Taclonex
These highlights do not include all the information needed to use Taclonex Ointment safely and effectively. See Full Prescribing Information for Taclonex Ointment. Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment For topical use only Initial U.S. Approval: 2006.
Approved
Approval ID
4fe9ed32-0843-4a05-a5f2-d2e6325bbb9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 29, 2012
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.
calcipotriene and betamethasone dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5680
Application NumberNDA021852
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcipotriene and betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 29, 2012
FDA Product Classification
INGREDIENTS (5)
ALPHA-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CALCIPOTRIENE HYDRATEActive
Quantity: 50 ug in 1 g
Code: S7499TYY6G
Classification: ACTIM