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FDA Approval

Naftin

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

December 22, 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Naftifine(10 mg in 1 g)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Naftin

NDC Product Code

54868-2240

Application Number

NDA019599

Marketing Category

NDA (C73594)

Route of Administration

TOPICAL

Effective Date

July 1, 2010

Ingredients

NaftifineActive

Code: 25UR9N9041Class: ACTIMQuantity: 10 mg in 1 g

CETYL ALCOHOLInactive

Code: 936JST6JCNClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

ISOPROPYL MYRISTATEInactive

Code: 0RE8K4LNJSClass: IACT

POLYSORBATE 60Inactive

Code: CAL22UVI4MClass: IACT

STEARYL ALCOHOLInactive

Code: 2KR89I4H1YClass: IACT

SORBITAN MONOSTEARATEInactive

Code: NVZ4I0H58XClass: IACT

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