Ertaczo® (sertaconazole nitrate) Cream 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older.
Details below are provided from the product labeling.
Ertaczo® (sertaconazole nitrate) Cream 2% is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Apply a sufficient amount of Ertaczo Cream 2% twice daily for 4 weeks to the affected areas between the toes and the immediately surrounding healthy skin. Dry the affected area thoroughly before application. Continue for the full treatment duration even if symptoms improve. Wash hands after use.
For topical use only. Not for ophthalmic, oral, or intravaginal use. Do not use with occlusive dressings.
None.
In clinical trials, cutaneous adverse events occurred in 7 of 297 subjects (2%) receiving sertaconazole cream and 7 of 291 subjects (2%) receiving vehicle. Reported events included contact dermatitis, dry skin, burning, and application site tenderness. Post-marketing reports include erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Ertaczo Cream 2% is a white cream. Each gram contains 17.5 mg of sertaconazole (as 20 mg sertaconazole nitrate).
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Full Prescribing Information: Dailymed