Washing your hands is one of the most important things you can do to avoid getting sick and spreading germs to people around you.
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). If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol to reduce the number of germs on your hands. However, hand sanitizers do not eliminate all types of germs, are not as effective when hands are visibly dirty or greasy, and may not remove harmful chemicals.
Hand sanitizers are an easy, quick alternative when handwashing with plain soap and water isn’t convenient or possible. Hand sanitizers often have a form of alcohol, such as ethyl alcohol, as an active ingredient and are used as an antiseptic.
Millions of Americans use these products every day, sometimes several times daily, to help reduce bacteria on their hands. That’s one of the reasons the U.S. Food and Drug Administration (FDA) is working to help ensure that over-the-counter (OTC) hand sanitizers are safe and effective for regular use.
Recently, the FDA asked manufacturers of hand sanitizers for more information on three commonly used active ingredients in OTC hand sanitizers. Those ingredients — alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride — are used in approximately 97 percent of OTC hand sanitizers.
The FDA’s request for more data about these three ingredients doesn’t mean the agency believes these products are ineffective or unsafe, or that these products should be removed from the marketplace. Rather, the agency asked for more data to help assess whether these products are safe and effective for regular use.
FDA Final Rule on OTC Hand Sanitizers
The FDA recently issued a final rule on OTC hand sanitizers and will continue to review the three active ingredients commonly used in hand sanitizers. The FDA doesn’t expect any significant change on what products are available to consumers based on this rule.
In the final rule, the FDA also finds that 28 other active ingredients are not eligible for review under the OTC Drug Review for use in OTC hand sanitizers. Most products that include these 28 active ingredients have already been taken off the market.
Why the FDA Is Evaluating Data on These Ingredients
The FDA last systematically evaluated scientific data on a broad range of OTC antiseptics, including hand sanitizers, in 1994. Since then, many things have changed, including the frequency of use of some products, new technology that can detect low levels of antiseptics in the human body, and scientific knowledge about the impact of widespread use of antiseptics. The FDA’s current evaluation is designed to ensure that our determinations on the safety and effectiveness of active ingredients used in antiseptics are consistent, up-to-date, and appropriately reflect current scientific knowledge and increasing use patterns.
Hand sanitizers are meant to be used when soap and water aren’t available. Today, compared to just a few years ago, they are being used more frequently and by many more people — including young children, pregnant women, and nursing mothers. People are using them throughout the day — at home, in schools, at work, in the supermarket, in cars, and when traveling.
The FDA wants to make sure the benefits of hand sanitizers outweigh the risks. For example, in the last few years, we have learned that some active ingredients in these antiseptics can be absorbed through the skin. As people use hand sanitizers more often, we want to make sure that any absorption is minimal and not harmful. We also want to confirm these products work as intended.
As the CDC says, the best way to prevent the spread of infections and decrease the risk of getting sick is to regularly wash your hands with plain soap and water whenever possible. If soap and water are not accessible or available, an antiseptic product may be a suitable alternative. With simple good hygiene, you can protect yourself and your family from getting sick.
April 11, 2019