Nizoral 2% cream

NIZORAL (ketoconazole) 2% Cream is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

NIZORAL (ketoconazole) 2% Cream is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that NIZORAL (ketoconazole) 2% Cream be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.

Seborrheic dermatitis: NIZORAL (ketoconazole) 2% Cream should be applied to the affected area twice daily for four weeks or until clinical clearing.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

NIZORAL (ketoconazole) 2% Cream is supplied in 15 (NDC 50458-221-15), 30 (NDC 50458-221-30) and 60 (NDC 50458-221-60) gm tubes.

Store below 77°F (25°C)

Revised July 1994, April 1995

U.S. Patent No. 4,335,125

Janssen Pharmaceutica Products, L.P. 1996