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, 0.3%/2.5%Initial U.S. Approval: 2015
Approved
Approval ID
92dcba02-f42f-482d-8cd5-2b5ab8fa540a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2022
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
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 Code45802-853
Application NumberANDA212464
Product Classification
M
Marketing Category
C73584
G
Generic Name
adapalene and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 2, 2022
FDA Product Classification
INGREDIENTS (12)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
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
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)Inactive
Code: 1DXE3F3OZX
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
POLOXAMER 124Inactive
Code: 1S66E28KXA
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT