EPIDUO
These highlights do not include all the information needed to use EPIDUO Gel safely and effectively. See full prescribing information for EPIDUO Gel. EPIDUO (adapalene and benzoyl peroxide) Gel 0.1%/2.5% For topical use Initial U.S. Approval: 2008
Approved
Approval ID
67002593-3bd3-4e91-a48f-9f7483e579a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5991
Application NumberNDA022320
Product Classification
M
Marketing Category
C73594
G
Generic Name
adapalene and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 7, 2012
FDA Product Classification
INGREDIENTS (11)
ADAPALENEActive
Quantity: 1 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIM
BENZOYL PEROXIDEActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIM
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
IsohexadecaneInactive
Code: 918X1OUF1E
Classification: IACT
docusate sodiumInactive
Code: F05Q2T2JA0
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
poloxamer 124Inactive
Code: 1S66E28KXA
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sorbitan MonooleateInactive
Code: 06XEA2VD56
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT