Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics

One of the most common classification errors foreign manufacturers make is assuming that hand sanitizers, antiseptic hand washes, and antibacterial soaps are cosmetics. In the United States, these products are classified as OTC drugs because they make claims to kill germs, reduce bacteria, or prevent infection — all of which are drug claims under the FD&C Act. A hand sanitizer that claims to 'kill 99.9% of germs' is a drug. An antibacterial soap that claims to 'reduce bacteria' is a drug. An antiseptic wound wash that claims to 'prevent infection' is a drug. This classification triggers the full spectrum of FDA drug requirements: drug establishment registration, NDC Labeler Code, drug product listing, Drug Facts panel labeling, and compliance with the applicable OTC drug monograph for antiseptic products.

The antiseptic monograph framework

Hand sanitizers and antiseptic products fall under the FDA's OTC drug monograph for topical antiseptic products. Consumer antiseptic hand rubs (hand sanitizers applied without water) and consumer antiseptic washes (antibacterial soaps used with water) are the two primary categories relevant to foreign manufacturers. The FDA's 2019 final rule for consumer antiseptic hand rubs determined that ethanol (60-95%), isopropyl alcohol (70-91.3%), and benzalkonium chloride are eligible for further review under the GRASE (Generally Recognized as Safe and Effective) framework, while other antiseptic active ingredients have been determined to be not GRASE for consumer hand rub use. For consumer antiseptic washes, the FDA's 2016 final rule determined that 19 previously marketed active ingredients — including triclosan and triclocarban — are not GRASE, effectively removing them from the market.

Registration and listing requirements

Foreign manufacturers of hand sanitizers and antiseptic products must register their establishments with the FDA under 21 CFR Part 207, obtain an NDC Labeler Code, and list each product through eDRLS in SPL format. These requirements are identical to those for any other OTC drug manufacturer. The establishment registration must be renewed annually between October 1 and December 31, and the manufacturer must pay applicable GDUFA and OMUFA fees. A US Agent must be designated as part of the registration. The product listing must include the active ingredient(s) and their concentration, the dosage form, the product labeling, and the NDC number.

Labeling and Drug Facts requirements

Hand sanitizer and antiseptic product labels must carry a Drug Facts panel in accordance with 21 CFR 201.66. The Drug Facts panel must identify the active ingredient (such as 'Ethyl Alcohol 70%'), its purpose ('Antiseptic'), the product's uses ('For hand sanitizing to decrease bacteria on the skin'), required warnings (including the warning to keep out of reach of children and the flammability warning for alcohol-based products), directions for use, and inactive ingredients in alphabetical order. The label must also include the manufacturer or distributor name and address, the NDC number, and the net contents. Products that do not carry a compliant Drug Facts panel are misbranded and will be refused entry at US ports.

Quality and safety concerns

The FDA significantly increased its scrutiny of hand sanitizer quality during and after the COVID-19 pandemic, when a surge in global production led to products containing methanol (a toxic wood alcohol that can cause blindness, organ damage, and death), products with sub-potent levels of ethanol or isopropanol (insufficient to provide antiseptic efficacy), and products contaminated with benzene and other impurities. The FDA issued numerous Warning Letters, import alerts, and product recalls for non-compliant hand sanitizers, and maintains an updated list of hand sanitizers consumers should not use. Foreign manufacturers must ensure their products are manufactured under CGMP conditions, use pharmaceutical-grade alcohol, and are tested for potency, purity, and the absence of toxic contaminants.

How FDABridge handles antiseptic product registration

FDABridge provides drug establishment registration, NDC Labeler Code acquisition, and drug product listing for foreign manufacturers of hand sanitizers, antiseptic washes, and related OTC antiseptic products. We handle the SPL formatting and electronic submission and ensure your Drug Facts labeling meets FDA requirements. Visit fdabridge.com/drug to see our drug registration services or fdabridge.com/contact to discuss your antiseptic product compliance.