SAFETY ASSESSMENT: BENZALKONIUM CHLORIDE AS SANITISING AGENT

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BENZALKONIUM CHLORIDE

Benzalkonium chloride or BAC is an antibacterial agent belonging to the quaternary ammonium compound group. It is widely used in the health care industry and cosmetic industry as an antimicrobial and cleansing agent. According to the Food and Drug Administration (FDA), 0.1-0.13% w/w BAC is considered safe and effective as an “antiseptic drug product”.55 BAC has also been recognized as safe and effective when incorporated into oral mouth rinses.56

BAC is also popularly used as a rinse-free hand sanitizer and for hand washing.57 Short-term and long-term clinical studies have shown that BAC incorporated in intranasal products is safe and well-tolerated. 58

Furthemore, BAC meets the performance criteria under the Tentative Final Monograph for Health Care Antiseptic Drug Products as an active component in rinse-free hand sanitizers. Sufficient evidence exists to support the usage of BAC as a Category I active ingredient in 1994. It was analyzed as a leave-on sanitizer at the Final Monograph for Healthcare Personnel Antiseptic Drug Products. 59

A study by Dyer et al concluded that a hand sanitizer with BAC as the main component was a safe and