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How to Create FDA-Approved Hand Sanitizer Labels

How to Create FDA-Approved Hand Sanitizer Labels

With the current pandemic, hand sanitizers are needed more than ever. From liquor distilleries to cosmetics, many different companies have started making them to satisfy market demand. It’s a smart business move, but it can become a liability if companies do not follow FDA regulations. Read about today’s standards for hand sanitizers and how to create FDA-approved hand sanitizer labels.

Active Ingredients

The FDA regulates hand sanitizers so they truly work as antimicrobials. Therefore, your label must have a section that shows ethyl alcohol as the active ingredient and its percentage written as v/v%. They state that it should be 60% or more to stop the spread of germs and illnesses.


As with most FDA regulations on labels, you must include a section that shows what the hand sanitizer is used for. They stress the importance of stating that it “slows” the spread of germs or that it kills “most” germs, because hand sanitizer only kills 99.9% of germs. They also recommend adding “to be used when soap and water is not available” since that is still the most effective way to kill germs.


Every hand sanitizer label must have the following statements in the warning section: keep out of reach of children, for external use only, flammable or keep away from fire or flame, keep away from eyes, and wash eyes out with water if affected. It should also state what to do when using the product and to call a doctor if a rash appears and lasts.

Inactive Ingredients

When you’re learning how to create FDA-approved hand sanitizer labels you must also consider the inactive ingredients and list them. Some people may be allergic to specific ingredients or things that were added like aloe vera. Also, be sure to put an expiration date if any of the inactive ingredients have one. The FDA does not make hand sanitizer companies put expiration dates on generic sanitizers since they are often used so quickly. This is also why it is important to be printing labels of the best quality. A good digital label printer will be able to print labels with high-quality inks that will not deteriorate so easily from the label. This ensures that the important information remains intact and visible on the label.

Hand Sanitizer Labels