Impoyz
These highlights do not include all the information needed to use IMPOYZ Cream safely and effectively. See full prescribing information for IMPOYZ Cream. IMPOYZ (clobetasol propionate) Cream, 0.025%, for topical use Initial U.S. Approval: 1985
Approved
Approval ID
40173654-334e-4618-847b-6a1e030cd2fd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2024
Manufacturers
FDA
Primus Pharmaceuticals, Inc.
DUNS: 130834745
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clobetasol propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68040-713
Application NumberNDA209483
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 30, 2024
FDA Product Classification
INGREDIENTS (12)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CLOBETASOL PROPIONATEActive
Quantity: 0.25 mg in 1 g
Code: 779619577M
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT