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
NDC Product Code66993-947
Application NumberNDA017765
Marketing CategoryC73605
Route of AdministrationTOPICAL
Effective DateAugust 29, 2019
Generic NameClocortolone Pivalate
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