(72) 11 (16) Interdigital Tinea Pedis Naftin Cream has been investigated for. Long-term studies to evaluate the risk of cancer from naftin Gel, 2 have not been done. At baseline, subjects were confirmed to have signs and symptoms of tinea cruris, positive KOH exam, and confirmed dermatophyte presence based on culture results from a central mycology laboratory. All subjects showed measurable levels of naftifine in plasma after topical application of Naftin Cream. Accessed August 11, 2018. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Each gram of (naftifine hydrochloride) Cream contains 20 mg of naftifine hydrochloride (2 a synthetic allylamine antifungal compound. Naftin Cream is not intended for oral, intravaginal or ophthalmic use.
The NDC s for Naftin changed in February 2018.
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A peri- and post-natal development study was conducted in rats. Subjects were treated with a median dose.1 g (range.6-10.1 g) applied to the affected areas once daily for 2 weeks. For the comparison of animal to human doses based on body surface area comparison (mg/m 2 the mrhd is set at 8 g 2 cream per day (2.67 mg/kg/day for a 60 kg individual). Subcutaneous doses of 10 and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. Complete cure was defined as both clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture). Ever Miss a Dose of Your Medicine? Median fraction of the dose excreted in urine during the treatment period was.0030 on Day 1 and.0033 on Day.