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Pregnancy: There are no adequate and well-controlled studies in pregnant women. At clinically relevant exposures, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of DAKTARIN Oral Gel during pregnancy unless the benefit of therapy to the patient is considered to outweigh the risks to the fetus.
Breast-feeding: It is not known whether miconazole or its metabolites are excreted in human milk (see Precautions).
