General
HR® Clini-Clean™
- Are Clini-Clean's active ingredients approved by the FDA?
- Is the active ingredient in Clini-Clean safe for use as an antiseptic on skin?
- Are the active ingredients in Clini-Clean recommended by the CDC?
- Does the FDA have an approval process in place for instant hand sanitizers
- Why do alcohol based hand sanitizer dry hands?
The FDA, as the governing body to the CDC, approved the use of Benzalkonium Chloride, as an active and this ruling remains in effect through today.
FDA Federal Register/Vol. 56, No. 140 approved Benzalkonium Chloride.
Benzalkonium chloride, is extremely safe at the low levels that we use and it shows in the testing on RFS 909. The irritation and sensitization testing had zero incidents of irritation. Benzalkonium chloride has been used in many preparations for the past 60 years including eye and nasal drops, leave-on skin antiseptics, hygienic towelettes, and wet wipes. It is extremely safe and tested to be true.
The CDC drafted the “Guideline for Hand Hygiene in Health-care Settings,” with the support of a leading alcohol based instant hand sanitizing company. The CDC recommended alcohol based products but no language exists prohibiting offering an approved alternative and as an option along with alcohol.
CDC Addresses Issue of Non-Alcohol Hand Sanitizers
The FDA, as the governing body to the CDC, approved the use of BAC as an active ingredient (used in Clini-Clean), and this ruling remains in effect through today.
FDA Federal Register/Vol .56, No. 140 approved Clini-Clean active ingredient, Benzalkonium Chloride (BAC) in concentrations of 0.1 to 0.13 percent.
CDC’s MMWR “Guideline for Hand Hygiene in Health-Care Settings” makes a recommendation for alcohol instant hand sanitizers but does not exclude the use of an alternative for children, elderly and those who are allergic or cannot use alcohol due to dry and cracked hands.
It is important to note that the CDC recommendations were established in 1994 and thus do not reflect the advancements in non-alcohol anti-microbials such as Benzalkonium Chloride. The latest generation products are more effective and much safer than alcohol based sanitizers. Low compliance with hand sanitizer use in medical professionals is directly related to the adverse impact alcohol has on the skin. Additives such as gels, Aloe and Vitamin E merely mask the extreme drying effect of alcohol.
The FDA does not have an approval process in place for instant hand sanitizers (Final; Monograph) but instead has published a Tentative Final Monograph (TFM) which is used as a guideline to ensure instant hand sanitizers conform to the guidelines set by the FDA. Clini-Clean's formula meets and exceeds these guidelines.
Alcohol kills germs by stripping away the natural oils of the skin. These oils do not regenerate if alcohol is continuously used throughout the day. When the skin dries, bacteria gets trapped in the skin, therefore making the hands more contaminated with each use of alcohol.
