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There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical Ketoconazole on pregnancy or on the health of the fetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of Ketoconazole.
Plasma concentrations of Ketoconazole are not detectable after topical application of Ketoconazole 2% Cream to the skin of non-pregnant humans. There are no known risks associated with the use of Ketoconazole 2% Cream in pregnancy or lactation.
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