FDA is aware of significant supply disruptions for alcohol-based hand sanitizers, and provided guidance to help boost production.
If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol).
Because hand sanitizers are considered over-the-counter (OTC) drug products, manufacturers, exporters, and importers must be registered as Drug Establishments with the FDA. Such registration requires the DUNS Number of each establishment. We also expect your company to provide an FDA compliant label, when contacting ITB HOLDINGS LLC.
How to find hand sanitizers listed with the FDA, or verify that a company has listed its product with the FDA?
For a list of all hand sanitizers, choose the proprietary name search, and search for the term “hand sanitizer”. Anyone can look up a drug product and download the information by searching its NDC or company name.
Reporting adverse events
FDA encourages consumers and health care professionals to report adverse events (everything from skin rashes to more serious complications) experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program. Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (Health Professional) or 3500B (Consumer/Patient):
■ Complete and submit the report online
■ Download and complete the form, then submit it via fax at 1-800-FDA-0178
Include as much information as you can about the product that caused the reaction, including the product name, the manufacturer, and the lot number (if available).