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# Warning Letter on Unapproved Hand Sanitizers
- URL: https://www.fdaweb.com/warning-letter-on-unapproved-hand-sanitizers/
- Published: 2020-04-27T12:00:00.000Z
- Updated: 2026-09-14T16:12:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146654

FDA has sent Prefense LLC (Muscatine, IA) a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prefense-llc-605488-04232020?ref=fdaweb.com) for marketing unapproved hand sanitizers for preventing Covid-19\. The agency objected to numerous claims on the company’s Web site and social media platforms, such as “Sanitize your hands with Prefense nonalcoholic Hand & Skin sanitizer that can protect you for extended periods of time.” FDA says that the products are labeled with Amosilq (benzalkonium chloride/silica complex) as the active ingredient, which is not a proposed active ingredient in the rulemaking for topical antiseptic drug products. FDA told the company to correct the violation outlined in the letter.