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Three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study.
April 11, 2019
By: Christine Esposito
Editor-in-Chief
The US Food and Drug Administration today issued a final rule on hand sanitizers available over-the-counter (OTC). The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review. The final rule also seeks to ensure that the agency’s safety and effectiveness evaluations and determinations for consumer antis...
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