Janitorial & Sanitation Reference Library · Technical Reference

Hand Soaps and Hand Sanitizers

Hand soaps and sanitizers come as foam, gel, lotion and liquid, and fall into two regulatory groups: plain soaps that only clean, and antiseptic products that are regulated as over-the-counter drugs. This sheet explains the forms, the labels and the FDA rules that changed which antibacterial ingredients can be sold.

Ref JS-010521 CFR 310.545

Draft, open for review. Check every value against the governing standard and the manufacturer’s data before use.

What it is

Plain hand soap removes soil and germs by washing and rinsing. If it is a true soap and only claims to clean, it is regulated by the Consumer Product Safety Commission. If it is a synthetic detergent or makes cosmetic claims such as moisturizing, FDA regulates it as a cosmetic. Antibacterial soaps and hand sanitizers claim to kill germs, so FDA regulates them as over-the-counter drugs. They must carry a Drug Facts panel listing the active ingredient. In 2016 FDA ruled that triclosan, triclocarban and a number of other ingredients may no longer be used in consumer antiseptic washes. Those ingredients are listed in 21 CFR 310.545.

How to identify

Look for a Drug Facts panel. If it has one, it is an antiseptic drug product, and the active ingredient and percentage are listed at the top. If it only has an ingredient list, it is a plain or cosmetic soap. Hand sanitizer labels state the alcohol type (ethyl alcohol or isopropyl alcohol) or a non-alcohol active such as benzalkonium chloride.

Product forms

Form	Description	Pros	Watch for
Foam soap	Dispensed as foam from a foaming pump	Uses less product per wash, rinses fast	Needs a foaming dispenser and refill
Liquid or gel soap	Poured or pumped liquid	Works in bulk and cartridge dispensers	Bulk refilling can contaminate dispensers
Lotion soap	Thicker, with conditioning agents	Gentler on hands	Can clog some valves
Heavy-duty or pumice soap	Contains scrubbers or solvents	Grease and shop soils	Not for food areas
Alcohol sanitizer (gel, foam, liquid)	Leave-on, no rinse	Fast, no sink needed	Flammable; does not remove heavy soil
Alcohol-free sanitizer	Usually benzalkonium chloride	Not flammable	Different efficacy profile; check label

Key points

Soap and water is preferred when hands are visibly dirty or greasy. Sanitizer does not remove soil.
CDC advises using a sanitizer with at least 60% alcohol when soap and water are not available.
Sealed cartridge refills reduce the contamination risk that comes with topping off bulk soap dispensers.
Food plants often require soaps and sanitizers registered for food areas. Check the facility's program.
FDA has warned against sanitizers contaminated with methanol. Buy from known suppliers and check FDA notices.

Common mistakes

Selling a triclosan product, or old stock, for consumer hand washing.
Topping off a bulk soap dispenser without cleaning it.
Putting a gel refill in a foaming dispenser.
Using sanitizer in place of washing in a shop or food area with greasy or visible soil.

Governing standards: 21 CFR 310.545 (drug ingredients not generally recognized as safe and effective); FDA OTC drug labeling rules; CDC hand hygiene guidance.

Reference only. Verify against the current governing code or standard, the manufacturer's data and the project documents before use. Apps for Distributors disclaims liability arising from reliance on this reference.

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