Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record

The proposed regulation intends to establish conditions in which antiseptic products are safe and effective to use with water. It requires (within 12 months) manufacturers to reformulate and relabel soaps, discontinue products, relabel as cosmetic soap or health care antiseptic, or conduct studies to show effectiveness.