adapalene and benzoyl peroxide
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 topical gel 0.3%/2.5%Initial U.S. Approval: 2015
Approved
Approval ID
56541736-c70e-4fcd-9614-6cfdc5044136
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2022
Manufacturers
FDA
Mayne Pharma Inc.
DUNS: 867220261
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 Code68308-662
Application NumberNDA207917
Product Classification
M
Marketing Category
C73605
G
Generic Name
adapalene and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (12)
ADAPALENEActive
Quantity: 3 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)Inactive
Code: M4PPW69Y4H
Classification: IACT
BENZOYL PEROXIDEActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLOXAMER 124Inactive
Code: 1S66E28KXA
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT