BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE- benzoyl peroxide soap 
Only Yourx, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Directions: use 1 to 3 times daily for oily skin and scalp; apply with fingertips, using circular motion; gently scrub into a lather; rinse off thoroughly with warm water; if going outside, use a sunscreen

Warnings: For External Use Only

Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Disodium Cocoamyphodiacetate, Glycerin, Ethoxydiglycol, Cocoamidopropyl Betaine, Acrylates C10-20 Alkyl Acrylates Crosspolymer, Disodium EDA, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Polyacrylmide, C13-14 Isoparaffin, Laureth-7, Ethylhexylglycerin, Phenoxyethanol

Uses: treats acne and helps prevent new acne blemishes from forming; kills acne bacteria

Treats acne and prevents new acne blemishes from forming

Active Ingredients: Benzoyl Peroxide 2.5%

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Consult a doctor: if excessive irritation occurs

Other Information: store at room temperature; keep tightly closed

Benzoyl Acne Wash -2.5%

BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE 
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70367-009-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
2NDC:70367-009-08240 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
3NDC:70367-009-7522.2 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/26/2014
Labeler - Only Yourx, Inc. (089207519)

Revised: 1/2020
Document Id: 9cd5703c-a84e-955b-e053-2995a90a87af
Set id: 77468c7b-1906-c4fa-e053-2991aa0a8f06
Version: 2
Effective Time: 20200123
 
Only Yourx, Inc.