Naftin
NAFTIN NAFTIFINE HCl 1%
Approved
Approval ID
6371fceb-b98e-86a5-e053-2a91aa0a3d9e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2018
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 Code54766-770
Application NumberNDA019356
Product Classification
M
Marketing Category
C73594
G
Generic Name
NAFTIFINE HYDROCHLORIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 21, 2018
FDA Product Classification
INGREDIENTS (7)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
DIISOPROPANOLAMINEInactive
Code: 0W44HYL8T5
Classification: IACT
NAFTIFINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 g
Code: 25UR9N9041
Classification: ACTIB