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Posted August 13, 2020

FDA Warns Soluciones Cosmeticas for Hand Sanitizers That May Contain Toxic Ingredient

On August 4, 2020, the FDA issued a warning letter to Soluciones Cosmeticas, SA de CV which after FDA testing found samples of the company's BERSIH Antiseptic Alcohol 70% Topical Solution Hand Sanitizer and BERSIH HAND SANITIZER GEL Fragrance Free to contain methanol, a toxic ingredient.

BERSIH Antiseptic Alcohol 70% Topical Solution Hand Sanitizer is labeled to contain 70% ethanol by volume, but FDA laboratory testing showed that the product contained an average of 44% ethanol and 30% methanol. BERSIH HAND SANITIZER GEL Fragrance Free is labeled to contain 70% ethanol by volume, but FDA laboratory testing showed that the product contained 67% ethanol and 1.6% methanol. Because the active ingredient on each product's label is substituted partially or completely by a different ingredient, the FDA warned these products are adulterated. 

Methanol, sometimes called wood alcohol, is poisonous. Methanol exposure through the skin or by ingestion can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The agency warned that consumers who have been exposed to hand sanitizer containing methanol to "seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning." 

Hand sanitizer containing at least 60% ethyl alcohol (ethanol) is recommended by the CDC for disinfecting hands when soap and water are not available, and is generally considered safe when used as directed. See the CDC's website for more information about using hand sanitizer.

The FDA first warned consumers about the presence of methanol in certain Soluciones Cosmeticas products in July. Soluciones Cosmeticas recalled some of its hand sanitizer products ten days later. The agency is advising consumers to stop using products that may contain methanol and to dispose of them.

See related warnings:

Nine Hand Sanitizers May Contain Toxic Ingredient That Can Cause Serious Illness or Death

FDA Warns Five More Hand Sanitizers May Contain Toxic Ingredient

Forty-Six More Hand Sanitizers May Contain Toxic Ingredient, Ten More Recalled

Two More Hand Sanitizers That May Contain Toxic Ingredient Recalled

Four More Companies Recall Hand Sanitizers

FDA Warns Eskbiochem for Hand Sanitizers That May Contain Toxic Ingredient

Two More Companies Recall Potentially Toxic Hand Sanitizers

Command Brands Gel AntiBac Instant Hand Sanitizer Recalled

Gelbac T Antibacterial Handgel Recalled

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