Mentax® (butenafine HCl cream) Cream, 1%, is not for ophthalmic, oral, or intravaginal use.

General

Mentax® Cream, 1%, is for external use only. If irritation or sensitivity develops with the use of Mentax® Cream, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by culture on an appropriate medium, [except M. furfur (formerly P. orbiculare)] or by direct microscopic examination of infected superficial epidermal tissue in a solution of potassium hydroxide.

Patients who are known to be sensitive to allylamine antifungals should use Mentax® (butenafine HCl cream) Cream, 1%, with caution, since cross-reactivity may occur.

Use Mentax® Cream, 1%, as directed by the physician, and avoid contact with the eyes, nose, and mouth, and other mucous membranes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of Mentax® Cream, 1%, have not been conducted. Two in vitro assays (bacterial reverse mutation test and chromosome aberration test in Chinese hamster lymphocytes) and one in vivo study (rat micronucleus bioassay) revealed no mutagenic or clastogenic potential for butenafine.

In subcutaneous reproductive studies in rats at 25 mg/kg/day (6 times the maximum possible systemic dose) in humans based on a mg/m² comparison) dose level, butenafine did not produce any adverse effects on male or female fertility.

Pregnancy

Teratogenic Effects:  Pregnancy Category B

Subcutaneous or topical doses of butenafine (25 to 50 mg/kg/day) (equivalent to 5 to 20 times the maximum possible systemic dose in humans based on a mg/m² comparison) were not teratogenic in rats and rabbits. In an oral teratogenicity study in rabbits (80, 200, and 400 mg butenafine HCl/kg/day) (equivalent to 3 to 16 times the maximum possible systemic dose in humans based on a mg/m² comparison), no treatment-related external, visceral, or skeletal malformations or variations were observed. There are, however, no adequate and well-controlled studies that have been conducted of topically-applied butenafine 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 if butenafine HCl is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing Mentax® Cream, 1%, to a nursing women.

Pediatric Use

Safety and efficacy in pediatric patients below the age of 12 years have not been studied. Use of Mentax® Cream, 1%, in pediatric patients 12 to 16 years of age is supported by evidence from adequate and well-controlled studies of Mentax® Cream, 1%, in adults.

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