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In Brief: Sodium labeling for mouthwashes

This article was originally published in The Rose Sheet

Executive Summary

Sodium labeling for mouthwashes: FDA is seeking comments on whether sodium-content labeling should be required for toothpastes, mouthwashes and mouth rinses, the agency announced in a final rule published in the April 22 Federal Register. The rule, which requires that OTC drugs intended for oral ingestion containing 5 mg or more sodium per dose disclose the sodium content on labeling, initially included these products, but dropped them pending further data collection. Also under the reg, products with a maximum daily dose containing over 140 mg sodium must bear the warning "Do not use this product if you are on a sodium-restricted diet unless directed by a doctor." Effective April 22, 1997, the rule additionally sets criteria for the use of the terms "sodium free," "very low sodium" and "low sodium"...

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