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HEALTH CARE ANTISEPTICS TFM INCLUDES FIVE CATEGORY I INGREDIENTS

This article was originally published in The Tan Sheet

Executive Summary

HEALTH CARE ANTISEPTICS TFM INCLUDES FIVE CATEGORY I INGREDIENTS alcohol 60-95%, iodine tincture USP, iodine topical solution USP, povidone-iodine 5-10%, and isopropyl alcohol 70- 91.3%. However, only two ingredients alcohol 60-95% and povidone- iodine 5-10% -- are considered Category I (safe and effective) for all three health care antiseptic indications: patient preoperative skin preparation; antiseptic handwash or health care personnel handwash; and surgical hand scrub. The tentative final monograph for topical health care antiseptic drug products appears in the June 17 Federal Register.

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