Label: BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE- benzoyl peroxide soap
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Contains inactivated NDC Code(s)
NDC Code(s): 70367-009-04, 70367-009-08, 70367-009-75 - Packager: Only Yourx, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 23, 2020
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- DOSAGE & ADMINISTRATION
- WARNINGS
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INACTIVE INGREDIENT
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
- INDICATIONS & USAGE
- PURPOSE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE
benzoyl peroxide soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70367-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70367-009-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 2 NDC:70367-009-08 240 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 3 NDC:70367-009-75 22.2 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/26/2014 Labeler - Only Yourx, Inc. (089207519)