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
NDC Product Code76420-509
Application NumberANDA200734
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateDecember 16, 2023
Generic NameFluocinonide
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