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SOLARCAINE SEVERE SUNBURN RELIEF SPRAY "SERIOUSLY MISBRANDED"

Executive Summary

SOLARCAINE SEVERE SUNBURN RELIEF SPRAY "SERIOUSLY MISBRANDED" and subject to possible enforcement action, FDA told Schering-Plough in a Nov. 5 reg letter. The agency said it considers the lidocaine/aloe vera product "seriously misbranded" in that it "is not aware of any substantial scientific evidence which establishes that a formulation of lidocaine, aloe vera and other ingredients...are generally recognized as safe and effective [GRAS/E] for the treatment of severe sunburn and severe sunburn pain and healing sun damaged skin." The 2% lidocaine product is new this year. The 1983 OTC External Analgesic Drug Products TFM lists 0.5% to 4% lidocaine as GRAS/E for "the temporary relief of pain...associated with minor burns [and] sunburn," FDA noted. In addition, FDA said it is not aware of any OTC drug containing the Solarcaine formula - lidocaine alone or in combination with aloe vera - marketed in the U.S. prior to the Dec. 4, 1975 cut-off date for exemption from OTC review with indications for "severe sunburn," "severe sunburn pain" or to "heal sun damaged skin." FDA also warned that it is "seriously concerned" with the way the product is marketed since severe sunburn and sunburn pain are "potential health hazards" that require physician attention. The product has been promoted in print ads as a treatment for a "preschool child with a severe sunburn over most of the child's body," according to FDA. "This promotion and other statements and representations in the labeling present a potential health hazard," the agency maintains, since the conditions the ad claims that the product treats "are not amenable to self diagnosis and treatment by the laity." The reg letter also charges that Solarcaine Pure Aloe Severe Sunburn Relief Spray is in "serious violation" of the FD&C Act section 502(a) for labeling that is mis-branded and "false and misleading." The product's warning label is misleading and "contradictory" in that it says to consult a physician but offers the product for self treatment. Further, the label is misleading in that it includes "pure aloe" in the name and "features the term `aloe' in juxtaposition with and in larger type than the only declared active ingredient, lidocaine, and otherwise features aloe vera in a manner that creates an impression of greater value...while at the same time failing to declare 'aloe vera gel' as an active ingredient," FDA said. The agency also charges that the product is a drug, lidocaine topical aerosol, which is listed in the United States Pharmacopeia, and should therefore be required to state the concentration of lidocaine present. In addition, the product does not carry adequate directions for use and is an unapproved new drug for the conditions it claims to treat. The letter, from Office of Compliance Director Daniel Michels to Plough Personal Care Group President Michael Pietrangelo, gave the company 10 days to respond. Plough met with the agency on Nov. 22, FDA said.

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