product constitutes acceptance of these conditions. If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6.
The following 18 Alternate Brand Names have been added to the product record.
Disinfectant Spray Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Crisp Linen Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Spring Waterfall Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Green Apple Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Summer Breeze Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Original Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Country Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Crisp Berry Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Garden Mist Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Citrus Meadows Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Early Morning Breeze Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Vanilla & Blossoms Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Jasmine & Rain Scent Lysol Brand Kills 99.9% of Viruses & Bacteria**
Disinfectant Spray Cherry Blossom & Pomegranate Scent Lysol Brand Kills 99.9% of Viruses & Bacteria**
Disinfectant Spray Crisp Mountain Air Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Lemon Breeze Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Adirondack Cool Air Scent Lysol Brand Kills 99.9% of Viruses & Bacteria** Disinfectant Spray Crystal Waters Scent Lysol Brand Kills 99.9% of Viruses & Bacteria**
If you have any questions, please contact Srinivas Gowda by phone at (703) 308-6354 or via email at gowda.srinivas@
Sincerely,
Jacqueline Hardy Product Manager 34 Regulatory Management Branch II Antimicrobials Division
Enclosure: EPA Stamped Label
BRACE EPA Reg. No.: 777-99
>
Amendment: November 13, 2018 (version 3) Page 1 of 28
ACTIVE INGREDIENTS: Alkyl (50% C14, 40% C12, 10% C16) dimethyl benzyl ammonium saccharinate . . . . . 0.10 % Ethanol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58.00 %
OTHER INGREDIENTS:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41.90 % TOTAL:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100.00 %
KEEP OUT OF REACH OF CHILDREN CAUTION: See (back) (side) panel for additional precautionary statements.
NET WT.:
X OZ.
(X g)
Eg. 1.0 OZ. (28 g)
Eg. 18 OZ. (1 LB. 2 OZ.) (510 g)
X x X OZ. (X LB. X OZ.) X g TOTAL WT.: X OZ.
(X LBS. X OZ.) X kg
Eg. 2 x 12.5 OZ. 354 g TOTAL WT.: 25 OZ. (1 LB. 9 OZ.) 708 g
Eg. 3 x 19 OZ. (1 LB. 3 OZ.) 538 g TOTAL WT.:57 OZ. (3 LBS. 9 OZ.) 1.6 kg
>
EPA Reg. No.: EPA Est. No.:
777-99 777-NJ-2 (Y) (YY) 11525-IL-1 (Y) (YY) 13891-IN-1 (Y) (YY) 69209-MA-001 (Y) (YY)
61203-MA-1 (Y) (YY) 33590-MA-3 (Y) (YY) 475-MO-1 (Y) (YY) 777-PA-001 (Y) (YY)
54487-GA-1 (Y) (YY) 498-IL-1 (Y) (YY) 11525-RI-1 (Y) (YY) 58996-MO-1 (Y) (YY)
777-MO-002 (Y)(YY) See (bottom) (or) (side) (cap) (for Lot / Date code) (Beginning of) (batch) (lot) code indicates EPA (Est.) (Establishment) (#) (No.) (Number) See (batch) (lot) code for EPA (Est.) (Establishment) (#) (No.) (Number) (Federal regulations prohibit CFC propellants in aerosols.) (Contains No CFC's or other ozone depleting substances (graphic symbol))
>
6/07/2019
Questions? (telephone graphic symbol)
(Call:) (1-800-228-4722) (1-800-677-9218) (1-xxx-xxx-xxxx)
(For more ingredient (and other) information visit () (website))
(US Patents: patents) Distributed by: Reckitt Benckiser, Parsippany, NJ 07054(-xxxx)
777-99
(Made in {insert country})
? RB {insert year}
IMPORTANT: For directions for use and first aid instructions in Spanish, please call 1-877-843-3817.
Steel Recycle (graphic symbol)
Please recycle when empty
Company Logo (Reckitt Benckiser) (rb) (Reckitt Benckiser Professional) This can is made from an average of 25% recycled steel [10% post-consumer].
> Peel open for Precautionary and First Aid Statements. See outer packaging for Directions for Use and additional Precautionary Statements. Important facts (about this product): Encourage your local authorities to establish a program to recycle this can. Learn more about (the importance of good hygiene habits) (and the many ways that Lysol? is promoting good hygiene habits) (for your family and community).
NSF Certification Symbol For Hospital Use (graphic ? may only appear on Professional Branded product labels)
NOTE:
Bracketed information is denoted as: >, { insert as noted }, ( optional text ), [ required qualifier ]. The term "this product" used throughout this document may be replaced with the marketed product brand name. 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. The term "x" is a place holder for a number between 0 to 104. The term "Y" is a place holder for a character A ? Z.
BRACE EPA Reg. No.: 777-99
Amendment: November 13, 2018 (version 3) Page 2 of 28
>
>
Example
(Use your phone to) (and) (or) (scan) (the) (tag) (or) (this code) (to learn) (or) (to) (see) (more) (uses) (or) (information) (videos) (on how to use) (this product) (for) (how to) (tips)
>
> Fresh(er), (cleaner) fragrance Great (New) Scent New Formula New (and Improved) (better) Fragrance New (and)(&) (Improved) (Look)(Design) (New) (and) (improved6) (ergonomic design) (cap) (!) New Clean, Fresh Fragrance New (Fragrance) (Scent) ({insert fragrance name}) New (now) (Surprisingly) Fresh Fragrances Now with (a) fresher fragrance(s) (Smells) (better) than ever ({insert fragrance / name})
> New (easy to) (spray) (use) cap (pack) New look (for) (Lysol?) New Size New spray nozzle
New (Modern) (design) (packaging)
Now in (an) (a) attractive pack Now even easier to spray(!)6
>
Alpine Apple (P) Aqua Aromatherapy Baby Powder (Berry) (Bliss) Blossom Blue Reflection Breeze Calming Vanilla Cherry Citrus Citrus & Morning Citrus Meadows Clean Renewal Clean Vanilla (Cool) (Adirondack) (Air) Cool Essence Cool Vanilla Country Cranberry Crisp Berry Crisp Linen
Crisp Mountain Air Crystal Waters Crush Dew Driftwood Waters Early Morning Breeze Energy Fresh Fresh Oriental Spice Fresh Vanilla Fresh Vanilla Breeze Fresh Vanilla Spice Garden Garden Essence Garden Mist Ginger Ginseng
Hawaii Sunset Essence Herbal Citrus Hibiscus Hawaii Sunset Essence Hint of Vanilla Jasmine Jasmine Dream Jasmine & Rain Kitchen Key lime Lavender Lavender Fields Lemon Lemon Breeze Lily Lush Meadows Mandarin
Green Apple Green Apple Green Apple Breeze Green Tea Green Floral
Meadows & Vanilla Meadow Sunrise Morning (Morning) Linen Morning Meadow
Ocean Zest Orchard Blossom Original Oxygen Oxygen Breeze Oxy Sensation Peach Pear Peony Pomegranate Pumpkin (Pure) (Air) Pure Breeze Pure Rain Pure Sky Purity Rainfall
Refreshing Revitalizing Mist Rose Sheer Vanilla
Soft Powder Soothing Spice Soothing Warmth Spring Waterfall Strawberry Summer Breeze Sundrenched Linen Tropical Tropical Escape Unscented Vanilla Vanilla & Spring Vanilla Mist Vanilla Sky Wave White Lotus White Orchard
White Sails White Tea
(Scent)(Fragrance) (and) (&) (Sparkling) (after the)
NOTE:
Bracketed information is denoted as: >, { insert as noted }, ( optional text ), [ required qualifier ]. The term "this product" used throughout this document may be replaced with the marketed product brand name. 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. The term "x" is a place holder for a number between 0 to 104. The term "Y" is a place holder for a character A ? Z.
