World Health Organization (WHO), Centers for Disease Control & FDA SEEKING

“PERSISTENT ANTISEPTICS”IN HOSPITALS & MEDICAL CLINICS

SHBAN™ Alcohol Free Persistent Antiseptic Solution

vs. Alcohol Gels

© 2012 – 2014 – LifeBionix, Inc.

CDC DEFINITION OF “PERSISTENT ACTIVITY” of an antiseptic or antimicrobial

Persistent activity. Persistent activity is defined as the prolonged or extended antimicrobial activity that prevents or inhibits the proliferation or survival of microorganisms after application of the product. This activity may be demonstrated by sampling a site several minutes or hours after application and demonstrating bacterial antimicrobial effectiveness when compared with a baseline level. This property also has been referred to as "residual activity." Both substantive and nonsubstantive active ingredients can show a persistent effect if they substantially lower the number of bacteria during the wash period.

Source:

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm

WHO, CDC & FDA SEEKING “PERSISTENT ANTISEPTICS”

Alcohol Gels alone are not a “persistent antiseptic” SHBAN’s active ingredient “povidone-iodine” is a

“persistent antiseptic”*. A persistent antiseptic is one that lasts for hours.

SHBAN has been shown to last 4 to 6 hours in laboratory tests.

SHBAN has substansive & non-substansive active ingredients

*Federal Register, Vol 59, No 116, Friday, June 17, 1994, pages 31402-31452

Proof “persistent antiseptic” works better in hospitals over alcohol gels

Virginia Hospitals Reduce Infections 41% Using “Persistent Antiseptic” RICHMOND, Va., June 23, 2011 /PRNewswire/ -- Four hospitals serving

Virginia patients reduced healthcare-acquired infection rates (HAIs) a collective 41 percent within 90 days, resulting in savings of $1.2 million in additional costs to the health care delivery system. Adding a persistent action plan to existing federal hand washing protocols, these hospitals improved patient safety and quality, reported 59 fewer infections and reduced patient length-of-stay and unnecessary readmissions.

Why Hospitals & Doctor’s Offices Should Not Use Alcohol Gel Hand Sanitizers!

The Poison Control Center has reported over 22,000 incidents of alcohol poisoning of children and adults over the past 3 years

Source: CBS News April 21, 2010 “Hand Sanitizers Pose Danger” By Stephany Fisher, Anchor

FDA & US House of Representatives are holding Hearings on Johnson & Johnson’s Purell due to over 1,000 complaints

Source: Reuters News May 26, 2010 FDA Probes Hundreds of J&J Children Drug Complaints

More Reasons Why Hospitals Should Not Use Alcohol Gel Hand Sanitizers!

Alcohol Gels only work when they are wet. There is no protection when your hands are dry. A recent published study by Dr. Gunter Kampf of Medline Industries proved that

“62% ethanol hand sanitizers do NOT provide any more bacterial reduction than simply washing with water alone.”

To be effective a person would have to use 3.2 grams of alcohol and wash hands with alcohol for 120 seconds!

Source: Marketwire News –March 30, 2010 New Study Raises Questions About Foam Hand Sanitizers Antimicrobial Efficacy –

Medline Inc. Alcohol Gels are Flammable! A Class I Fire Hazard. This is a huge legal and safety liability!

A nurse in Sweden put alcohol gel on her hands and started to push a patient in a wheel chair before her hands were dry and a static electricity spark from the wheel chair ignited her left hand on fire.

Source: http://www.thelocal.se/22266/20090924/ September, 2009

More Reasons Why Hospitals Should Not Use Alcohol Gel Hand Sanitizers

Alcohol Prep Caused Surgical Fire A reminder of the importance of letting preps dry before surgery begins. Published:August 15, 2013 SafetyElectrosurgeryNews A North Carolina hospital says it will no longer use alcohol-based skin

preps during emergency surgeries after a patient suffered first- and second-degree burns to the neck and shoulders during what is described as a life-saving procedure in June.

A brief flash fire started when vapor from the skin prepping solution ignited, according to a spokeswoman at FirstHealth Moore Regional Hospital in Pinhurst, N.C., The OR team immediately extinguished the fire and the patient's injuries were not lasting. Most alcohol-based preps require 3 minutes or more of drying time.

Although hospital leaders determined the staff responded to the fire appropriately & successfully, the state division of health service regulation placed the hospital on "immediate jeopardy” list.

Alcohol Gels burns like napalm!

Recommended

3 mL Dose of

Alcohol Gel on fire!Terrorists could take

over a Hospital with

One cigarette lighter &

Use Alcohol Gel

To burn & torture patients

& Destroy the hospital

Why NOT to use Alcohol gels!

Some USA & State Government Agencies are banning alcohol gels in their buildings due to their Class I fire hazard rating.

Source: Michigan Fire Marshall Bulletin – 12, Edited August 20, 2009

Alcohol Gels ruin floor finishes & stain

jewelry worn on hands. (Just ask anyone who must clean floors where alcohol is spilled.)

