Clarification on dissolving solutions
This article was originally published in The Tan Sheet
Executive SummaryFDA clarifies that 0.13 percent to 0.5 percent aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form, are generally recognized as safe and effective and not misbranded as astringent drug products. In a March 6 1final rule amending the final monograph for OTC skin protectant astringents, the agency also describes how manufacturers should relabel products. The rule grants the request from a 1995 citizen petition to revise FDA's 1993 monograph by including aluminum sulfate-calcium acetate combinations in powders and tablets to prepare an aluminum acetate solution. Labels must state the amount of each active ingredient and that those amounts, when dissolved in the indicated amount of water, must produce a 0.13 to 0.5 percent aluminum acetate solution. The compliance deadline is August 2010, FDA says
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