Hand Sanitizer Technology
Pure Hand Instant Hand Sanitizer Gel, based on the active ingredient Benzalkonium Chloride, is a unique gel formulation that features exceptional skin feel, conditioning, and moisturizing properties. The efficacy of this product has been confirmed to reduce S. aureus 99.999% in as little as 15 seconds.
A wash-off Benzalkonium Chloride offering in the ranges of 0.1-0.13% is recognized under the 1994 TFM for Antiseptic Drug Products when making claims against bacteria. Its leave-on or hand sanitizer use without a rinse is recognized and covered by the OTC Drug Review for antiseptic hand wash, healthcare-personnel hand washes, and surgical scrub uses, with the through requisite prior evidence of it being marketed for a material time and extent prior to December 1975 in the United States for these uses. Therefore, until a final antiseptic monograph is issued and establishes Benzalkonium Chloride in Category I or Category II its (0.1-0.13%) remains in Category III and is allowed to be marketed as a wash-off (rinse) offering per the TFM or as a leave-on because of being in the market prior to December 1975, i.e. Bactine®, developed in 1947 and introduced in 1950.
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 in mammalian tissue. The Cosmetic Ingredient Review (CIR) Expert panel concludes that benzalkonium chloride is safe as a cosmetic ingredient at 0.1%.
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 the skin, are persistent, and will not stain clothing or flooring.
| Pure Hand at 1000ppm active Benzalkonium chloride at 15 second exposure | ||||
| Organism | Test Population Control (CFU/ml) | Number of Survivors (CFU/ml) | % Reduction | Log Reduction |
| Campylobacter jejuni ATCC 29428 | 1.02 X 107th | <1 X 10 2nd | >99.999 | >5.00 Log10 |
| Enterococcus faecalis Vancomycin Resistant (VRE) ATCC 51575 | 1.12 X 10 6th | 3.2 X 10 1st | 99.99 | 4.54 Log10 |
| Escherichia coli ATCC 11229 | 3.80 X 10 6th | 4 | 99.999 | 6.00 Log10 |
| Escherichia coli O157:H7 ATCC 35150 | 1.26 X 10 6th | <2 | >99.999 | >5.80 Log10 |
| Klebsiella pneumoniae ATCC 4352 | 1.10 X 10 6th | 2 | 99.999 | 5.70 Log10 |
| Staphylococcus aureus Methicillin Resistant (MRSA) ATCC 33592 | 1.23 X 10 7th | 3.8 X 10 3rd | >99.9 | 3.51 Log10 |
| Staphylococcus aureus | 1.18 X 10 6th | 5.8 X 10 2nd | >99.9 | >3.30 Log10 |
| Pure Hand at 1000ppm active Benzalkonium chloride at 15, 30 and 60 second exposure | |||||
| Organism | Exposure time seconds | Test Population Control (CFU/ml) | Number of Survivors (CFU/ml) | % Reduction | Log10 |
| Pseudomonas aeruginosa | 15 | 1.72 X 10 6th | <5 | >99.999 | >5.5 |
| Pseudomonas aeruginosa | 30 | 1.72 X 10 6th | <5 | >99.999 | >5.5 |
| Pseudomonas aeruginosa | 60 | 1.72 X 10 6th | <5 | >99.999 | >5.5 |
| Staphylococcus aureus | 15 | 9.6 X 10 5th | 8.0 X 10 1st | >99.99 | 4.08 |
| Staphylococcus aureus | 30 | 9.6 X 10 5th | 2.0 X 10 1st | >99.999 | 4.68 |
| Staphylococcus aureus | 60 | 9.6 X 10 5th | <5 | >99.999 | >5.3 |
| Pure Hand at 1300ppm active Benzalkonium chloride at 15, 30 and 60 second exposure | |||||
| Organism | Exposure time seconds | Test Population Control (CFU/ml) | Number of Survivors (CFU/ml) | % Reduction | Log10 |
| Pseudomonas aeruginosa | 15 | 3.08 X 10 6th | <5 | >99.999 | >5.9 |
| Pseudomonas aeruginosa | 30 | 3.08 X 10 6th | <5 | >99.999 | >5.9 |
| Pseudomonas aeruginosa | 60 | 3.08 X 10 6th | <5 | >99.999 | >5.9 |
| Staphylococcus aureus | 15 | 7.56 X 10 5th | <5 | >99.999 | >5.2 |
| Staphylococcus aureus | 30 | 7.56 X 10 5th | <5 | >99.999 | >5.2 |
| Staphylococcus aureus | 60 | 7.56 X 10 5th | <5 | >99.999 | >5.2 |
Is Pure Hand Safe for Use?
Pure HandInstant Hand Sanitizer Gel is very effective at reducing bacteria on the skin, yet very gentle on the skin and eyes as the Toxicity Profile below indicates:
Toxicity Profile
Pure Hand Instant Hand Sanitizer Gel
Acute Oral LD50 >5.0 g/kg, Category IV
Acute Dermal LD50 >2.0 g/kg, Category III
Eye Irritation Category III
Skin Irritation Category IV
Sensitization Not a Skin Sensitizer
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