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) products, manufacturers, exporters and importers must be registered as Drug Establishments with the U.S. Food and Drug Administration (U.S. FDA).
Such registration requires the DUNS Number of each establishment (manufacturer, exporter, importer). The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
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 National Drug Code (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).