Background: Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) issued guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID19). SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. Hand hygiene is an important part to control COVID-19. Washing hands often with soap and water for at least 20 seconds is essential, If soap and water are not readily available, then use an alcohol-based hand sanitizer.

1. Hand Sanitizer Use, Protection & Risk During the
COVID-19 Pandemic
Background:
Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug
Administration (FDA or Agency) issued guidance to communicate its policy for the
temporary compounding of certain alcohol-based hand sanitizer products. The virus has been
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease
2019” (COVID19). SARS-CoV-2 has demonstrated the capability to spread rapidly, leading
to significant impacts on healthcare systems and causing societal disruption. Hand hygiene is
an important part to control COVID-19. Washing hands often with soap and water for at least
20 seconds is essential, If soap and water are not readily available, then use an alcohol-based
hand sanitizer.
Active Ingredient:
Isopropyl alcohol and ethanol are two of the active ingredients currently being used for hand
sanitizers for use in reducing bacteria on the skin that potentially can cause disease or
decrease presence of bacteria on the skin. One safety precaution with alcohol-based hand
sanitizer is the use of denatured alcohol. This makes the sanitizer bitter-tasting and less
appealing to children. All active as well as other ingredient must be pharmacopeia grade. The
finished hand sanitizer product is compounded according to the recommendations of World

2. Health Organization (WHO): Ethanol formulated to 80%, v/v in an aqueous solution; or
Isopropyl Alcohol to 75%, v/v in an aqueous solution.
Impurities meet the interim limits listed in Table 1 below and no other potentially harmful
impurities are present other than those addressed in Table 1.
Impurity Interim Limits
Methanol NMT 630 ppm
Benzene NMT 2 ppm
Acetaldehyde NMT 50 ppm
Acetal (1,1-diethoxyethane) NMT 50 ppm
Sum of all other impurities NMT 300 ppm
Health Risk Due to Presence of Impurities:
 Methanol is metabolized to formaldehyde or formic acid in the body, which is more
toxic and harmful than those produced by the other alcohols. This can lead to a
dangerous build-up of acid in the bloodstream that damages organs and tissues,
particularly the optic nerve, causing vision impairment and blindness
 Acetaldehyde appears to be genotoxic, and potentially carcinogenic, when in direct
contact with tissues.
 Benzene causes harmful effects on the bone marrow and can cause a decrease in red
blood cells, can affect the immune system, increased risk of benzene related cancers.
 Acetal can cause skin inflammation and long exposer leads to cancer or mutations.
Ethanol produces acetate in the body and isopropanol produces acetone in the body.
Recently FDA detected some hand sanitizers brands that are labelled to contain ethanol but
that have tested positive for methanol contamination and also contains potentially fatal
ingredient.
Side Effects:
Hand sanitizers containing methanol, or wood alcohol, present a danger to individuals as the
substance can be toxic when absorbed through the skin or life-threatening if ingested,
according to the Food and Drug Administration (FDA). Recent reports of Skin allergy,
redness, dryness, cracks, and even blisters that cause itch or pain blindness. In some cases
hospitalizations and death following tainted hand sanitizer ingestion by both adults and
children highlight the potential dangers.
Signs and symptoms of methanol exposure may include nausea, vomiting, headache and
blurred vision. Serious adverse effects may include permanent blindness, seizures, coma,

3. permanent nervous system damage and death. Risks of health hazard is being increased
further amid the current COVID-19 pandemic since many people are using hand sanitizer
more frequently to try to protect against the devastating new coronavirus.
“Unfortunately, there are some companies taking advantage of the increased usage of hand
sanitizer during the coronavirus pandemic and putting lives at risk by selling products with
dangerous and unacceptable ingredients.”
Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims
that they can prevent the spread of viruses such as COVID-19, including claims that they can
provide prolonged protection. Some marketed as “FDA-approved” since there are no hand
sanitizers approved by FDA.
References:
i. Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer
Products During the Public Health Emergency Immediately in Effect Guidance for
Industry. U.S. Department of Health and Human Services Food and Drug
Administration Centre for Drug Evaluation and Research (CDER) March 2020
Updated June 1, 2020.
ii. World Health Organization. WHO GuidelinesonHandHygiene inHealthCare.FirstGlobal
PatientSafetyChallenge:CleanCare isSaferCare; WHO: Geneva, Switzerland, 2009.
iii. Health Canada. Two Deaths Linked to Ingestion of Hand Sanitizer Containing
Methanol. 2013.
iv. Qiao, J.S.; Guo, L.M. Six cases of methanol poisoning caused by skin absorption. J.
Henan Med. Univ. 1992, 27, 186–187.
v. Bolon, M.K. Hand hygiene: An update. Infect. Dis. Clin. North Am. 2016, 30, 591–
607.
vi. Centre for Health Protection. Guidelines for Hand Hygiene. 2017. Available
online: https://www.chp.gov.hk/files/pdf/guidelines_for_hand_hygiene.pdf .
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