Naftifine Hydrochloride
These highlights do not include all the information needed to use NAFTIFINE HYDROCHLORIDE GEL safely and effectively. See full prescribing information for NAFTIFINE HYDROCHLORIDE GEL. NAFTIFINE HYDROCHLORIDE gel, for topical use Initial U.S. Approval: 1988
Approved
Approval ID
92d3ec30-2176-49cd-8a70-668ef65e7663
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2023
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-1376
Application NumberANDA208201
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naftifine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 3, 2023
FDA Product Classification
INGREDIENTS (9)
Naftifine HydrochlorideActive
Quantity: 20 mg in 1 g
Code: 25UR9N9041
Classification: ACTIB
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
hydroxyethyl cellulose (2000 MPA.S at 1%)Inactive
Code: S38J6RZN16
Classification: IACT
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
trolamineInactive
Code: 9O3K93S3TK
Classification: IACT