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Sanitizer Q&A

Q. Is hand sanitizer effective against COVID-19? A. 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% alcohol.

Q. Where can I buy hand sanitizer? If I can’t find it in the store, can I make my own? A. Many retail stores and pharmacies sell hand sanitizers. However, we understand that many stores have run out of hand sanitizers and they may be difficult to find. To help increase the availability of hand sanitizers, FDA has issued guidance for the temporary preparation of alcohol-based hand sanitizers by some companies and pharmacies during the public health emergency posed by COVID-19. See Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry1, the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency2, and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)3.

FDA recommends that consumers do not make their own hand sanitizer. If made incorrectly, hand sanitizer can be ineffective, and there have been reports of skin burns from homemade hand sanitizer. The agency lacks verifiable information on the methods being used to prepare hand sanitizer at home and whether they are safe for use on human skin.

Q. Is the FDA taking measures to increase the supply of hand sanitizers?A. Yes. FDA has recently developed multiple guidance documents for the temporary preparation of hand sanitizers by pharmacies and other companies during the public health emergency posed by COVID-19. The guidance documents describe circumstances under which the agency does not intend to take action when these companies prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency. FDA has also issued guidance for the temporary manufacture of alcohol by alcohol producers to use as the active ingredient in hand sanitizer products1,2,3.

Q. What do I do if I get a rash or other reaction to hand sanitizer?A. Call your doctor if you experience a serious reaction to hand sanitizer. FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:1,2,3.

  • Complete and submit the report online ; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Q. Many surface cleaners and disinfectants say they can be used against SARS-CoV-2. What does this mean? Can I use these products on my hands or body to prevent or treat the virus?A. Always follow the instructions on household cleaners. Do not use disinfectant sprays or wipes on your skin because they may cause skin and eye irritation. Disinfectant sprays or wipes are not intended for use on humans or animals. Disinfectant sprays or wipes are intended for use on hard, non-porous surfaces.

View the current list of products that meet EPA’s criteria for use against SARS-CoV-2, the cause of COVID-19. See Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions for more information.

Q. If I add alcohol to non-alcohol hand sanitizer, will this be better to prevent COVID-19?A. No. Addition of alcohol to an existing non-alcohol hand sanitizer is unlikely to result in an effective product. FDA has also issued guidance for the temporary preparation of certain alcohol-based hand sanitizer products by firms during the COVID-19 public health emergency. These temporary policies do not extend to non-alcohol based products at this time.

Q. Does the FDA regulate all hand sanitizers? Do hand sanitizers come with product information on their labeling?A. Hand sanitizers are over-the-counter (OTC) drugs regulated by FDA.

Hand sanitizers that meet FDA’s OTC drug review conditions or that are manufactured under the conditions in FDA’s temporary policy will include a “Drug Facts” label similar to the ones found at the end of the guidance: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Consumers should assure they are following the warnings and precautions described on this label, particularly regarding use in children. The Drug Facts label will also describe the ingredients in the product.

To address the supply shortage of hand sanitizers, FDA has recently developed multiple guidance documents for the temporary preparation of hand sanitizers by pharmacies and other companies during the public health emergency posed by COVID-19. The guidance documents describe circumstances under which the agency does not intend to take action when these companies prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency.

Q. Do hand sanitizers have an expiration date? Are they still effective after the expiration date?A. OTC drug products generally must list an expiration date unless they have data showing that they are stable for more than 3 years. FDA does not have information on the stability or effectiveness of drug products past their expiration date (See 21 CFR 211.137 ). Hand sanitizer produced under the temporary policies for hand sanitizer production and compounding may not have an expiration date listed because they are expected to be used during this public health emergency1,2,3.

Guidances referenced in QAs:

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

Show Me the Science – When & How to Use Hand Sanitizer in Community Settings Español (Spanish)

Note: For hand hygiene guidance in healthcare settings, please visit the Clean Hands Count webpage. CDC recommends washing hands with soap and water whenever possible because handwashing reduces the amounts of all types of germs and chemicals on hands. But if soap and water are not available, using a hand sanitizer with at least 60% alcohol can help you avoid getting sick and spreading germs to others. The guidance for effective handwashing and use of hand sanitizer in community settings was developed based on data from a number of studies. Alcohol-based hand sanitizers can quickly reduce the number of microbes on hands in some situations, but sanitizers do not eliminate all types of germs.

Why? Soap and water are more effective than hand sanitizers at removing certain kinds of germs, like Cryptosporidium, norovirus, and Clostridium difficile 1-5 . Although alcohol-based hand sanitizers can inactivate many types of microbes very effectively when used correctly 1-15 , people may not use a large enough volume of the sanitizers or may wipe it off before it has dried 14.
Hand sanitizers may not be as effective when hands are visibly dirty or greasy.

Why? Many studies show that hand sanitizers work well in clinical settings like hospitals, where hands come into contact with germs but generally are not heavily soiled or greasy 16 . Some data also show that hand sanitizers may work well against certain types of germs on slightly soiled hands 17, <18. However, hands may become very greasy or soiled in community settings, such as after people handle food, play sports, work in the garden, or go camping or fishing. When hands are heavily soiled or greasy, hand sanitizers may not work well 3, 7, 16. Handwashing with soap and water is recommended in such circumstances. Hand sanitizers might not remove harmful chemicals, like pesticides and heavy metals, from hands.

Why? Although few studies have been conducted, hand sanitizers probably cannot remove or inactivate many types of harmful chemicals. In one study, people who reported using hand sanitizer to clean hands had increased levels of pesticides in their bodies 19. If hands have touched harmful chemicals, wash carefully with soap and water (or as directed by a poison control center). If soap and water are not available, use an alcohol-based hand sanitizer that contains at least 60% alcohol.

Why? Many studies have found that sanitizers with an alcohol concentration between 60–95% are more effective at killing germs than those with a lower alcohol concentration or non-alcohol-based hand sanitizers 16, 20. Hand sanitizers without 60-95% alcohol 1) may not work equally well for many types of germs; and 2) merely reduce the growth of germs rather than kill them outright. When using hand sanitizer, apply the product to the palm of one hand (read the label to learn the correct amount) and rub the product all over the surfaces of your hands until your hands are dry.

Why? The steps for hand sanitizer use are based on a simplified procedure recommended by CDC 21. Instructing people to cover all surfaces of both hands with hand sanitizer has been found to provide similar disinfection effectiveness as providing detailed steps for rubbing-in hand sanitizer 22 . Swallowing alcohol-based hand sanitizers can cause alcohol poisoning.

Why? Ethyl alcohol (ethanol)-based hand sanitizers are safe when used as directed, 23 but they can cause alcohol poisoning if a person swallows more than a couple of mouthfuls 24 .

From 2011 – 2015, U.S. poison control centers received nearly 85,000 calls about hand sanitizer exposures among children 25 . Children may be particularly likely to swallow hand sanitizers that are scented, brightly colored, or attractively packaged. Hand sanitizers should be stored out of the reach of young children and should be used with adult supervision. Child-resistant caps could also help reduce hand sanitizer-related poisonings among young children 24. Older children and adults might purposefully swallow hand sanitizers to become drunk 26.
https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html