PRESCRIBING INFORMATION

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.

Important Safety Information

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.

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