2% cream, 30 g and 60 g
Indications and Usage:
ERTACZO (sertaconazole nitrate) Cream, 2% is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Side Effects and Contraindications:
ERTACZO (sertaconazole nitrate) Cream, 2% is contraindicated in individuals who have a known or suspected sensitivity to sertaconazole nitrate, any of its components or other imidazoles. ERTACZO is indicated for topical use only and is not indicated for ophthalmic, oral or intravaginal use. If irritation or sensitivity develops with the use of ERTACZO, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of infected superficial epidermal tissue in a solution of potassium hydroxide or by culture on an appropriate medium. In clinical trials, cutaneous adverse events occurred in 2% of patients receiving ERTACZO and in 2% of patients receiving vehicle. These reported adverse events included contact dermatitis, dry skin, burning skin, application site reaction and skin tenderness.
Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC.