For external use only. This preparation should not be used in or near the eyes or on mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy. After the reaction clears, treatment may often be resumed with less frequent application.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Data from several studies using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown.
Pregnancy: Pregnancy Category C
Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no data available on the effect of benzoyl peroxide on the growth, development and functional maturation of the unborn child.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.
Safety and effectiveness in pedi-atric patients have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/21/2011
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