Hand Sanitizer Labels: Requirements You Need To Know

Hand Sanitizer Labels: Requirements You Need To Know

Efforts to stop the spread of coronavirus have led to an explosion in consumer use of hand sanitizer products. As a result, businesses across the spectrum (from large pharmaceutical and cosmetic manufacturers to small distilleries) are turning to hand sanitizer production to supplement their revenue. 

However, there’s more to manufacturing sanitizer than simply bottling some sticky isopropyl alcohol-based liquid. Hand sanitizers have to follow strict guidelines—set by the Food and Drug Administration—including label designs. It’s critical to make sure you’re adhering to hand sanitizer labeling requirements.

What Makes Hand Sanitizer Labeling Different from Soaps and Other Cleaning Products?

The FDA has a specific list of requirements that sanitizer products must meet to be labeled as hand sanitizer:

Hand sanitizer is not a substitute for washing with soap and water. It should only be used when hand washing isn’t possible.

– Sanitizer is a leave-on product that is not rinsed off after use.

– These products can be either a liquid or a wipe.

– Anything sold as hand sanitizer must contain a certain volume of recognized active ingredients. You can find an up-to-date list of what is considered an active ingredient here. You can also see the latest temporary policies enacted in reaction to the COVID-19 pandemic here.

Since hand sanitizer must contain active ingredients used as a treatment for an ailment, hand sanitizer is categorized as a drug. That means the relevant FDA guidelines follow the same labeling requirements as other OTC (over-the-counter) medicines, which include requirements that affect the language used on this labeling. These requirements include a Principal Display Panel (PDP) to identify the product, and a Drug Facts panel to describe the product, its uses, and problems that may arise from use and storage.

Hand Sanitizer Label Components

There are specific parts of hand sanitizer labeling that must comply with certain FDA requirements in order to ensure they are clearly and consistently displaying important information for consumers. 

Principal Display Panel (PDP)

The principal display panel is the part of the label that faces outward when customers are shopping for a product. The PDP must cover at least 40% of the front-facing side of the package on round containers, or an entire side on square and rectangular containers. There are three components that must be included on the PDP:

Statement of Identity

The “statement of identity” distinguishes the product and what it does. 

For example, “Hand Sanitizer” for the identity and “Kills 99.9% of Germs” for its purpose: these statements are listed separately from the product name.

Net Volume

The FDA requires the panel to list net volume of the product in milliliters (mL). You can also list the weight in ounces, but the metric volume of the container contents must be part of the PDP.

National Drug Code (NDC)

All pharmaceuticals—even non-prescription OTC medicines—must be issued a National Drug Code (NDC) before going on sale. This database lists every drug offered through commercial distribution in the United States, identifying each product using a three-part number. This number must be printed on the PDP.

Drug Facts Panel for Hand Sanitizer Labels

Like the nutrition facts panel on food products, the drug facts panel tells customers exactly what is contained inside (and what it does). Here is a list of hand sanitizer label requirements for this section of the label and some examples of information for each category:

Active Ingredients

Example content:Ethyl alcohol 72% – Antiseptic.” 

Alcohol content and the purpose it serves is an important piece of information.

 

Product Purpose

Example content:Hand sanitizer is intended to help reduce bacteria and viruses that can cause disease. For use when soap and water are not available.” 

The label must make clear that sanitizer is not a replacement for proper handwashing.

Product Warnings

Warnings should include scenarios in which the product should not be used and procedures for adverse events, side effects or previous medical conditions. Since most hand sanitizers use alcohols as their active ingredient, a warning about flammability will go here.

Example content: 

“Keep away from heat and flame.

For external use only.

Do not use

– in children under 2 years of age

– on open wounds.

Keep out of reach of children.”

Dosage and Usage Directions

Example content: “Directions: Place enough product on your hands to cover all surfaces. Rub hands together briskly until dry. To prevent swallowing, children under 6 years of age should be supervised when using this product.”

Storage and Other Information

Example content:

“Store between 15-43°C (59-110°F)”

      • Celsius is used first when mentioning temperature.

Inactive Ingredients

Example content:

“Water (Aqua), Glycerin, Tocopheryl Acetate.” In addition to the active ingredients, inactive ingredients must also be listed.

Manufacturer’s Name and Address

This may be the name and business address of the manufacturer, packer or distributor of the product.

Example content:
“Distributed by:
Label Customer, LLC
110 Main Street
Salem, OH 44460”

A “Questions?” or “Questions or Comments?” section is not required to meet FDA hand sanitizer label requirements, but it is a good manufacturing practice to help eliminate consumer confusion about the product. This section lets you add a contact number that customers can call if there is concern about how to use your product.

Protections Against Counterfeiting

While counterfeiting is an issue across the pharmaceutical industry, it’s a major problem for hand sanitizer in the wake of the COVID-19 pandemic. Due to CDC recommendations for preventing the spread of COVID-19, the demand for sanitizer has skyrocketed, bringing both legitimate and illegitimate producers into the industry. 

Unscrupulous sellers and manufacturers often substitute methanol, a poisonous alcohol, in place of approved ingredients. To counteract this, the FDA now has a web page to help consumers choose safe hand sanitizers and avoid counterfeits.

As a manufacturer, you can help prevent counterfeit sanitizer from mixing with your products by making your labels difficult to duplicate. This includes hidden images and tamper-proof labels, as well as randomized tracking numbers and barcodes printed on the label during production. By making your products easy to identify, counterfeit products can be removed from the shelves instead of resorting to recalling all products.

Choosing a Labeling Machine for Your Product Line

If you want to add unique information to each container to prevent counterfeiting, consider our The 3600pa Series Label Printer Applicator. The onboard computer can generate barcodes in over a dozen formats for label printing, and it has several text and graphics options. The 3600a Series comes with support for most types of communication, including RS 232, Ethernet, USB and wireless, allowing it to obtain serial numbers and other identifying information from the rest of your operations system.

Does your business normally produce alcoholic beverages? Our 360a-WR Wrap System is designed to handle a range of bottles. This way, you can use it to apply labels to hand sanitizer bottles, then switch back to your standard production once the demand for your regular products returns.

Of course, we have options for smaller scale production and smaller containers, as well. Our semi-automatic tabletop labeling system is perfect for round, pocket-sized bottles of sanitizer.

CTM Labeling Will Get You Up and Running with New Product Labels

If you’re setting up a new product line, like hand sanitizer amid the COVID-19 pandemic, contact CTM Labeling Systems. Our local distributors can work with you to set up a hand sanitizer labeling system that delivers the quality you need for your containers, whether you’re labeling shipping boxes, pharmaceutical bottles or anything in between.