Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Oxiconazole nitrate cream, 1% is supplied in: 30 g tubes NDC 0168-0358-30, 60 g tubes NDC 0168-0358-60, 90 g tubes NDC 0168-0358-90. Store between 15° and 30°C (59° and 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46144436A R09/14 #316; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CONTAINER NDC 0168-0358-30 OXICONAZOLE NITRATE CREAM, 1% * * Potency expressed as oxiconazole. For Topical Dermatologic Use ONLY - Not for Ophthalmic or Intravaginal Use. Rx Only NET WT 30 grams container; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON NDC 0168-0358-30 Rx Only OXICONAZOLE NITRATE CREAM, 1% * * Potency expressed as oxiconazole. For Topical Dermatologic Use ONLY - Not for Ophthalmic or Intravaginal Use. NET WT 30 grams Carton30g
- HOW SUPPLIED Oxiconazole nitrate cream, 1% is supplied in: 30 g tubes NDC 0168-0358-30, 60 g tubes NDC 0168-0358-60, 90 g tubes NDC 0168-0358-90. Store between 15° and 30°C (59° and 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46144436A R09/14 #316
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CONTAINER NDC 0168-0358-30 OXICONAZOLE NITRATE CREAM, 1% * * Potency expressed as oxiconazole. For Topical Dermatologic Use ONLY - Not for Ophthalmic or Intravaginal Use. Rx Only NET WT 30 grams container
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON NDC 0168-0358-30 Rx Only OXICONAZOLE NITRATE CREAM, 1% * * Potency expressed as oxiconazole. For Topical Dermatologic Use ONLY - Not for Ophthalmic or Intravaginal Use. NET WT 30 grams Carton30g
Overview
Oxiconazole nitrate cream, 1% contains the antifungal active compound oxiconazole nitrate. This formulation is 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 C 18 H 13 ON 3 CI 4 •HNO 3 , a molecular weight of 492.15, and the following 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. Oxiconazole nitrate 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. chemicalstructure
Indications & 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.
Dosage & Administration
Oxiconazole nitrate cream should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole nitrate 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.
Warnings & Precautions
WARNINGS Oxiconazole nitrate cream, 1% is not for ophthalmic or intravaginal use.
Contraindications
Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.
Adverse Reactions
During clinical trials, of 955 patients treated with oxiconazole nitrate cream, 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each).
Drug Interactions
Potential drug interactions between oxiconazole nitrate and other drugs have not been systematically evaluated. Drug Interactions: Potential drug interactions between oxiconazole nitrate and other drugs have not been systematically evaluated.
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