Naftifine hydrochloride
These highlights do not include all the information needed to use NAFTIFINE HYDROCHLORIDE CREAM safely and effectively. See full prescribing information for NAFTIFINE HYDROCHLORIDE CREAM. NAFTIFINE HYDROCHLORIDE cream, 2%, for topical use Initial U.S. Approval: 1988
Approved
Approval ID
567f7418-e65c-740f-6233-741f5274fe1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2021
Manufacturers
FDA
Xiromed, LLC
DUNS: 080228637
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 Code70700-161
Application NumberANDA210038
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naftifine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 15, 2021
FDA Product Classification
INGREDIENTS (11)
NAFTIFINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 g
Code: 25UR9N9041
Classification: ACTIB
CETYL ESTERS WAXInactive
Code: D072FFP9GU
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT