Safety and Effectiveness of Consumer Hand Sanitizers
What the FDA and CDC Say About Hand Sanitizer Safety
To ensure consumer safety, the U.S. Food and Drug Administration (FDA) has been evaluating the active ingredients used in over-the-counter (OTC) hand sanitizers. While the Centers for Disease Control and Prevention (CDC) recommends handwashing as the most effective method to remove germs, it acknowledges the value of hand sanitizers—especially alcohol-based products—as a suitable alternative when soap and water are unavailable.
The FDA has issued a final rule confirming that OTC consumer hand sanitizers (also known as topical antiseptic rubs) must contain only certain active ingredients deemed safe and effective for repeated use. This rule excludes outdated or unsupported ingredients, such as triclosan and triclocarban, ensuring that products reflect the latest scientific knowledge.
Approved Active Ingredients
Ongoing research continues into the safety and efficacy of three main active ingredients:
- Ethyl alcohol
- Isopropyl alcohol
- Benzalkonium chloride
Among these, ethyl alcohol (ethanol) remains the most widely accepted and commonly used. The CDC recommends hand sanitizers with at least 60% alcohol for effective germ-killing action.
The End of Temporary Guidelines
During the COVID-19 pandemic, the FDA introduced temporary policies to increase the availability of hand sanitizers. However, these temporary measures were withdrawn as of December 31, 2021. All hand sanitizer manufacturers must now comply with standard FDA regulations, ensuring that every product meets strict safety, quality, and labeling requirements.
Why Proper Application Matters
Even with a safe and effective formula, how you use hand sanitizer impacts its effectiveness. Recent findings show that many consumers don’t use enough products to cover all hand surfaces. To be effective, a sanitizer should be applied thoroughly, using at least 1 ml to ensure full coverage.
Understanding Limitations
It’s also important to note that alcohol-based sanitizers are not equally effective against all types of viruses. While they work well against many germs, they may be less effective against non-enveloped viruses, such as norovirus. In high-risk environments or during outbreaks, proper hand washing with soap and water remains the gold standard.
Safetec: Committed to Safety and Quality
At Safetec of America, we go beyond the minimum standards. Our facilities are FDA-regulated, OSHA-compliant, and GMP-certified and undergo regular audits to ensure we continue to meet the highest standards of quality and safety.
Our Fresh Scent Instant Hand Sanitizer is formulated with 66.5% ethyl alcohol, well above the CDC’s minimum recommendation. It kills 99.9% of common germs, helping you stay protected when hand washing isn’t an option.
We offer a range of sizes to suit every need—from single-use pouches to personal 2 oz. disc top bottles to bulk 64 oz. pump bottles—making it easy to keep hands clean whether you’re at home, at work, or on the go.
Try the Safetec Hand Sanitizer Challenge
Are you a distributor? Put our product to the test. Take the Hand Sanitizer Challenge and compare Safetec’s performance and quality with your current brand. Contact our sales team for more information at 1-800-456-7077 or salesteam@safetec.com
About Safetec of America
For over 30 years, Safetec has been a leading manufacturer of first aid, infection control, and over-the-counter products. Located in Buffalo, N.Y., all our products are manufactured and distributed by us in our state-of-the-art FDA regulated facilities.
We first entered the infection control industry with Red Z®, our flagship product, to aid in protecting against infection during the AIDS epidemic. Since then, we have expanded our manufacturing capabilities and offer five product lines of various products. www.safetec.com