Fluocinonide
These highlights do not include all the information needed to use fluocinonide cream USP, 0.1% safely and effectively. See full prescribing information for fluocinonide cream USP, 0.1%. Fluocinonide Cream USP, 0.1% For topical use Initial U.S. Approval: 1971
Approved
Approval ID
cd5d8268-77ff-41c0-8699-b583e52da30c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2023
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-509
Application NumberANDA200734
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (9)
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
FLUOCINONIDEActive
Quantity: 1 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB