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Most consumer antiseptics are sold in retail establishments like drug stores and grocery stores.
How are health care and consumer antiseptics being evaluated? FDA compares the risks and the benefits for active ingredients under specified conditions of their use to help determine whether that active ingredient is generally recognized as safe and effective (GRASE).
Since FDA’s 1994 evaluation of OTC antiseptics, many things have changed, including the frequency of use of some products, new technology that can detect low levels of antiseptics in the body, FDA’s safety standards, and scientific knowledge about the impact of widespread use.
FDA’s current effort is designed to ensure that the safety and effectiveness evaluations and determinations for active ingredients used in antiseptics are consistent, up-to-date, and appropriately reflect current scientific knowledge and increasing use patterns.
FDA proposed that data was needed from a standard battery of tests that is used to determine the safety of many drugs, including OTC antiseptics.

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