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Taclonex Scalp

These highlights do not include all the information needed to use Taclonex Scalp® Topical Suspension safely and effectively. See full prescribing information for Taclonex Scalp® Topical Suspension. Initial U.S. Approval: 2006

Approved
Approval ID

d61c7acb-a64f-46ee-b125-0c80d3b35585

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 18, 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.

calcipotriene and betamethasone dipropionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6091
Application NumberNDA022185
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcipotriene and betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 18, 2010
FDA Product Classification

INGREDIENTS (4)

MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CALCIPOTRIENEActive
Quantity: 50 ug in 1 g
Code: 143NQ3779B
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.643 mg in 1 g
Code: 826Y60901U
Classification: ACTIB

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Taclonex Scalp - FDA Drug Approval Details