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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.
NIZORAL® (ketoconazole) 2% Shampoo is a red-orange liquid supplied in a 4-fluid ounce (120 mL) nonbreakable plastic bottle (NDC 50458-680-08).
Store at a temperature not above 25°C (77°F). Protect from light. Product of Belgium
Manufactured by: Janssen Pharmaceutica N.V. Beerse, Belgium Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. Revised: December 2012
Last reviewed on RxList: 12/14/2012
This monograph has been modified to include the generic and brand name in many instances.
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