Clobex
Approved
Approval ID
a086ead1-b906-4198-af19-5423957c9e2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5657
Application NumberNDA021535
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 7, 2011
FDA Product Classification
INGREDIENTS (6)
CLOBETASOL PROPIONATEActive
Quantity: 0.05 mL in 100 mL
Code: 779619577M
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CARBOMER 1342Inactive
Code: 809Y72KV36
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT