The short answer
Hand sanitizer is not a cosmetic in the U.S. — it is an over-the-counter drug. That means drug establishment registration, an NDC, drug listing and a Drug Facts label, and FDA tests imports for toxic methanol.
What exporters should watch for
💊 An OTC drug
Hand sanitizers and antiseptic hand rubs are OTC drugs. The factory must register with FDA as a drug establishment, get an NDC labeler code, list each product and name a U.S. Agent.
☠️ Methanol
In 2020–2021 FDA found many imported hand sanitizers containing methanol, which is toxic, and in 2021 placed all alcohol-based hand sanitizers from Mexico on an import alert. Test each batch for methanol and other impurities.
🧪 Formulation
Active ingredients and their strengths must follow FDA’s requirements for consumer antiseptic rubs. Products marketed as killing specific germs or protecting for hours need support for those claims.
🏷️ Drug Facts label
The label needs a Drug Facts panel with active ingredient, purpose, uses, warnings and directions, plus the NDC. Cosmetic-style labels are not enough.
Common reasons shipments are stopped
- Methanol or other toxic impurities
- Not registered or listed as an OTC drug
- No Drug Facts label or NDC
- Unsupported claims (e.g. “kills 99.99% for 24 hours”)
- Sold as a cosmetic instead of a drug
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Is hand sanitizer a cosmetic or a drug in the U.S.?
A drug. Because it is intended to reduce bacteria on the skin, hand sanitizer is an over-the-counter drug. The manufacturer needs FDA drug establishment registration, an NDC labeler code, drug listing and a Drug Facts label.
Why does FDA test imported hand sanitizer for methanol?
Because many imported hand sanitizers in 2020–2021 contained methanol, which can cause blindness or death if absorbed or swallowed. FDA warned about hundreds of products and placed alcohol-based hand sanitizers from Mexico on an import alert, so batch testing is essential.
Sources
- FDA — Is it a cosmetic, a drug, or both?
- FDA — Import Alerts by Publish Date
- News-Medical — FDA takes action on alcohol-based hand sanitizers from Mexico (Jan 2021)
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.