The coronavirus continues to be a threat not only globally, but especially in the United States. Illinois has seen over 200,000 COVID-19 cases, with Cook, Lake, and DuPage counties ranking the highest. Wearing a face covering is required in all public spaces and hand sanitizer continues to be highly encouraged; in fact, any businesses require every patron to sanitize their hands upon entry as a precaution. The CDC first recommends using soap and water to wash your hands for a minimum of 20 seconds; however hand sanitizer is a suitable (and encouraged) alternative when soap and water are not immediately available.
Fortunately for the hand sanitizer industry, the virus has increased sales exponentially. The Illinois Department of Health officially recommends: “Provide hand sanitizer (with at least 60% alcohol) and sanitizing products for employees and customers”. We’ve noticed many of our soap, sanitizer, and personal care customers have experienced an increase in orders, along with the need for a quick turnaround time for their personalized labels.
Has your small business been able to keep up with this rapid increase of demand? Are you producing sanitizer quickly enough? And let’s talk about your hand sanitizer labels. Have you continued printing your own custom sanitizer labels? Or is it time to bring in a custom printing professional to help speed up the process?
The Requirements of Hand Sanitizer Product & Labels
Whether your company is new to the hand sanitizer business in Illinois or you’re well-known in the industry, a few things are certain…
- Your custom hand sanitizer labels need to be in compliance with Food and Drug Administration (FDA) regulations.
- Hand sanitizer labels must be waterproof and oil resistant!
- During COVID-19, your business needs to work with a custom label printer that produces quality work within a quick turnaround time to meet demand.
While hand sanitizer seems straight forward, it’s important to make sure your business is complying with the FDA’s regulations for both the actual sanitizer as well as your labels. Due to the pandemic, the FDA released updated requirements back in March 2020: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency. Since hand sanitizer is considered an over-the-counter drug, you must register with the FDA and be approved to produce and distribute this product.
“On 24th April 2019m the FDA published a final rule stating that the three active ingredients namely benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are the only active ingredients determined to be eligible for evaluation under the OTC Drug Review for use in OTC consumer hand sanitizers.”
Hand Sanitizer Label Compliance
Regarding hand sanitizer labeling, the requirements are as follows:
- Label according to Appendices A-D of the FDA temporary policy depending on application
- Include a batch number and labeler code (5 digit number assigned by FDA for each company. Manufacturers, Packers and Private label distributors are required to apply for the labeler code for drug listing purposes)
- Include your company name and contact info (the FDA does not intend to take action against manufacturers that ordered or printed labels without this information prior to their guidelines)
Hand sanitizer products must have a principal display panel on the front label or the front of the product, as well as a Drug Facts panel on the back label.
Principal Display Panel Label Information
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.
Drug Facts Label Information
Hand sanitizer products are classified by the FDA as an over-the-counter drug because of their bacteria killing abilities. 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. Check the FDA website for more information regarding the labeling of OTC drugs.
Make sure to include the manufacturer’s name and address. Provide 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. This provides credibility and an option for customers to contact you if necessary.
How M&R Label Printers Can Assist Your Business
The M&R Label team is here to help your business be successful and to do anything we can to stop COVID-19 from spreading! As your chosen custom label printer in Chicago, we guarantee the best materials, smart label design, and producing a high quality product you’ll be proud of. You can rest assured knowing that your hand sanitizer labels are in good hands and will be in compliance with the FDA’s label regulations.
We are passionate about our customers and we’re committed to providing all of our clientele with top of the line, turnkey service! This includes quick turnaround times, quality custom labels, competitive pricing, and great customer service. In our 30+ years of manufacturing excellent custom labels in Chicago, we’ve earned a reputation for redefining what is expected of a customized label printing partner.
Regarding hand sanitizer sales during the coronavirus, products continue flying off the shelves and there is no time to waste! Let’s work together to prevent an emergency shortage.
Ready for a custom hand sanitizer label solution? We are ready to assist you!