Naftin
NAFTIN NAFTIFINE HCl 1% GEL
Approved
Approval ID
c8c13708-b35c-40bf-a911-12e4cffef2a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2185
Application NumberNDA019356
Product Classification
M
Marketing Category
C73594
G
Generic Name
naftifine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 4, 2013
FDA Product Classification
INGREDIENTS (5)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
NAFTIFINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 g
Code: 25UR9N9041
Classification: ACTIB
DIISOPROPANOLAMINEInactive
Code: 0W44HYL8T5
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT