Naftin
NAFTIN NAFTIFINE HCl 1%
Approved
Approval ID
f4b6c5d8-615c-47d6-8ad9-523c7ab146af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2013
Manufacturers
FDA
Merz Pharmaceuticals, LLC
DUNS: 126209282
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 Code0259-4126
Application NumberNDA019599
Product Classification
M
Marketing Category
C73594
G
Generic Name
NAFTIFINE HYDROCHLORIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 25, 2013
FDA Product Classification
INGREDIENTS (9)
NAFTIFINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 g
Code: 25UR9N9041
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Isopropyl MyristateInactive
Code: 0RE8K4LNJS
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Cetyl Esters WaxInactive
Code: D072FFP9GU
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT