Salitop Lotion

For external use only. Avoid contact with eyes and other mucous membranes.

Pregnancy (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salitop™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salitop™, a decision should be make whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salitop™. It has been shown to lack mutagenic potential in the Ames Salmonella test.