This topical preparation contains the antifungal active compound Oxiconazole Nitrate. For topical dermatological use only. Oxiconazole Nitrate is an imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity. It has in vitro activity against a wide range of pathogenic fungi. Oxiconazole has been shown to be active against most strains of the following organisms both in vitro and in clinical infections at indicated body sites: Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum, Malassezia furfur. Oxiconazole exhibits satisfactory in vitro minimum inhibitory concentrations (MICs) against most strains of the following organisms: Microsporum audouini, Microsporum canis, Microsporum gypseum, Trichophyton tonsurans,Trichophyton violaceum.

Oxiconazole topical preparation 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 Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur.

This topical preparation should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. 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.

Administration

• Use Oxiconazole topical preparation as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, nose, mouth, and other mucous membranes. Oxiconazole cream isfor external use only.
• Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after 2 to 4 weeks orsooner if the condition worsens.
• Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing.
• Avoid the use of occlusive dressings unless otherwise directed by the physician.
• Do not use this medication for any disorder other than that for which it was prescribed

Oxiconazole topical preparation is contraindicated in individuals who have shown previous hypersensitivity to Oxiconazole

Pruritus, burning, irritation and allergic contact dermatitis, folliculitis, erythema, and papules, fissure, maceration, rash, stinging and nodules.

Oxiconazole topical preparation is not for ophthalmic or intravaginal use.

Pregnancy & Lactation

Pregnancy category B. Because Oxiconazole Nitrate is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.