Label: ACNE TREATMENT SYSTEM- benzoyl peroxide, salicylic acid kit
- NDC Code(s): 67226-1021-1, 67226-2050-3, 67226-3026-9
- Packager: Vivier Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2023
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INGREDIENTS AND APPEARANCE
ACNE TREATMENT SYSTEM
benzoyl peroxide, salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-3026 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-3026-9 1 in 1 KIT 11/11/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 30 mL Part 2 1 BOTTLE, PUMP 150 mL Part 1 of 2 ACNE TREATMENT
benzoyl peroxide lotionProduct Information Item Code (Source) NDC:67226-2050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LANOLIN OIL (UNII: OVV5IIJ58F) LAURETH-4 (UNII: 6HQ855798J) LAURETH-7 (UNII: Z95S6G8201) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2050-3 1 in 1 BOX 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 11/01/2011 Part 2 of 2 MEDICATED WASH
salicylic acid liquidProduct Information Item Code (Source) NDC:67226-1021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A) DMDM HYDANTOIN (UNII: BYR0546TOW) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-1021-1 150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 11/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 11/11/2017 Labeler - Vivier Pharma, Inc. (250996550) Establishment Name Address ID/FEI Business Operations Dermolab Pharma Ltd 245414743 manufacture(67226-3026, 67226-2050, 67226-1021)