Brand Name
Naftin
Generic Name
Naftifine
View Brand Information FDA approval date: January 06, 2016
Classification: Allylamine Antifungal
Form: Cream, Gel
What is Naftin (Naftifine)?
Naftifine hydrochloride cream is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum. Naftifine hydrochloride cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.
Approved To Treat
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Brand Information
Naftin (Naftifine Hydrochloride)
1INDICATIONS AND USAGE
NAFTIN
2DOSAGE AND ADMINISTRATION
Apply a thin layer of NAFTIN
For topical use only. NAFTIN
3DOSAGE FORMS AND STRENGTHS
Gel, 2%. Each gram contains 20 mg of naftifine hydrochloride in a colorless to yellow gel.
4CONTRAINDICATIONS
None.
5DESCRIPTION
NAFTIN
Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride.
The molecular formula is C
The structural formula of naftifine hydrochloride is
NAFTIN
6CLINICAL STUDIES
NAFTIN
The mean age of the study population was 45 years; 77% were male; and 60% were Caucasian, 35% were Black or African American, and 26% were Hispanic or Latino. At baseline, subjects were confirmed to have signs and symptoms of interdigital tinea pedis, positive KOH exam, and confirmed dermatophyte culture. The primary efficacy endpoint was the proportion of subjects with a complete cure at 6 weeks after the start of treatment (4 weeks after the last treatment). Complete cure was defined as both a clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture).
The efficacy results at week 6, four weeks following the end of treatment, are presented in Table 1 below.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
NAFTIN
8PATIENT COUNSELING INFORMATION
- Inform patients that NAFTIN
- Patients should be directed to contact their physician if irritation develops with the use of NAFTIN
9PRINCIPAL DISPLAY PANEL - 45g Tube Carton
NDC 54766-772-45
NAFTIN ®
Sebela Pharmaceuticals Inc.
For Topical Use Only
45g
10PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
NDC 54766-772-60
NAFTIN®
(Naftifine Hydrochloride) Gel, 2%
(Naftifine Hydrochloride) Gel, 2%
Sebela Pharmaceuticals Inc.
For Topical Use Only
Not for Ophthalmic, Oral or Intravaginal Use
Not for Ophthalmic, Oral or Intravaginal Use
60g
Rx Only
Rx Only