OTC SKIN PROTECTANTS: WITCH HAZEL, ALUMINUM SULFATE, ALUMINUM ACETATE

OTC SKIN PROTECTANTS: WITCH HAZEL, ALUMINUM SULFATE, ALUMINUM ACETATE are the only ingredients allowed under the final monograph for OTC skin protectant astringent drugs, which was published in the Oct. 21 Federal Register. The effective date of the final monograph is Oct. 21, 1994. Hamamelis water (witch hazel), aluminum sulfate 46% to 63%, and aluminum acetate .13% to .5% were also the only ingredients to be listed as Category I (safe and effective) ingredients in an April 1989 notice of proposed rulemaking that amended the skin protectant tentative final monograph to include astringents. The skin protectant TFM originally was published in February 1983. The final rule declares ferric subsulfate (Monsel's solution) nonmonograph, stating that there are insufficient data on the ingredient to determine that it is safe and effective. FDA noted that it received one comment in support of OTC and professional use of ferric subsulfate solution, but found that the majority of the information provided was from professional use of the ingredient. "None of the data provided suggest that a product containing ferric subsulfate as an astringent/hemostatic agent has ever been used or could be safely used by consumers," the monograph states. All of the other ingredients considered under the skin protectant astringents rulemaking were categorized as nonmonograph under a May 10 "negative" final rule removing 415 Category II (not safe and effective) and Category III (data insufficient to permit classification) ingredients from seven OTC monographs ("The Tan Sheet" May 17, p. 3). As in the TFM, the final monograph limits indications for witch hazel to: "'For relief of minor skin irritations due to' (select one or more of the following: 'insect bites,' 'minor cuts,' or 'minor scrapes')." The agency said it received one comment requesting that it reconsider several other indications not included in the TFM, including "for use as an astringent for the treatment of bruises, contusions, and sprains" and "for relieving muscular pains." FDA noted, however, that no new data had been submitted to support these indications. Indications for aluminum acetate and aluminum sulfate listed in the final monograph also are identical to those stated in the TFM. Aluminum acetate is intended: "'For temporary relief of minor skin irritations due to' (select one or more of the following: 'poison ivy,' 'poison oak,' 'poison sumac,' 'insect bites,' 'athlete's foot,' or "rashes caused by soaps, detergents, cosmetics, or jewelry')." The indication for aluminum sulfate is: "'Stops bleeding caused by minor surface cuts and abrasions as may occur during shaving.'" The final monograph also outlines warning statements that are required on the labels of OTC products formulated with witch hazel, aluminum acetate or aluminum sulfate. For example, products containing witch hazel must state, "'For external use only. Avoid contact with eyes,'" while OTCs formulated with aluminum acetate must bear the warning, "'If condition worsens or symptoms persist for more than seven days, discontinue use of the product and consult a' (select one of the following: 'physician' or 'doctor')." Labeling for OTC products containing aluminum sulfate must state, "'Do not cover compress or wet dressing with plastic to prevent evaporation,'" according to the monograph.