oxiconazole nitrate

FDA Drug Profile — Oxistat

Drug Details

Generic Name
oxiconazole nitrate
Brand Names
Oxistat
Application Number
NDA020209
Sponsor
ANI Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
OXICONAZOLE NITRATE

Indications and Usage

INDICATIONS AND USAGE Oxiconazole nitrate cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ). Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12.

Warnings

WARNINGS Oxiconazole nitrate cream, 1% is not for ophthalmic or intravaginal use.