Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE GEL. ADAPALENE AND BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2008
Approved
Approval ID
06862a25-6e7c-4633-b611-0836151218bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2024
Manufacturers
FDA
GABAR HEALTH SCIENCES CORP
DUNS: 118401847
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 Gel, 0.1%/2.5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82429-313
Application NumberANDA206164
Product Classification
M
Marketing Category
C73584
G
Generic Name
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (13)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
POLOXAMER 182Inactive
Code: JX0HIX6OAG
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
LIMONENE, (+)-Inactive
Code: GFD7C86Q1W
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ADAPALENEActive
Quantity: 1 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
BENZOYL PEROXIDEActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB