Hand sanitizer. Germs are everywhere! They can get onto hands and items we touch during daily activities and make you sick. Cleaning hands at key times with soap and
water or hand sanitizer is one of the most important steps you can take to avoid
getting sick and spreading germs to those around you.
There are important differences between washing hands with soap and water
and cleaning them with hand sanitizer. For example, alcohol-based hand
sanitizers don’t kill ALL types of germs, such as a stomach bug called norovirus,
some parasites, and Clostridium difficile, which causes severe diarrhea. Hand
sanitizers also may not remove harmful chemicals, such as pesticides and
heavy metals like lead. Handwashing reduces the amounts of all types of germs,
pesticides, and metals on hands. Knowing when to clean your hands and which
method to use will give you the best chance of preventing sickness.
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Hand sanitizers are regulated in the USA by the Food and Drug Administration (FDA) as drugs. In 1994, the FDA published a document called the “Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products.” It is commonly known in the industry as the TFM. The document, though “tentative,” serves as a road map to testing requirements and covers all sorts of antimicrobials meant to be applied to skin, including hand sanitizers. FDA is interested in finalizing the monograph, but it is not expected to be finalized any time soon.
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Companies interested in marketing a hand sanitizer in the United States will benefit from becoming familiar with the FDA Tentative Final Monograph. Sections of the FDA Tentative Final Monograph follow, with excerpts hightlighted and discussed in further detail. Remember, the tables and sections discussed below come from the tentative final monograph, so there’s room to customize and streamline studies for submission to regulatory agencies.
Alcohol-based hand sanitizer is simple to use, convenient, and often easy to find. While there is a correct way to use to get the most benefit from it, what’s probably more important is knowing when using it may not be the best choice. Hand sanitizer can help kill microbes, but it isn’t effective on all germs and will do nothing for other substances that may be on your hands.
Laboratory studies from the Centers for Disease Control and Prevention show alcohol-based made from 60% ethanol and 70% isopropanol are able to inactivate viruses genetically related to COVID-19.1 Learn about COVID-19, including symptoms and how it’s diagnosed.