Skin & Hand Sanitizer Product Brief & Efficacy Report
7/30/2009 11:42:58 AM
Instant Hand Sanitizer
MicroArmor Instant Foam Hand Sanitizer is based on the active ingredient Benzalkonium Chloride in a unique non-drying, moisturizing and conditioning, Patented formulation. NSF Approved E3 for no-rinse hand sanitizing, MicroArmor kills up to 99.9999% of most common germs that may cause illness, including E. Coli and MRSA in just 15 seconds. MicroArmor Instant Foaming Hand Sanitizer is available in various size spray, foaming and wipe product configurations.
Benzalkonium chloride based Hand Sanitizers have distinct advantages over gelled alcohol hand sanitizers. While both product forms are FDA Monograph compliant for leave on products, fast acting and allow for use without water or towels, benzalkonium chloride based products are non-flammable, less drying to skin, and will not stain clothing. Published studies report that benzalkonium chloride based hand sanitizers demonstrated greater sustained degerming activity than gelled alcohol gel hand sanitizers that actually became less effective with repeated use and made the skin dirtier, not cleaner due to removal of protective natural skin oils and entrapment of dead skin cells by the polymer thickeners used in the gelled alcohol products (AORN Journal, (68 August 1998), p. 239-251). Benzalkonium chloride, unlike benzethonium chloride, is the only quat active ingredient with a history of use in leave-on, FDA Monograph anti-bacterial skin treatment products. Patented MicroArmor® Instant Foaming Hand Sanitizer produces a fast drying, non-sticky foam that contains unique non-drying, conditioning and moisturizing ingredients, leaves the skin with a soft, refreshing and silky after feel, and does not contain polymer thickeners or silicones.
Typical Properties
Physical form...........................................Amber liquid Light amber liquid
Benzalkonium chloride, active % ............0.1
pH............................................................5.0-7.0 5.0-7.0
Drug Facts
Active ingredient Purpose
Benzalkonium Chloride 0.1%..............................Antimicrobial
Uses ▪ For hand sanitizing to decrease bacteria on the skin
▪ Recommended for repeated use
Warnings
For external use only
When using this product avoid contact with eyes. In case of
eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops,
or if condition persists for more than 72 hours.
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.
Directions ▪ Pump a small amount of foam into palm of
hand ▪ Rub thoroughly over all surfaces of both hands ▪ Rub
hands together briskly until dry
Inactive ingredients Water, dihydroxypropyl PEG-5
linoleammonium chloride, glycereth-2 cocoate,
behentrimonium chloride, dihydroxyethyl cocamine oxide,
fragrance
FAQs
Why Benzalkonium chloride based Hand Sanitizers?
History- Benzalkonium chloride is an alcohol-free antimicrobial compound that has been widely used in the health care industry for more than 60 years in formulas for preservatives, surface cleaners, sterilizing agents, and leave-on, FDA Monograph anti-bacterial skin treatment products. The chemical properties of benzalkonium chloride make it a good candidate for persistent antimicrobial activity for hands and skin.
EJ Singer, “Biological evaluation,” in Cationic Surfactants: Analytical and Biological Evaluation, ed J Cross, EJ singer (New York: Marcel Dekker,1994) 29;
RS Boethling, “Environmental aspects of cationic surfactants,” in Cationic Surfactants: Analytical and Biological Evaluation, ed J Cross, EJ Singer (New York: Marcel Dekker, 1994) 95-135;
J Cross, “Introduction to cationic surfactants,” in Cationic Surfactants: Analytical and Biological Evaluation, ed J Cross, EJ Singer (New York:Marcel Dekker, 1994) 4-28.
Effectiveness- Benzalkonium chloride-based leave-on Hand Sanitizers have demonstrated efficacy in real world environments. When evaluated in Elementary School environments where the importance of proper hygiene practices including hand washing is taught and emphasized, the use of non-alcohol benzalkonium chloride-based leave-on instant hand sanitizers reduced illness absenteeism 30-40% in double-blind, placebo-controlled studies versus hand washing alone.
