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Oxistat

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Oxistat

INDICATIONS

OXISTAT (oxiconazole) Cream and Lotion are 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. OXISTAT (oxiconazole) Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and Clinical Studies).

OXISTAT (oxiconazole) Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT (oxiconazole) Cream has been shown to be effective rarely occur in children below the age of 12.

DOSAGE AND ADMINISTRATION

OXISTAT (oxiconazole) Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. OXISTAT (oxiconazole) Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

HOW SUPPLIED

OXISTAT (oxiconazole) Cream, 1% is supplied in 15-g tubes (NDC 0173-0423-00), 30-g tubes (NDC 0173-0423-01), and 60-g tubes (NDC 0173-0423-04). Store between 15° and 30°C (59° and 86°F).

OXISTAT (oxiconazole) Lotion, 1% is supplied in a 30-mL bottle (NDC 0173-0448-01). Store between 15° and 30°C (59° and 86°F). Shake well before using.

GlaxoSmithKline Consumer Healthcare LP Pittsburgh, PA 15230. January 23, 2004. FDA revision date: 1/23/2004

Last reviewed on RxList: 5/5/2008
This monograph has been modified to include the generic and brand name in many instances.

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