MedPath

DIFFERIN

These highlights do not include all the information needed to use DIFFERIN Gel safely and effectively. See full prescribing information for DIFFERIN Gel.DIFFERIN® (adapalene) gel, for topical useInitial U.S. Approval: 1996

Approved
Approval ID

a0031324-92a6-4c11-90e2-c2818f7278ec

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2023

Manufacturers
FDA

Galderma Laboratories, L.P.

DUNS: 047350186

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

adapalene

PRODUCT DETAILS

NDC Product Code0299-5918
Application NumberNDA021753
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateDecember 28, 2023
Generic Nameadapalene

INGREDIENTS (9)

AdapaleneActive
Quantity: 3 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Carbomer Homopolymer Type CInactive
Code: 4Q93RCW27E
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Poloxamer 124Inactive
Code: 1S66E28KXA
Classification: IACT

Drug Labeling Information

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 12/28/2023

4 CONTRAINDICATIONS

DIFFERIN Gel is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of DIFFERIN Gel [see WARNINGS AND PRECAUTIONS (5.1)].

Key Highlight

Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of DIFFERIN Gel. (4)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.