{"adverse_reactions":["ADVERSE REACTIONS During clinical trials with Naftifine Hydrochloride Cream, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%)."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, mutagenesis, impairment of fertility Long-term animal studies to evaluate the carcinogenic potential of Naftifine Hydrochloride Cream, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species, including Candida albicans . Naftifine Hydrochloride Cream, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE section. Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells. Pharmacokinetics In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Following a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days."],"contraindications":["CONTRAINDICATIONS Naftifine Hydrochloride Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components."],"description":["DESCRIPTION Naftifine Hydrochloride Cream, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Cream, 1% is for topical use only. Chemical Name (E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride. Naftifine hydrochloride has an empirical formula of C 21 H 21 N∙HCl and a molecular weight of 323.86. Chemical Structure Active Ingredient: Naftifine hydrochloride 1% Inactive Ingredients: benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION A sufficient quantity of Naftifine Hydrochloride Cream, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Cream, 1%, the patient should be re-evaluated."],"effective_time":"20150528","general_precautions":["General Naftifine Hydrochloride Cream, 1% is for external use only. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium."],"how_supplied":["HOW SUPPLIED Naftifine Hydrochloride 1% Cream is supplied in the following sizes: 30g—NDC 40085-201-30 (tube) 60g—NDC 40085-201-60 (tube) 90g—NDC 40085-201-90 (tube) Tubes: Store below 30° (86°F)."],"id":"00484c06-4cd0-4788-a4ce-1e21e50d6ae3","indications_and_usage":["INDICATIONS AND USAGE Naftifine Hydrochloride Cream, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum."],"information_for_patients":["Information for patients The patient should be told to: 1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician. 2. _Keep Naftifine Hydrochloride Cream, 1% away from the eyes, nose, mouth and other mucous membranes."],"nursing_mothers":["Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Hydrochloride Cream, 1% is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 g Tube Label NDC 40085- 201 -90 Naftifine HCl 1% Cream For Topical Use Only Not for Ophthalmic Use Renaissance Pharma 90 g Cream Rx Only PRINCIPAL DISPLAY PANEL - 90 g Tube Label"],"pediatric_use":["Pediatric use Safety and effectiveness in pediatric patients have not been established."],"pharmacokinetics":["Pharmacokinetics In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Following a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days."],"precautions":["PRECAUTIONS General Naftifine Hydrochloride Cream, 1% is for external use only. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Information for patients The patient should be told to: 1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician. 2. _Keep Naftifine Hydrochloride Cream, 1% away from the eyes, nose, mouth and other mucous membranes. Carcinogenesis, mutagenesis, impairment of fertility Long-term animal studies to evaluate the carcinogenic potential of Naftifine Hydrochloride Cream, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility. Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Hydrochloride Cream, 1% is administered to a nursing woman. Pediatric use Safety and effectiveness in pediatric patients have not been established."],"pregnancy":["Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."],"set_id":"ee46c902-8a59-40f7-ac99-e96a8b981d60","spl_product_data_elements":["Naftifine Hydrochloride NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE NAFTIFINE Water Isopropyl Myristate Polysorbate 60 Stearyl Alcohol Cetyl Alcohol Cetyl Esters Wax Sorbitan Monostearate Benzyl Alcohol"],"spl_unclassified_section":["Rx Only","Manufactured for: Renaissance Pharma, Inc. Newtown, PA 18940 Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 140364 Printed in U.S.A. Iss. 10/2014"],"storage_and_handling":["Tubes: Store below 30° (86°F)."],"teratogenic_effects":["Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."],"version":"3","warnings":["WARNINGS Naftifine Hydrochloride Cream, 1% is for topical use only and not for ophthalmic use."]}