MedPath
FDA Approval

Naftin

December 12, 2023

HUMAN PRESCRIPTION DRUG LABEL

Naftifine(2 g in 100 g)

Manufacturing Establishments (1)

Ferndale Laboratories, Inc.

Sebela Pharmaceuticals Inc.

005320536

Products (1)

Naftin

54766-772

NDA204286

NDA (C73594)

TOPICAL

December 12, 2023

WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
NaftifineActive
Code: 25UR9N9041Class: ACTIBQuantity: 2 g in 100 g
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
TROLAMINEInactive
Code: 9O3K93S3TKClass: IACT
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