Clobex
Approved
Approval ID
c77ababd-a449-4e89-a9c6-b7e401120ba1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2010
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 Code54868-5510
Application NumberNDA021835
Product Classification
M
Marketing Category
C73594
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 21, 2011
FDA Product Classification
INGREDIENTS (5)
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 mL
Code: 779619577M
Classification: ACTIM
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
UNDECYLENIC ACIDInactive
Code: K3D86KJ24N
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT