Clocortolone Pivalate Cream
Clocortolone Pivalate Cream, 0.1%
Approved
Approval ID
5128dcfc-afbe-44b0-aab7-ce5e8e9978fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2019
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clocortolone Pivalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-947
Application NumberNDA017765
Product Classification
M
Marketing Category
C73605
G
Generic Name
Clocortolone Pivalate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 29, 2019
FDA Product Classification
INGREDIENTS (11)
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
clocortolone pivalateActive
Quantity: 1 mg in 1 g
Code: QBL8IZH14X
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT