<p><strong>Pregnancy</strong>: There are no available data on the use of ozenoxacin in pregnant women to inform a drug associated risk. Systemic absorption of ozenoxacin in humans is negligible following topical administration of ozenoxacin (up to twice the concentration of the marketed formulation). Due to the negligible systemic exposure, it is not expected that maternal use of ozenoxacin will result in fetal exposure to the drug. Animal reproduction studies were not conducted with ozenoxacin. However, toxicity studies conducted in pregnant rats and rabbits administered the oral form of ozenoxacin showed no significant adverse developmental effects (at &gt;10,000 times the maximum human plasma concentration seen with dermal application of ozenoxacin). The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.<br />
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<strong>Lactation</strong>: No data are available regarding the presence of ozenoxacin in human milk, and the effects of ozenoxacin on the breastfed infant or on milk production. However, breastfeeding is not expected to result in exposure of the child to ozenoxacin due to the negligible systemic absorption of ozenoxacin in humans following topical administration of ozenoxacin. The developmental and health benefits of breastfeeding should be considered along with the mother&rsquo;s clinical need for ozenoxacin and any potential adverse effects on the breast-fed child from ozenoxacin or from the underlying maternal condition.</p>