Natroba Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: B
Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
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Natroba Breastfeeding Warnings
This drug is not systemically absorbed after topical use; it should not be present in human milk.
The topical suspension contains benzyl alcohol, which may be systemically absorbed through the skin; the amount excreted into human milk with use of this drug is unknown.
Caution is recommended.
Excreted into human milk: No (active component); Yes (benzyl alcohol)
Comments:
-High amounts of benzyl alcohol are potentially harmful to neonates; it is unlikely that levels this high reach breast milk.
-Lactating women may choose to pump and discard breast milk for 8 hours (5 half-lives of benzyl alcohol) after use to avoid infant ingestion of benzyl alcohol.
See references