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Executive Summary

OTC GLYCERIN/ALCOHOL COMBO FOR PREVENTION AND TREATMENT OF SWIMMER's EAR will be placed in Category III in the OTC Products monograph, OTC Div. Director Gilbertson told Commerce Drug in a recent "feedback" letter. Gilbertson said that data submitted by the firm was insufficient to support the indication for its Auro-Dri otic product, and added that the division "intends to recommend to the Commissioner that the agency classify 5% anhydrous glycerin in 95% isopropyl alcohol in Category III for "'the prevention of swimmer's ear and treatment of water-clogged ears.'" Noting that the claims of prevention of swimmer's ear and treatment of water-clogged ears were not considered by the OTC Otic Products Panel, Gilbertson said "that final monograph will deal only with earwax removal aids." However, the FDAer said the agency "will publish a separate proposed rule to amend the final monograph in a future Federal Register" in order to obtain public comment on whether the claims should be added to the monograph. Gilbertson told the company that the clinical data submitted indicated that the product "was successful in drying more than 50% of the water in the ears of 42 out of 49 patients within a five minute period." He noted, however, that "the data provided do not address the question of the effectiveness in preventing swimmer's ear, because the data did not show prevention or a reduction in the incidence of swimmer's ear in a susceptible target population." In addition, Gilbertson said that although the firm claims Auro-Dri is a combination product, "the data did not show the effectiveness of each ingredient alone." Stating that each ingredient must be tested alone and in combination if therapeutic claims are made for both ingredients, Gilbertson said "if glycerin functions only as an inactive ingredient, additional testing would not be required for this ingredient."

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