DL Dyer, AL Shinder & FS Shinder (2000). Alcohol-free instant hand sanitizer reduces illness absenteeism. Family Medicine, 32(9), 633-638;
CG White, FS Shinder, AL Shinder & DL Dyer (2001). Reduction of Illness Absenteeism in Elementary Schools Using an Alcohol-free Instant Hand Sanitizer. The Journal of School Nursing, 17(5), 258-265.
What are the advantages of Benzalkonium chloride-based over Alcohol-based Hand Sanitizers?
Benzalkonium chloride based Hand Sanitizers have several distinct advantages over alcohol-based hand sanitizers. While both product forms are FDA Monograph for leave-on products, fast acting and allow for use without water or towels, benzalkonium chloride based products are non-flammable, non-damaging to skin, are persistent, and will not stain clothing or flooring.
Safety- MicroArmor benzalkonium chloride-based instant Hand Sanitizer is non-flammable. An internet search for alcohol-based Hand Sanitizers and fire will produce multiple hits. Flash fires associated with use of alcoholbased hand hygiene products can have potentially severe consequences for health care workers and their patients.
A published example reported an incidence of flash fire associated with the use of an alcohol-based hand antiseptic agent. The fire occurred when a spark of static electricity ignited the alcohol-based hand gel on the hand of a health care worker who had just removed a 100% polyester gown. The health care worker put the pre-measured amount of alcohol-based hand gel in the palm of her hand from a wall-mounted dispenser. She then removed the 100% polyester gown, placed it on a metal surface, and began rubbing the gel onto both hands. While her hands were damp, she pulled open a metal sliding door, heard an audible static spark, saw a flash of light, and experienced spontaneous flames on the palm of one hand. After the incident, the palm showed redness but no blisters. Flames singed the hair on her arm.
KA Bryant, J Pearce & B Stover (2002). Flash fire associated with the use of alcohol-based antiseptic agent. American Journal of Infection Control, 30 (June 2002), 256-257.
Skin Irritation- Alcohol-based hand sanitizers are effective for occasional use, but long-term, frequent use of the alcohol products can cause skin irritation. Alcohol solubilizes and strips away sebum and lipids that guard against bacterial infections of the skin. Extensive use of alcohol-based hand sanitizers actually increases the skin’s susceptibility to infection by transient disease-causing bacteria. This situation can increase the chances of spreading disease-causing microorganisms among patients.
SC Harvey, “Antiseptics and disinfectants; fungicides; ectoparasiticides,” in Goodman and Gilman’s The Pharmacological Basis of Therapeutics, sixth ed, AG Gilman, LS Goodman, A Gilman eds (New York: Macmillan Publishing, 1980) 964-987;
GL Grove, CR Zerweck, JM Heilman (2000). Comparison of skin condition in a 5-day healthcare personnel hand washing using a new ethanolemollient waterless antiseptic versus Purell or water. Atlanta, GA. Paper presented at the Centers of Disease Control 4th Decennial International Conference on Nosocomial and Healthcare-associated Infections. Abstracts P-S1-62.
