CLOBEX
These highlights do not include all the information needed to use CLOBEX (clobetasol propionate) Spray, 0.05% safely and effectively. See full prescribing information for CLOBEX (clobetasol propionate) Spray, 0.05%. CLOBEX spray, for topical use. Initial U.S. Approval: 1985
Approved
Approval ID
aaba92a9-65fb-4150-aec0-9d9f721ca5a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2023
Manufacturers
FDA
Galderma Laboratories, L.P.
DUNS: 047350186
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 Code0299-3849
Application NumberNDA021835
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 9, 2023
FDA Product Classification
INGREDIENTS (5)
CLOBETASOL PROPIONATEActive
Quantity: 0.05 g in 1 mL
Code: 779619577M
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
UNDECYLENIC ACIDInactive
Code: K3D86KJ24N
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT