The American Cleaning Institute (ACI)

Topical Antiseptics: Hand Sanitizers and Antibacterial Soaps

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health care provider using hand sanitizer

ACI is leading multi-year multi-million-dollar efforts to address FDA’s safety and efficacy data requirements in the final OTC Topical Antiseptic Monographs for Health Care, Consumer Wash and Consumer Rub products, in order to preserve and protect the marketplace for these products. 

ACI leads Interested Party Groups (IPGs) who fund, plan and direct the testing of antiseptic active ingredients to fill FDA’s Monograph data requirements.  ACI also serves as the point-of-contact for the IPGs in discussions with FDA to develop and approve study designs and protocols.

FDA OTC Monograph Requirements for Active Ingredients

Active Ingredients & Their Eligible Uses

Active Ingredients & Their Eligible Uses Consumer Hand Washes Health Care Consumer Hand Rubs
Patient Preoperative Skin Prep / Pre-Injection Skin Preparation Health Care Personnel Hand Washes Health Care Personnel Hand Rubs Surgical Hand Scrubs Surgical Hand Rubs
Ethanol (EtOH)*      
Benzalkonium chloride (BAC)*  
Benzethonium chloride (BZT)      
Chloroxylenol (PCMX)*      
Povidone-iodine (PVP-I)        
Isopropyl alcohol (IPA)      
* Active ingredients ACI is supporting.

FDA Assessment of Safety Data Gaps

Active Ingredient Human Pharmaco-kinetic (MUsT) Animal Pharmaco-kinetic Oral Carcino-genicity Dermal Carcino-genicity Reproductive Toxicity (DART) Potential Hormonal Effects Resistance Potential
Ethanol (EtOH)*
Benzalkonium chloride (BAC)*          
Benzethonium chloride (BZT)      
Chloroxylenol (PCMX)*      
Povidone-iodine (PVP-I)    
Isopropyl alcohol (IPA)  
= incomplete data;  = available data sufficient to make a GRAS/GRAE determination; Empty cell = no data available.
* Active ingredients ACI is supporting.

FDA Assessment of Effectiveness Data Gaps

Consumer Hand Wash Antiseptics
FDA: requires data from clinical outcome studies and surrogate endpoint studies (in vitro – Time Kill)


Consumer Hand Rub & Healthcare Antiseptics
FDA: requires data from surrogate endpoints (in vivo – bacterial log reduction; in vitro – Time Kill and MIC-MBC)

Research

Impact of benzalkonium chloride, benzethonium chloride and chloroxylenol on bacterial antimicrobial resistance
Journal of Applied Microbiology | December 2022
The use of products containing benzalkonium chloride (BKC), benzethonium chloride (BZT) and chloroxylenol (CHO) has been viewed as a concern for potential development of decreased bacterial susceptibility to biocides and/or chemotherapeutic antibiotics. Findings indicate that most literature does not show a decreased susceptibility, or efficacy when using these three active ingredients.

Ecological Risk Analysis for Benzalkonium Chloride, Benzethonium Chloride, and Chloroxylenol in US Disinfecting and Sanitizing Products
Environmental Toxicology and Chemistry | November 2022
The use of three topical antiseptic compounds – benzalkonium chloride (BAC), benzethonium chloride (BZT) and chloroxylenol (PCMX) – has increased due to the phase-out of other antimicrobial ingredients in soaps and other disinfecting and sanitizing products. The study finds that those compounds are unlikely to have adverse impacts in the environment, under the triclosan replacement scenarios that were evaluated.

Environmental Risk Assessments for Topical Antiseptic Ingredients: Chloroxylenol
Society of Environmental Toxicology and Chemistry North America Annual Meeting | November 2019

Environmental Risk Assessments for Topical Antiseptic Ingredients: Benzalkonium Chloride
Society of Environmental Toxicology and Chemistry North America Annual Meeting | November 2019

Environmental Risk Assessments for Topical Antiseptic Ingredients: Benzethonium Chloride
Society of Environmental Toxicology and Chemistry North America Annual Meeting | November 2019

News

Resources

Participating Member Companies

Arxada
GOJO Industries, Inc.
Reckitt
BODE Chemie GimbH
Edgewell
Henkel Corporation
Colgate-Palmolive Company
Kao Specialties America LLC
SC Johnson Professional
Novo Nordisk
Stepan Company
Ecolab Inc.
Pilot Chemical Company
Thomas Swan & Company
Procter & Gamble