Nine Brands of Toxic Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol)
The US Food and Drug Administration determined that samples of hand sanitizers, Lavar Gel and CleanCare NoGerm, contain methanol (wood alcohol), a toxic substance when absorbed through the skin or ingested. Methanol should not be used as an ingredient in hand sanitizers due to its toxic effects.
- Lavar Gel contains 81 percent (v/v) methanol and no ethyl alcohol, and
- CleanCare No Germ contains 28 percent (v/v) methanol.
FDA warns consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol).
FDA has identified the following nine brands of hand sanitizers manufactured by Eskbiochem. These nine brands of hand sanitizers are being marketed based on OTC monograph.
- 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)
FDA advises consumers who have been exposed to hand sanitizer containing methanol to immediately seek 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.
FDA recommends consumers stop using these hand sanitizers and dispose of them immediately in appropriate hazardous waste containers. Do not flush or pour these products down the drain.
Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) issued a final rule, helping to ensure that hand sanitizers available over-the-counter (OTC) are safe and effective for those who rely on them.
The final rule establishes that certain active ingredients are not allowed to be used in over-the-counter (OTC) hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC (non-prescription) Drug Review.
This final action finalizes the 1994 tentative final monograph (TFM) for OTC consumer antiseptic rub drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM), as amended by the proposed rule published in the Federal Register (FR) of June 30, 2016 (2016 Consumer Antiseptic Rub proposed rule).
“Our action aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “In today’s final regulation we finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. We’ve also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers. We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data.”
The final rule is available in PDF below.
Last updated: 2020-06-23
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