Effectiveness and residual activity- Alcohol-based hand sanitizers stop working the instant they dry. The leading manufacturer of alcohol-based hand sanitizers claims that their product kills 99.99% of most common germs that may cause disease in as little as 15 seconds. Alcohol-based hand sanitizers dry in 8-10 seconds, and fall below the efficacious concentration of alcohol in seconds. It has been reported that alcohol-based hand sanitizers offer no residual protection, and that if your hands feel dry after rubbing them together for 15 seconds, an insufficient volume of alcohol gel was likely applied. MicroArmor benzalkonium chloride-based hand sanitizer dries fast, but 10-15 seconds slower than alcohol-based hand sanitizers allowing more than the minimum contact time for complete efficacious coverage, including under fingernails. Additionally, benzalkonium chloride-based hand sanitizers demonstrate 2 to 4 hours of residual protection. Published studies report that benzalkonium chloride-based hand sanitizers demonstrated greater sustained antibacterial activity than gelled alcohol-based hand sanitizers that actually became less effective with repeated use and made the skin dirtier, not cleaner due to removal of protective natural skin oils and entrapment of dead skin cells by the polymer thickeners used in the gelled alcohol-based products. In the referenced study to simulate repeated usage, an alcohol-based and alcohol-free benzalkonium chloride-based hand sanitizer were compared. In the study, subject’s hands were repeatedly inoculated with bacteria followed by application of hand sanitizer, then evaluated for antimicrobial effectiveness. The antimicrobial efficacy of the alcohol-based hand sanitizer showed a markedly decreased antimicrobial efficacy with subsequent contamination and decontamination cycles, whereas the alcohol-free benzalkonium chloride-based hand sanitizer showed a steady increase in antibacterial efficacy. In addition to these objective results, subjects were asked to subjectively evaluate the condition of their hands after the completion of the test protocol. 47% of the subjects who had completed the test protocol with the alcohol-based hand sanitizer reported palmar pain or discomfort, and tended to indicate some discomfort in palmar surfaces for one to several days after the test. In contrast, none of the subjects that used the alcohol-free benzalkonium chloride based formula reported any pain or discomfort of their hands after completing the test protocol.
In summary:
• Benzalkonium chloride-based hand sanitizers had a greater sustained antibacterial
activity than alcohol-based hand sanitizers.
• Alcohol-based hand sanitizers became less effective with repeated use and irritated the
hands of subjects.
• Benzalkonium chloride-based hand sanitizers became more effective without irritation
after repeated use.
(1) Marples, RR, & Towers, AG (1979). A laboratory model for the investigation of contact transfer of microorganisms.The Journal of Hygiene, 82(2), 237-248.
(2) Dyer, DL, Gerenraich, KB, & Wadhams, PS (1998). Testing a new, alcohol-free sanitizer to combat infection. Association of Operating Room Nurses Journal, 68(2), 239-251.
What about Benzethonium chloride based products?
As a side note regarding Benzethonium chloride, Grandfathering status has not yet been established for benzethonium chloride, because of no recorded use for a material time and extent prior to December, 1975. For now anyway, manufacturers/marketers of benzethonium chloride based leave-on hand sanitizer products (products not requiring a rinse) face FDA Enforcement action.
Why MicroArmor?
Patented MicroArmor® Instant Foaming Hand Sanitizer produces a fast drying, non-sticky formulation that contains unique conditioning and moisturizing ingredients, leaves the skin with a soft, silky after-feel, and does not contain polymer thickeners or silicones.
NSF Approval
MicroArmor is NSF Registered (NSF Registration No. 138902) under Category E3 for Food Handlers:
Is MicroArmor Effective?
MicroArmor® Instant Foaming Hand Sanitizer is very efficient at reducing bacteria on the skin, effective against a broad range of pathogenic bacteria in as little as 15 seconds based on results from a Chlorine Equivalency and Time Kill Sudy. Results of the study are available on request.
Time Kill Study
This study is designed to examine the rate of kill of a test substance after inoculation with a test organism. Results are expressed in percent reduction and log reduction of the test organism. Exposure time 15 Seconds
Efficacy Result
MicroArmor Instant Foam Hand Sanitizer demonstrated an available chlorine equivalent to greater than the 200 ppm NaOCl standard control when tested against Staphylococcus aureus and Salmonella typhi.
Is MicroArmor Safe for Use?
MicroArmor® Instant Foaming Hand Sanitizer is very effective at reducing bacteria on the skin, yet very gentle on the skin and eyes.
THE INFORMATION CONTAINED IN THIS REPORT IS PROPRIETARY AND
PROVIDED TO THE RECIPIENT BY MICROARMOR FOR THEIR USE ONLY
IT SHOULD NOT BE MODIFIED, DUPLIATED OR MISREPRESENTED IN ANY WAY
MicroArmor Inc., 38316 Airport Parkway #1, Willoughby OH, 44094
1-877-974-1183