The regulating agency for hand sanitizers is the U.S. Food & Drug Administration (FDA). Some think it is the Centers for Disease Control (CDC) or even the Environmental Protection Agency (EPA), but the final authority is the FDA. The FDA regulates hand sanitizers as “over the counter” drugs (OTC), similar to aspirin and other common pain relievers. In the case of Hand Sanitizers, there are three active ingredients that are approved which are 1) Benzalkonium chloride (BZK), 2) Ethanol (ethyl alcohol), and 3) Isopropyl (rubbing) alcohol. All three actives have the SAME drug claim which is “reduces bacteria on the skin”. It is evident that FDA considers these three active ingredients equivalent for purposes of “reducing bacteria on the skin”. Since the level of user knowledge around BZK products is generally not as high as alcohol products, we will examine properties and mechanisms of BZK Hand Sanitizers (represented by our product FOAM N’ GO) in more detail.
EXCELLENT EFFECTIVENESS OF FOAM N’ GO
It is well accepted that quaternary ammonium chlorides such as the BZK used in FOAM N’ GO are very effective at killing bacteria such as Pseudomonas aeruginosa and Staphylococcus aureus. They also are effective at inactivating enveloped viruses such as Hepatitis B and “Human Coronavirus” at very low concentrations (less than 0.08%). FDA regulations for Leave-On Hand Sanitizers require a minimum of 0.1% benzalkonium chloride (1000 ppm), which is a higher concentration than EPA recognizes as effective for Hard Surface Disinfectants for killing bacteria and inactivating viruses. By comparison, the Hospital Grade Disinfectant 4CQ PLUS when diluted properly yields 850 ppm of “quat”. This makes Foam ‘N Go as active as diluted 4CQ Plus.
THE PROBLEM WITH “GELLING”
In thickened alcohol gels, an alkaline pH is required to “activate” the thickening properties. In terms of skin pH (typically 4.2 – 5.6) the residue left by the activator/thickener system leaves the skin pH at a level up to 100X more alkaline than the normal skin pH. This creates two problems as follows:
- Intact skin is a phenomenally effective protective barrier. The combination of skin oils and perspiration (referred to as the “acid mantle”) serves a variety of functions which include prevention of attack by sun and wind and leaves the skin less prone to dehydration. For healthy skin, the acid mantle inhibits the growth of foreign bacteria and fungi. Alkaline residues on the skin attack the protective functionality of the acid mantle.
- Thickened alcohol gels become less effective with continued use. They leave behind a polymer/biofilm residue which traps and feeds surviving bacteria, leading to decreasing performance with use. Further, while gelling an alcohol product slows the rate of evaporation somewhat, the fast evaporation of alcohols limits effectiveness in-use. The slightly longer dry time of FOAM N’ GO ensures that it achieves actual anti-microbial effectiveness in-use. While the FDA does not allow for residual efficacy claims, this property is recognized in published studies and can be summarized by noting that alcohol evaporates, benzalkonium chloride doesn’t.
A FEW MORE POINTS
Alcohol hand sanitizers are flammable with flash points as low as 60 degrees F, while BZK products are non-flammable. Additionally, alcohol hand sanitizers are responsible for dozens of cases requiring hospitalization each year due to children drinking them. They are very effective at removing skin oils, leaving hands dry with repeated use. Contrast this with BZK FOAM N’ GO which produces a fast drying, non-sticky foam that contains unique non-drying conditioning and moisturizing ingredients, leaving the skin with a soft, refreshing and silky after feel. Combine all of the above facts and it is evident that FOAM N’ GO provides safe and effective hand sanitizing, showing that there truly is more than one way to get there.