Cleanwell

CleanWell, LLC is an American company which sells products containing a botanically based anti-microbial formulation. CleanWell's patented Thyme Oil anti-microbial technology platform is the basis for their portfolio of EPA registered disinfectants and FDA compliant hand hygiene products. This formulation is significant in the hand sanitizer product space because it is the only non-alcohol, botanically based biomimetic formulation.
Introduction
CleanWell, LLC is based in Denver, Colorado. Original design work was done by IDEO. The company is recognized by PETA and has a no animal testing policy.
In April 18, 2011 the FDA sent warning letters to several makers of non-alcohol hand sanitizers, including Cleanwell, indicating that they were "not aware of sufficient evidence" demonstrating that CleanWell products are "generally recognized as safe and effective". CleanWell responded to the FDA with evidence supporting the product claims. The FDA subsequently issued a Close Out Letter on July 19, 2012 indicating that they had "completed an evaluation of the corrective actions" and concluded that CleanWell had "addressed the violations in the Warning Letter". No further enforcement actions were taken as a result of the Warning Letter and the FDA continues to allow CleanWell to market their Thyme Oil based hand hygiene products as labeled.
Active Ingredient
The active ingredient in CleanWell is a patented formulation of thyme oil, whose active ingredient is thymol.
The U.S. Environmental Protection Agency considers Thyme Oil to be a “Minimal Risk” active ingredient. The EPA has given CleanWell's disinfecting products the lowest possible Toxicity Class Rating (IV) and, because of this rating, they are not required to carry any health or safety warnings on the product label. In 2009 the EPA published a tolerance exemption for the use of Thyme Oil disinfecting products on food and food contact surfaces Thyme Oil in the Federal Register indicating that it poses minimum risk for use around food, pets, and children.
Powered by CleanWell
CleanWell has formed partnerships under their “Powered by CleanWell” program with Seventh Generation Inc. and 3M’s Scotch-Brite brand to introduce a line of co-branded disinfectants based on CleanWell’s thyme oil active ingredient.
 
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