Naftin
These highlights do not include all the information needed to use NAFTIN Gel, 2% safely and effectively. See full prescribing information for NAFTIN (naftifine hydrochloride) Gel, 2%. NAFTIN (naftifine hydrochloride) gel, for topical use Initial U.S. Approval: 1988
Approved
Approval ID
6645994a-ecb3-277b-e053-2a91aa0a81e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Sebela Pharmaceuticals Inc.
DUNS: 079104574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naftifine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54766-772
Application NumberNDA204286
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naftifine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
NAFTIFINE HYDROCHLORIDEActive
Quantity: 2 g in 100 g
Code: 25UR9N9041
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT