Adapalene and Benzoyl Peroxide
These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE AND BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015
Approved
Approval ID
13fc72e9-7178-4a8b-9fe8-d88ba591dac8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2022
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ADAPALENE and BENZOYL PEROXIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-1384
Application NumberANDA209148
Product Classification
M
Marketing Category
C73584
G
Generic Name
ADAPALENE and BENZOYL PEROXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 27, 2022
FDA Product Classification
INGREDIENTS (9)
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
ADAPALENEActive
Quantity: 3 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
BENZOYL PEROXIDEActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
poloxamer 124Inactive
Code: 1S66E28KXA
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)Inactive
Code: 5F4963KLHS
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT