FDA Regulation, hand sanitizer
Feb 15 2022
FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product manufacturers, and international partners to address the coronavirus disease 2019 (COVID-19) pandemic.
One of the best ways 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, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.
There is currently no evidence that consumer antiseptic wash products (also known as antibacterial soaps) are any more effective at preventing illness than washing with plain soap and water. In fact, some data suggests that antibacterial ingredients could do more harm than good in the long-term and more research is needed.
Does FDA regulate all hand sanitizers?
Do hand sanitizers come with product information on their labeling?
Hand sanitizers are over-the-counter (OTC) drugs regulated by FDA.
Hand sanitizers that meet FDA’s OTC drug review conditions will include a “Drug Facts” panel with product information on the labeling. 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.
Do hand sanitizers have an expiration date?
Are they still effective after the expiration date?
OTC drug products generally must list an expiration date unless they have data showing that they are stable for more than 3 years and their labeling does not bear dosage limitations. FDA does not have information on the stability or effectiveness of drug products past their expiration date (See 21 CFR 211.137).
Hand sanitizer that was produced under FDA’s withdrawn temporary policies for hand sanitizer production and compounding may not have an expiration date listed because they are expected to be used during this public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 emergency.
Label and Ingredient
Hand sanitizers listed with FDA, or a company has listed product with FDA
FDA publishes product listing information provided by the companies that make the drug on the National Drug Code (NDC) Directory.
This listing does not mean the drug is approved by FDA.
Label of “alcohol” hand sanitizer
Hand sanitizers labeled as containing the term “alcohol,” used by itself, are expected to contain ethanol (also known as ethyl alcohol).
Only two alcohols are permitted as active ingredients in alcohol-based hand sanitizers – ethanol (ethyl alcohol) or isopropyl alcohol (isopropanol or 2-propanol). However, the term “alcohol,” used by itself, on hand sanitizer labels specifically refers to ethanol only.
Methanol and 1-propanol are not acceptable ingredients in hand sanitizer and can be toxic to humans.
There are no antiseptic drug products, including hand sanitizer, that are approved by FDA to prevent or treat COVID-19. 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.
What is the risk of using a hand sanitizer that contains methanol (wood alcohol)?
FDA is warning consumers and health care professionals about hand sanitizers that contain methanol, also known as wood alcohol, because it is a dangerous and toxic substance. Methanol can cause serious side effects when absorbed through the skin and can cause blindness or death when swallowed.
Most hand sanitizers found to contain methanol do not list it as an ingredient on the label (since it is not an acceptable ingredient in the product), so it’s important to check FDA’s list to see if the company or product is included.
Denaturants are added to alcohol to make it less appealing to ingest. Denatured alcohol is used in hand sanitizer to deter children from unintentional ingestion – the denatured alcohol makes the hand sanitizer taste bad so children will not want to continue once they have had a taste. There are a number of adverse events every year resulting from intentional or unintentional ingestion of hand sanitizer, which is a particular concern for young children.
For children under six years of age, hand sanitizer should be used with adult supervision. When used according to the directions on the Drug Facts Label, hand sanitizer is not dangerous for children.
Hand sanitizer is dangerous when ingested by children. Drinking only a small amount of hand sanitizer can cause alcohol poisoning in children. However, there is no need to be concerned if your children eat with or lick their hands after using hand sanitizer. It is also important to keep the product out of the eyes; FDA issued a Drug Safety Communication warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye.
Therefore, it is very important to store hand sanitizer out of reach and monitor children when they are using hand sanitizer.
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