FDA Advisory Regarding Hand Sanitizer

The Operational Services Division is sharing this information to help prevent exposure to a potential health risk associated with the use of certain hand sanitizers manufactured in Mexico.

The U.S. Food and Drug Administration (FDA) recently issued an advisory to consumers regarding hand sanitizers manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol, a substance that may be toxic when absorbed through the skin or ingested. Methanol is not an acceptable ingredient for hand sanitizers and it should not be used due to its toxic effects.

The FDA further advised that consumers should not use the following products manufactured by Eskbiochem:

• All-Clean Hand Sanitizer (NDC: 74589-002-01)
• Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
• Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
• The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
• CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
• CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
• Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

To date, FDA is not aware of any reports of adverse events associated with these hand sanitizer products. Samples of these products that were tested by the FDA indicated the presence of methanol ranged from 81% to 28% and the Lavar gel contained no ethyl alcohol.

Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.