Ertaczo
INDICATIONS
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).
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.
HOW SUPPLIED
ERTACZO™ Cream, 2%, is supplied in tubes in the following sizes:
| 15-gram tube | NDC 62794-170-46 |
| 30-gram tube | NDC 62794-170-43 |
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Manufactured By: DPT Laboratories Inc.
San Antonio, TX 78215
Distributed By: Bertek Pharmaceuticals Inc.
Research Triangle Park, NC 27709
BERTEK™ Bertek Pharmaceuticals Inc.
Research Triangle Park, NC 27709
Revised December 9, 2003
STZC:R1
FDA revision date: 11/22/05.
Generic Name: Sertaconazole Nitrate
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Ertaczo
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