Oxistat

Oxistat

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Questions & Answers

Side Effects & Adverse Reactions

OXISTAT® (oxiconazole nitrate cream)Cream, 1% and OXISTAT® (oxiconazole nitrate lotion) Lotion, 1% are not for ophthalmic or intravaginal use.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

OXISTAT® 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® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).

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

History

There is currently no drug history available for this drug.

Other Information

OXISTAT® (oxiconazole nitrate cream) Cream, 1% and OXISTAT® (oxiconazole nitrate lotion) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are for topical dermatologic use only.

Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone (Z)-[0-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C18H13ON3CI4·HNO3, a molecular weight of 492.15, and the following structural formula:

Structural Formula

Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water.

OXISTAT® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.

OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.

Oxistat Manufacturers


  • Rebel Distributors Corp.
    Oxistat (Oxiconazole Nitrate) Lotion [Rebel Distributors Corp.]
  • Pharmaderm, A Division Of Nycomed Us Inc.
    Oxistat (Oxiconazole Nitrate) Cream Oxistat (Oxiconazole Nitrate) Lotion [Pharmaderm, A Division Of Nycomed Us Inc.]
  • Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
    Oxistat (Oxiconazole Nitrate) Cream Oxistat (Oxiconazole Nitrate) Lotion [Pharmaderm A Division Of Fougera Pharmaceuticals Inc.]

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