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This article was originally published in The Tan Sheet

Executive Summary

ALCOHOL-CONTAINING MOUTHWASH CHILD-RESISTANT PACKAGING is being considered by the Consumer Product Safety Commission following the submission of a petition on the issue by 29 attorney generals in February. Noting that within the last five years, "there have been over 10,000 reported incidents of ingestions of mouthwash containing ethanol by children under six" and at least three deaths, the petition asked CPSC to establish "special packaging standards for mouthwashes containing more than 5% alcohol" ("The Tan Sheet" March 1, p. 11). CPSC said it will make a decision on the petition "within the next several months." CPSC said that it issues rulings on which products should employ child-resistant packaging based on risk assessments of that product. Child-resistant packaging for alcohol-containing mouthwashes is an issue that the commission was planning to take action on, but did not consider a priority until the petition was filed, CPSC indicated. A higher priority for CPSC has been to urge child-resistant packaging for OTC preparations containing the antidiarrheal ingredient loperamide. A regulation to require child-resistant closures on antidiarrheal products containing .045 mg loperamide was proposed by CPSC in an October 1992 Federal Register notice. Loperamide poisoning has been attributed to the deaths of 11 children under five worldwide. However, most of the deaths were not due to accidental ingestion, but rather to "intentional administration of loperamide to children" in foreign countries, CPSC said. The first loperamide-containing product on the U.S. market, Johnson & Johnson's Imodium A-D, has always been marketed with child-resistant closures. However, CPSC's 1992 proposal was in anticipation of future loperamide products hitting the market without the safety packaging. Rhone-Poulenc Rorer's Maalox Anti-Diarrheal, for instance, was launched since the proposal and is not packaged with safety closures. A final rule for OTC loperamide is expected to be published in the Federal Register within the next year. Other OTC preparations for which CPSC would like to require child-resistant packaging include lidocaine (the active ingredient in Upjohn's Mycitracin Plus Pain Reliever) and dibucaine (the active ingredient in Ciba Consumer's Nupercainal Pain Relief Cream and Nupercainal Hemorrhoidal and Anesthetic Ointment). Both are topical anesthetics. CPSC reported that it is aware of "nine lidocaine-related deaths and six dibucaine-related deaths." CPSC is in the midst of the rulemaking process to require child-safety packaging for products containing lidocaine and dibucaine. A proposed rule mandating child-proof caps was published in the Federal Register in July 1992. The importance of child-resistant packaging for ingredients such as lidocaine, dibucaine and loperamide was highlighted by CPSC Commissioner Jacqueline Jones-Smith at a March 16 press conference held by the National Poison Prevention Week Council. The event was scheduled to kick off National Poison Prevention Week on March 21-27.

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