To our Valued Distributors about Recent FDA Recalls of Methanol Based Hand Sanitizers
All Innovation-Line hand sanitizer products are FULLY COMPLIANT with FDA regulations and DO NOT CONTAIN methanol or 1-propanol as an active ingredient. Under a final rule issued by FDA on April 12, 2019, FDA ethanol, isopropyl alcohol and benzalkonium chloride are the only types of alcohol allowed as the active pharmaceutical ingredient (API) in topical antimicrobial drug products for over-the-counter human use (hand sanitizers). Innovation-Line can provide a Certificate of Analysis (COA) to confirm the purity of its products.
We are aware that FDA has recently identified several hand sanitizer products - primarily imported from Mexico - in which methanol (wood alcohol) was substituted as the active ingredient instead of ethanol, isopropyl alcohol or benzalkonium chloride. As methanol is a natural impurity in ethyl alcohol, trace amounts are normal and allowable by FDA if they do not exceed 630 parts per million. If the methanol content of a hand sanitizer exceeds 630 parts per million, FDA regards the products as adulterated (not compliant). Innovation Line hand sanitizer is NOT IMPORTED from Mexico and complies fully with all FDA limits and requirements.
For further information, please review the link below with the documents from the FDA and the Methanol Institute.