<p>Pregnancy Category B. There is inadequate evidence of the safety of topically applied Isotretinoin in human pregnancy. Isotretinoin has been associated with teratogenicity in humans when administered systemically. Reproduction studies conducted in rabbits using Isotretinoin applied topically at up to 60 times the human dose have, however, revealed no harm to the foetus. The use of Isotretinoin should be avoided during pregnancy. Percutaneous absorption of Isotretinoin from Isotretinoin 0.05% gel is negligible. It is not known, however, whether Isotretinoin is excreted in human milk. Isotretinoin should not be used during lactation.</p>