What are the FDA Regulatory issues relating to Leave-On Antiseptic Products?
One question that folks will have relates to the choice of quat active ingredient, either benzalkonium chloride or benzethonium chloride, and recent issues relating to them. With regard to benzalkonium chloride or benzethonium chloride and the Agency, note that both quats are listed in the Antiseptic monograph as Category III for safety and efficacy. Category III for safety and efficacy means FDA did not have sufficient efficacy and safety information to list them as Category I for hand antisepsis. However, this category allows them to be marketed in products that fall within the monograph as long as the formulations conform to the percentage ranges in the monograph (Benzethonium = 0.1-0.2%; Benzalkonium = 0.1-0.13% – note this is hard to track in the monograph but we have confirmed it with FDA). Nobac Instant Hand Sanitizer is in compliance with 0.1% benzalkonium chloride.
