Salicylic acid is the only OTC ingredient listed as safe and effective (Category I) in the final monographs for wart remover products and corn and callus removers published by FDA in the Aug. 14 Federal Register. The final rule for OTC wart removal products allows three forms of salicylic acid to be used as the active ingredient in wart products. One form okayed by FDA is salicylic acid 12-40% in a plaster vehicle, which the agency defined as "a fabric, plastic or other suitable backing material in which medication is incorporated for topical application." A second option is salicylic acid 5-17% in a collodion-like vehicle, defined as "a solution containing pyroxylin (nitrocellulose) in an appropriate nonaqueous solvent that leaves a transparent cohesive film when applied to the skin in a thin layer." The third acceptable form is salicylic acid 15% in a karaya gum/glycol plaster vehicle. OTC corn and callus products can contain salicylic acid 12-40% in a plaster vehicle or salicylic acid 12-17.6% in a collodion-like vehicle. Corn and wart removers that do not meet these ingredient specifications have one year from the date of the notices to reformulate. OTC wart remover products meeting monograph conditions are indicated "for removal of common or planar warts." Corn and callus removers are indicated either "for the removal of corns and calluses" or to "relieve pain by removing corns and calluses." The corn/callus final rule, for the most part, is little changed from the tentative final monograph published in February 1987 ("The Pink Sheet" Feb. 23, 1987, T&G-9). The wart final rule also contains few changes from the March 1987 TFM, which was reproposed from an earlier, 1982 version so that the corn/callus and wart rules were coordinated with each other. Both final monographs contain a new strengthened warning that wart and corn removers should not be used "on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation." Because wart and corn removal preparations can cause acute inflammation or ulceration in people with these conditions, the new warning drops the phrase "except under a physician's supervision," which was proposed in the tentative final monographs. Another change made to both monographs gives manufacturers the option to include directions for pre-soaking feet before treatment, which the agency says "may be helpful" but has not been definitively shown to aid wart or corn removal. For wart products, FDA also specified that karaya gum pads are acceptable as a plaster vehicle, and that products containing pyroxylin, volatile solvents, and a plasticizer meet the definition of "collodion-like" vehicle. Wart removal ingredients considered by the agency and rejected as Category II/III (not shown to be safe and effective) are acetic acid, glacial acetic acid, ascorbic acid, benzocaine, calcium pantothenate, camphor, castor oil, iodine, lactic acid, and menthol. Category II/III ingredients rejected from the corn/callus monograph are glacial acetic acid, allantoin, ascorbic acid, belladonna extract, chlorobutanol, diperodon hydrochloride, ichthammol, iodine, methylbenzethonium chloride, methyl salicylate, panthenol, phenoxyacetic acid, phenyl salicylate, vitamin A, and zinc chloride. The use of ascorbic acid as a corn and wart remover ingredient, though rejected by FDA in the two mongraphs, is defended in a July 31 submission to FDA by Hoffman-La Roche. Roche notes that it is "an interested party as a major supplier of bulk ascorbic acid to the various industries utilizing the same, including the OTC drug industry." While containing several descriptions of the ingredient's in vitro ability to "inactivate" viruses and bacteria, Roche's submission contains no information on use of the ingredient to remove warts, corns or calluses. Vergo cream, marketed by Daywell Laboratories of Fairfield, Conn., is one OTC wart remover that contains ascorbic acid as an active ingredient.
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