Label: ADAPALENE AND BENZOYL PEROXIDE gel
- NDC Code(s): 70771-1716-3, 70771-1716-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated June 6, 2022
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INGREDIENTS AND APPEARANCE
ADAPALENE AND BENZOYL PEROXIDE
adapalene and benzoyl peroxide gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1716 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE 3 mg in 1 g BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) POLOXAMER 124 (UNII: 1S66E28KXA) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (white to very pale yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1716-4 1 in 1 BOTTLE, PUMP 06/06/2022 1 45 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:70771-1716-3 1 in 1 BOTTLE, PUMP 06/06/2022 2 60 g 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 ANDA ANDA214553 06/06/2022 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1716) , MANUFACTURE(70771-1716)