Cardiovascular Associates Limited

FDA’s Response to Non-Alcohol-Based Hand Sanitizer

Is it ok to use non-alcohol-based hand sanitizer instead of alcohol-based hand sanitizer? Is it ok to use hand sanitizer with benzalkonium chloride instead of alcohol-based hand sanitizer? Is non-alcohol-based hand sanitizer effective against COVID-19?

There are currently no drugs, including hand sanitizer, approved by FDA to prevent or treat COVID-19. The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the Centers for Disease Control and Prevention (CDC). Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% ethanol.

While they are not alcohol-based, and thus not recommended by CDC, there are some hand sanitizer products containing benzalkonium chloride as an active ingredient that may be legally marketed if they meet the requirements for marketing under section 505G of the Food, Drug, and Cosmetic Act. However, as noted above, there are no hand sanitizers, including those containing benzalkonium chloride, that are legally marketed specifically for the prevention or treatment of COVID-19. Hand sanitizers using active ingredients other than alcohol (ethanol), isopropyl alcohol, or benzalkonium chloride are not legally marketed, and FDA recommends that consumers avoid their use.

Hand sanitizer prepared under FDA’s temporary policies during the COVID-19 public health emergency, as outlined in the guidances, cover only alcohol-based (ethanol and isopropyl alcohol) hand sanitizer. FDA’s temporary policies do not cover the use of other active or inactive ingredients not otherwise mentioned in the guidance for use in hand sanitizer, including benzalkonium chloride.

Source: https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19