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Coal tar safety

This article was originally published in The Tan Sheet

Executive Summary

FDA asked to conduct "formal review" of coal tar use in shampoo, soap and ointments by Occupational Knowledge International in a March 6 petition. The agency should "restrict the sales and distribution of these products to prescription sales," the group states. As a "known carcinogen...labeling requirements are insufficient and require additional warning to protect public health." Coal tar, which appears in Whitehall-Robins' Denorex and Block Drug's Tegrin, was banned from use in OTC drug products by Germany in 1995 and the EU in 1997, the comments point out

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Coal tar

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Coal tar

Animal data on carcinogenic risk of dandruff shampoo ingredient insufficient to support a change in OTC monograph status or new labeling warnings, J&J subsidiary Neutrogena asserts in recent comments to FDA. Stressing its opposition to restrictions on coal tar-containing OTCs requested by Occupational Knowledge International (OKI) in a March petition, the T/Gel marketer also notes the research cited by the petitioners examined "coal tar oil, not coal tar" (1"The Tan Sheet" April 3, In Brief). Neutrogena is one of several defendants in the Prop 65 lawsuit over coal tar in OTCs brought by OKI and California Attorney General Bill Lockyer

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