Nizoral Shampoo (Ketoconazole Shampoo) - Indications and Dosage

INDICATIONS AND USAGE

NIZORAL® (ketoconazole) 2% Shampoo is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization 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 versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

DOSAGE AND ADMINISTRATION

Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water.

One application of the shampoo should be sufficient.

HOW SUPPLIED

NIZORAL® (ketoconazole) 2% Shampoo is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 50580-380-08).

Storage conditions: Store at a temperature not above 25°C (77°F). Protect from light.

Rx only.

Distributed by:

McNeil Consumer & Specialty Pharmaceuticals

DIVISION OF MCNEIL – PPC, INC.

FORT WASHINGTON, PA 19034 USA

© MCN-PPC, Inc. '04

Rev August 1997, May 1999, October 2003

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

3002937