Clobex
These highlights do not include all the information needed to use CLOBEX Shampoo safely and effectively. See full prescribing information for CLOBEX Shampoo. CLOBEX (clobetasol propionate) Shampoo, 0.05% for topical useInitial U.S. Approval: 1985
Approved
Approval ID
acb3a25e-5746-4df6-89fd-cf3023e755cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 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 Code0299-3847
Application NumberNDA021644
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 21, 2023
FDA Product Classification
INGREDIENTS (8)
Clobetasol propionateActive
Quantity: 0.05 g in 100 mL
Code: 779619577M
Classification: ACTIB
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT
POLYQUATERNIUM-10 (400 CPS AT 2%)Inactive
Code: HB1401PQFS
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
COCO-BETAINEInactive
Code: 03DH2IZ3FY
Classification: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT