FDA label b764d26c-4ea7-4aee-a1e8-b0409e9ec2ee

5 WARNINGS AND PRECAUTIONS If redness or irritation develops with the use of Naftifine Hydrochloride Cream, 2% treatment should be discontinued. ( 5.1 ) 5.1 Local Adverse Reactions If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream, 2% treatment should be discontinued. Patients should be directed to contact their physician if these conditions develop following use of Naftifine Hydrochloride Cream, 2%.

6 ADVERSE REACTIONS The most common adverse reaction (≥1%) is pruritus. ( 6.1 )To report SUSPECTED ADVERSE REACTIONS, contact Renaissaince Pharma, Inc at 1-877-622-2334 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical trials, 760 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 421 subjects with tinea pedis and/or tinea cruris were treated with Naftifine Hydrochloride Cream, 2%. In two randomized, vehicle-controlled trials (400 patients were treated with Naftifine Hydrochloride Cream, 2%. The population was 12 to 88 years old, primarily male (79%), 48% Caucasian, 36% Black or African American, 40% Hispanic or Latino and had either predominantly interdigital tinea pedis or tinea cruris. Most subjects received doses once-daily, topically, for 2 weeks to cover the affected skin areas plus a ½ inch margin of surrounding healthy skin. In the two vehicle-controlled trials, 17.5% of Naftifine Hydrochloride Cream, 2% treated subjects experienced an adverse reaction compared with 19.3% of vehicle subjects. The most common adverse reaction (≥1%) is pruritus. Most adverse reactions were mild in severity. The incidence of Adverse Reactions in the Naftifine Hydrochloride Cream, 2% treated population were not significantly different than the vehicle treated population. In an open-label pediatric pharmacokinetics and safety trial, 22 pediatric subjects 13-17 years of age with interdigital tinea pedis and tinea cruris received Naftifine Hydrochloride Cream, 2%. The incidence of adverse reactions in the pediatric population was similar to that observed in the adult population. 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of (naftifine hydrochloride): redness/irritation, inflammation, maceration, swelling, burning, blisters, serous drainage, crusting, headache, dizziness, leukopenia, agranulocytosis. 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.