x
closebutton

Corporate Statements

Friday, March 26, 2021

Manufacturer’s Guidance for PURELL® Hand Sanitizer Products

It is unsafe and unlawful to use PURELL® Hand Sanitizer packages (dispensing systems and pump bottles) to dispense products other than PURELL® Hand Sanitizer.

Hand sanitizers are FDA-regulated OTC drug products that are produced and marketed as required under FDA Topical Antimicrobial Drug Products Monograph.

GOJO Industries develops, tests, manufactures and markets its PURELL® Hand Sanitizer products in strict accordance with FDA requirements. PURELL® Hand Sanitizer packages present key product information such as lot codes, expiration dates, and drug facts that are required by the FDA.

WARNING: Doing any of the following, could expose people to serious bodily harm/injury and could expose you or your business to legal action or liability.

  • Using PURELL® branded packaging to dispense other products:

    • Is misleading
    • Is a violation of federal and state trademark law*
    • Is a violation of the Federal Food, Drug, and Cosmetic Act**
    • Is a violation of Federal Food, Drug, and Cosmetic Act CGMP regulations***
  • Mixing PURELL® Hand Sanitizer with other products could result in chemistry that:

    • Is not effective in killing germs
    • Could cause bodily harm or injury

*See Lanham Act at 15 USC sections 1051 et seq.

**Under the Federal Food, Drug, and Cosmetic Act, a drug product label that contains false or misleading information causes the drug product to be misbranded. Using PURELL® product containers and dispensers that contain non-PURELL® product causes them to be misbranded because the product labeling is no longer truthful and is misleading, including with regard to the ingredients, expiration date, and origin of the product.

***The failure to comply with Currently Good Manufacturing Practice (CGMP) requirements renders drug products adulterated as a matter of law.

We Can Support Your Needs

When people see PURELL® hand sanitizer, they expect an experience that is safe and effective. That’s because every PURELL® hand sanitizing product that leaves our facilities is manufactured according to strict FDA safety regulations.

PURELL® products are available now. Find more information here.

DOWNLOAD Manufacturer’s Guidance for PURELL® Hand Sanitizer Products

If you are looking for more information or have any questions about this communication, please call GOJO Customer Service at 1-800-321-9647.

Media

Contact Information

Contact: GOJO Public Relations

Email: News@GOJO.com

This contact information is for journalists only. Please include your contact information and deadline in your message.

For all other inquiries, please contact GOJO customer service at the GOJO Contact Us form.