BRACE EPA Reg. No.: 777-99
Amendment: November 13, 2018 (version 3) Page 3 of 28
(Crisp) (Crystal) (Rose) (Hint of) (Hint off) (Cascading) (Medley) (Island) (Holiday) (Rustic) (Fusion) (Festive) (picked) (Floral) (Herbal) (Rain) (sun kissed) (Summer) (Spring) (Morning) (Ocean) (Bay) (Whisper) (Tropical) (Wild flower) ((Fruit)(s)(y)) (Valley) (No) (Fragrance) (Free) (Bouquet) (Splash) ((Scent)(ed)) (Great) (Invigorating) (Sheer) (Zest) (Essence) (mist) (Lush) (Splash) (Light) (Bloom) (Clean) (Spice) (Fields) (Burst) (Blue) (Blend) (Escape) (Power) (Gentle) (Serene) (Shower) (Petal) (Sweet) (Rolling) (French) (English) (Provence) (Valley) (Meadow) (Farm) (Hills) (Modern) (Smell) (Cucumber) (Basil) (and)(&) (Red fruit(s)) (Mango) (Freshcut) (Herbs) (Sea Salt) (Minerals) (Aloe) (Blast) (Infusion) (Wild) (Berries)
Available in {insert fragrance claims}
> 3 pack (!) 4 pack (!) x pack (!)
Bonus (size) (pack) Buy X Get X Free Dual Pack Mega (value) (pack) (size)
Mini (More) than 50% Free Pocket (size) (pack) Portable Purse (size) (pack)
Travel (size) (pack) Trial (size) (pack) Twin Pack Value (size)(pack) Extra (Value)(Pack)
X oz. for the price of X oz. X for the price of X X% (Free) (Bonus) (More) X% (cheaper) (less expensive) (off) X (%) (more) (value) (affordable)6 Better (value)6 Disinfection (Value) Pack Designed to Leave Out on the Counter Lower (cost) (per oz.) 6 Money saving (Can) (Pack) (Value) More (of the same) (great) (product) (Spray) (for less) 6 (Same) (great) (Lysol) (Spray) (at a better value) 6 Save (more) Save (money) (plastic) (with this product) Scratch (and) (&) (`N) Sniff (Scratch Me) (Scratch Here) (Take) (Carry) (it) (this product) (anywhere) (everywhere) (Try) (Try Me) (Try Me Out)
> Like (insert Lysol? brand name) (trigger) (cleaner)? Try (our) (insert Lysol? brand name) (insert picture of Lysol? Disinfecting Wipes) Like this fragrance? Try (our) other Lysol? products (insert picture of Lysol? product) Like this product? Try (our) other Lysol? products (insert picture of Lysol? product) Try (our) other Lysol? cleaning products (insert picture of Lysol? product) Try (our) other Lysol? fragrances (insert picture of Lysol? product) Try (our) (other) Lysol? family of (cleaning)(disinfecting)(sanitizing) products (insert picture of Lysol? product)
>
Antibacterial Antibacterial Action Antibacterial Spray Antimicrobial Bactericidal Bactericide Disinfectant (Spray) Disinfecting
Disinfecting Action Disinfecting Formula Disinfection Disinfects Fungicidal Fungicide Fungistat Germicidal
Germicide Mildewcide Mildewcidal Sanitizer (Sanitizes) Tuberculocidal Tuberculocide Virucidal Virucide
Virucidal Action Daily Multi-Action Multi-Purpose Multi-Room Multi-Surface Hard non-porous surface Soft Surface(s)
(X) minute contact time (X) second(s) contact time (Complete) (Disposable) (Easy to use) (Effective) (Everyday) (Everyday use) (Great) (Household) (Spray) (Lysol? Brand)
NOTE:
Bracketed information is denoted as: >, { insert as noted }, ( optional text ), [ required qualifier ]. The term "this product" used throughout this document may be replaced with the marketed product brand name. 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. The term "x" is a place holder for a number between 0 to 104. The term "Y" is a place holder for a character A ? Z.
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