In controlled clinical trials, 9 (approximately 1%) of 815 patients treated with Mentax® (butenafine) Cream, 1%, reported adverse events related to the skin. These included burning/stinging, itching, and worsening of the condition. No patient treated with Mentax® (butenafine) Cream, 1%, discontinued treatment due to an adverse event. In the vehicle-treated patients, two of 718 patients discontinued because of treatment-site adverse events, one of which was severe burning/stinging and itching at the site of application.
In uncontrolled clinical trials, the most frequently reported adverse events in patients treated with Mentax® (butenafine) Cream, 1%, were: contact dermatitis, erythema, irritation, and itching, each occurring in less than 2% of patients.
In provocative testing in over 200 subjects, there was no evidence of allergic contact sensitization for either the cream or the vehicle base for Mentax® (butenafine) Cream, 1%.