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Alcohol-Based Hand Sanitizer Formulation Matters for Safety and Efficacy

David Macinga

5/1/2020


By David R. Macinga, Ph.D.


Product Development & Regulatory Affairs Vice President, GOJO Industries

During a public health emergency like this, when hand hygiene is a primary tool in keeping the public healthy, our first priority is getting safe and effective hand hygiene products to those who need them most. This includes hand sanitizer.

As the inventor of PURELL® hand sanitizer and the category leader in this space, we recognize how critical proper formulation and manufacturing are to safety and efficacy of these products. We believe it’s important for the public to understand this, too.

Hand sanitizer is regulated by the FDA as an over-the-counter drug, and there are robust regulations around its ingredients, manufacture and marketing to protect public health and ensure the safety of those manufacturing them. This includes clear direction around the grade of the alcohol used in these products, and the inclusion of denaturants, which are included in hand sanitizers to prevent ingestion. Recently, the FDA provided guidance to several fuel ethanol companies that their products do not meet these safety standards and has also reinforced the need to use a denaturant in hand sanitizer formulations to prevent ingestion.

We support the FDA guidance because product formulation of an alcohol-based hand sanitizer matters for both efficacy and safety. For 30 years – since we created the first PURELL® Hand Sanitizer in 1988 – we have carefully formulated and tested our proprietary hand sanitizers to kill the most germs, be gentle on skin, have a great user experience, and be as safe as possible.

We also adhere to the highest standards of product formulation and production. We only source from suppliers who offer the highest quality ethyl alcohol, suitable for OTC drug products. We conduct rigorous quality testing of both the alcohol and the finished PURELL® Hand Sanitizer to ensure it meets FDA drug product quality requirements. In addition, GOJO has always included a denaturant in our PURELL® Alcohol-Based Hand Sanitizer to inhibit misuse.

As a science-based company, we are committed to delivering on our GOJO Purpose – Saving Lives and Making Life Better through Well-Being Solutions – and the call is especially urgent during this public health crisis.

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