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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0299-5918
Application NumberNDA021753
Product Classification
M
Marketing Category
C73594
G
Generic Name
adapalene
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 28, 2023
FDA Product Classification

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)

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DIFFERIN - FDA Drug Approval Details