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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 (see CLINICAL STUDIES Section).
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DOSAGE AND ADMINISTRATION
In the treatment of interdigital tinea pedis, ERTACZO® Cream, 2%, should be applied twice daily for 4 weeks. Sufficient ERTACZO® Cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. If a patient shows no clinical improvement 2 weeks after the treatment period, the diagnosis should be reviewed.
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HOW SUPPLIED
ERTACZO® Cream, 2%, is supplied in tubes in the following size:
- 30-gram tube NDC 0062-1650-03
- 60-gram tube NDC 0062-1650-02
Store at 25°C (77°F); excursions permitted to 15º-30°C (59º-86°F) [see USP Controlled Room Temperature].
Rx only.
Patent No. 5,135,943
Distributed By: OrthoNeutrogena
DIVISION OF ORTHO-McNEIL PHARMACEUTICAL, INC.
Los Angeles, CA 90045
Rev November 2005
128354
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