Pregnancy: There are no adequate and well-controlled studies in pregnant women. Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral Shampoo 2% on the whole body. There are no known risks associated with the use of Nizoral Shampoo 2% in pregnancy.
Breast-feeding: There are no adequate and well-controlled studies in lactating women. There are no known risks associated with the use of Nizoral Shampoo 2% in lactation.