Spectazole (Econazole Nitrate) - Indications and Dosage

INDICATIONS AND USAGE:

SPECTAZOLE Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

DOSAGE AND ADMINISTRATION:

Sufficient SPECTAZOLE Cream should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.

Early relief of symptoms is experienced by the majority of patients and 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 and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

HOW SUPPLIED:

SPECTAZOLE (econazole nitrate 1%) Cream is supplied in tubes of 15 grams (NDC 0062-5460-02), 30 grams (NDC 0062-5460-01), and 85 grams (NDC 0062-5460-03).

Store SPECTAZOLE Cream below 86°F.

Ortho Dermatological, Division of
Ortho-McNeil Pharmaceutical, Inc.
Skillman, New Jersey 08558

© OMP 2001
Printed in U.S.A
Rev January 2001
631-11-331-1