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How to Create FDA Approved Hand Sanitizer Labels

Large hand sanitizer bottle

The entire world is currently faced with a crisis that is COVID-19. We’ve noticed lots of customers rising to the occasion to make hand sanitizer, hand soaps, and other personal care products in response to the increased need for these items. Our quick turnaround time has allowed us to fulfill many of these orders, but we’d like to go an extra step and provide some helpful information regarding the FDA requirements for hand sanitizer labels.

What is Hand Sanitizer?

Hand sanitizer is a liquid or gel used to eliminate germs on the hands, used by both consumers and health care workers alike to rid their hands of infectious agents when soap and water are not readily available. You’ve seen it produced in many forms: an automatic dispenser on the wall, a pump bottle in the office, and even in tiny, glittery bottles strapped to backpacks.

The FDA defines hand sanitizer as a leave-on product intended to be used when soap and water are not available, and is not rinsed off with water after being applied. This term can be used to describe both rubs and wipes, though rubs seem to be the most common application for this term. 

The FDA also stipulates that the presence and volume of certain active ingredients determine whether or not a product can be classified as hand sanitizer. So far, the FDA has deemed a list of nearly 30 ingredients as ineligible for marketing as hand sanitizer. Currently, alcohol-based hand sanitizers containing at least 60% of alcohol are considered effective in removing bacteria from hands. 

Important! The FDA supports the CDC’s recommendation to use soap and water to wash your hands primarily; hand sanitizer is a suitable alternative when soap and water are not immediately available.

Hand sanitizer pump bottle

Guidelines in Place for Hand Sanitizer Production

In light of the current crisis, the FDA has issued a document that stipulates temporary guidelines they established regarding the production of hand sanitizer products. As of now, the FDA is giving leniency to companies not identified as drug manufacturers who are producing hand sanitizers for commercial use, provided specific ingredients are used and certain guidelines are followed. 

A selection of the temporary guidelines are briefly described below:

  • Only the following ingredients are used in the preparation of the product:
    • Either ethanol no less than 94.9% by volume, or isopropyl alcohol
    • Glycerin United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”)
    • Hydrogen peroxide
    • Sterile water (by using a process that meets requirements for Purified Water USP
  • The alcohol (ethanol) is denatured by the producer of the alcohol, or when the hand sanitizer itself is produced.
  • The hand sanitizer is manufactured according to the following formula as recommended by the World Health Organization:
    • Ethanol (80% volume/volume) in an aqueous solution, or isopropyl alcohol (75% volume/volume) in an aqueous solution
    • Glycerin (1.45% volume/volume)
    • Hydrogen peroxide (0.125% volume/volume)
    • Sterile distilled water or boiled cold water
    • The FDA indicates that no other active or inactive ingredients be added to this formula, such as scents or fragrances. Different ingredients may impact the quality and/or potency of the product. So keep that glitter exclusive to craft time.

Please note that the FDA and the CDC do not recommend making DIY hand sanitizer at home due to the risk of damaging your skin or creating an ineffective product. Please reference the FDA’s document for a complete list of requirements and other best practices. 

Hand Sanitizer Label Requirements

As with most products regulated by the FDA, hand sanitizer labels require a principal display panel on the front label or the front of the product, as well as a Drug Facts panel. 

Principal Display Panel

The principal display panel (PDP) must cover at least 40% of the front-facing side of the package, or an entire side if the package is rectangular. The PDP must include the following information:

  • Statement of identity
  • Net weight (in mL)

The statement of identity lets your consumers know what the product is and what it’s used for. In this case, your statement of identity will be hand sanitizer. The net weight indicates the amount of product within the container and should be indicated in mL.

Most companies also list their company name on the PDP as well for easy visibility. 

Hand sanitizer FDA approved front label

Drug Facts Panel

Because hand sanitizer products claim to kill bacteria, they are classified by the FDA as an over-the-counter drug and therefore must have a Drugs Facts panel. The following information must appear in the Drugs Fact panel, following the same order:

  • Active ingredient(s)
  • The purpose of the product
  • The uses of the product
  • Any specific warnings, including when the product should not be used, and/or if consumers should consult a doctor or pharmacist before using
  • Dosage instructions or usage directions, i.e. when, how, and how often to use the product
  • Other information, i.e. how to store the product
  • Inactive ingredients

Be sure to check the FDA website for more specific information regarding the labeling of OTC drugs.

Manufacturer’s Name and Address

Give the name and business address of the distributor, packer, or manufacturer of your product on the information panel as well. 

If you manufacture and package the hand sanitizer product yourself, list your company’s name and business address. If you partner with a separate manufacturer, packer, or distributor, you’ll need to list their company name and address. Either way, providing additional information like a phone number, email address, or another method of contact may be beneficial for your consumers if they have questions about the product.

Hand Sanitizer Label Design

Whether you are mass-producing hand sanitizer or creating a few small batches for your local charity or community, you will need an FDA-approved label on your product. The requirements are simple enough that you could design the labels yourself using a program like Canva, but you may want to enlist the help of a graphic designer or check out the designers on freelance websites to ensure that your label meets requirements.

Best Label Materials for Hand Sanitizers

Since hand sanitizer products will be handled frequently, it’s best to choose a label material that is both waterproof and oil-resistant so that the label will stay looking fresh for the lifespan of the product. 

Any materials made of plastic or vinyl will be well suited for the job. We’ve noticed lots of customers opt for our clear materials–Clear Plastic and Ultra Clear Plastic. Clear label materials, while being waterproof and oil-resistant, also provide the opportunity for cool double-sided printing effects, as demonstrated on the water bottle label below.

Ever Dew water bottle with clear label

You can also use standard White Plastic or White Vinyl to create your labels, or up the ante by using Metallic Plastic or Hologram Plastic. No matter what you choose, we’ve got you covered!

Get Started

The need for hand sanitizers is great, so there’s not a moment to lose. If you have any questions regarding hand sanitizer labels, don’t hesitate to contact the Experience Team by either phone or Live Chat! Our team is still hard at work, ready to serve your business with the same level of care and excellence we’ve always had.

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