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
NDC Product Code0299-3849
Application NumberNDA021835
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateMay 9, 2023
Generic Nameclobetasol propionate
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