In controlled clinical trials, 9 (approximately 1%) of 815 patients treated with Mentax® Cream, 1%, reported adverse events related to the skin. These included burning/stinging and worsening of the condition. No patient treated with Mentax® Cream, 1%, discontinued treatment due to an adverse event. In the vehicle-treated patients, 2 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® 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® Cream, 1%.

Potential drug interactions between Mentax® (butenafine HCl cream) Cream, 1%, and other drugs have not been systematically evaluated.

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