FAQ: How do I use alcohol gel products?

Response: Thoroughly wet hands with product (minimum 3.0 mL). Rub hands together briskly until dry. No rinsing required. No towels needed.

LifeBionix Comment: The recommendation of the CDC is that recurrent use of alcohol based gel hand sanitizers is not recommended without adequate hand washing between uses; gels leave a biofilm on skin surfaces that trap dirt and potentially pathogenic organisms. Alcohol based gels show decreased effectiveness with added use. Alcohol gels are ineffective upon third use without first washing hands.

SHBAN Antimicrobial Solution Benefit: SHBAN not only kills tested bacteria, inhibits

or binds viruses, yeast and fungus; but also removes dirt from your hands. SHBAN can be used repeatedly without first washing your hands.

FAQ: How can I tell that the alcohol gel hand sanitizer is working?

Response: Alcohol Gel Hand Sanitizer works as the alcohol evaporates.

LifeBionix Comment: The evaporation time for applied alcohol gels is less than 30 seconds with a nickel size dose (min 3.0 mL). Evaporation time for hand gels is inadequate for consistent and proper antimicrobial action.

SHBAN Antimicrobial Solution Benefit: SHBAN leaves a layer of germ killing ingredients that bonds to the amino-acids on your hands.

*IMPORTANT: SHBAN Antimicrobial Solution continues to kill for 3 to 4 hours providing persistent superior antiseptic protection (based on laboratory tests).

FAQ: Can alcohol gel hand sanitizer be used between hand washing?

Response: Yes. Alcohol Gels are a sanitizer, not a cleaner; meaning that it will kill germs, but will not remove blood, dirt, grease, or grime off hands.

LifeBionix Comment: With the third use, alcohol gel products become inefficient and hands need to be washed. Dirt, grease and grime inactivate alcohol in the gel system.

SHBAN Antimicrobial Solution Benefit: SHBAN can be used as often as necessary. SHBAN washes off blood, dirt, grease & grime from your hands. Heavy contamination may require more frequent application.

FAQ: How long after I use the alcohol gel hand sanitizer does it kill germs?

Response: Alcohol Gel products have no residual germ-killing effect.

Alcohol Gel products kill germs (not viruses) on contact, but once it has evaporated (30 seconds), germ-killing action ceases.

LifeBionix Comment: Alcohol Gel evaporation 30 second period is inadequate to kill many pathogenic bacterial, enveloped and non-enveloped viruses; It does not provide residual protection.

SHBAN Antimicrobial Solution Benefit: SHBAN leaves a persistent microfilm of germ killing and viral inhibiting ingredients that continue to thwart the re-colonization of micro-organisms for up to 4 hours unless you sweat, wash or rub the SHBAN off.

FAQ: How can alcohol gel hand sanitizer help to protect you?

Response: Since over 80% of all infectious illnesses are spread by the hands, effective hand hygiene with products like Alcohol Gel Hand Sanitizer can prevent illness. (Alcohol Gels kill 99.99% of most common germs that may cause illness). Hand hygiene is recognized by the Center for Disease Control (CDC) as the single most important means of preventing the spread of infection. Effective hand hygiene kills germs that are easily spread by hands.

LifeBionix Comment: No clinical studies could be found in any of the medical data bases (Medline or Pubmed) that show that less than 30 seconds is an adequate dwell time for alcohol based gel products to work effectively. If you use the ASTM test standard with pathogenic organisms you will find that it is not adequate.

*Pfizer does not publish it’s Purell Alcohol efficacy list of product sensitive organisms. It relies on historical data for pure ethanol products without a gel base.

SHBAN Antimicrobial Solution Benefit: SHBAN has been clinically proven to kill most common species of bacteria, inhibit or bind viruses, yeast and fungus over time.

*IMPORTANT: SHBAN Antimicrobial Solution’s active ingredient Povidone-Iodine 10% has also been proven to kill antibiotic resistant bacteria (MRSA).

FAQ: How often should I use Alcohol Gel as a hand sanitizer?

Response: Alcohol Gel products can be used to disinfect hands whenever they are not visibly soiled and can be used repeatedly. There is no need to wash hands between uses, unless they become visibly soiled or come in contact with blood borne pathogens or body fluids.

LifeBionix Comment: Alcohol gel products have no residual germ killing protection. You will pick up (contaminate yourself) with potentially pathogenic organisms as soon as the alcohol dries. For some protection, alcohol based hand sanitizers need to be used every 5 minutes when in a dirty environment.

SHBAN Antimicrobial Solution Benefit: SHBAN cleans as it sanitizes, there is no inactivation by organic soil so you can use it as often as you would like. U of VA studies showed that only a touch up of a persistent antiseptic on finger tips is required to maintain full antiseptic properties on the hands. A full hand saturation is NOT necessary every time during the first few hours of use.

*IMPORTANT: SHBAN Antimicrobial Solution can be used to remove dirt and grease by using an excess application and drying with a cloth or paper napkin.

FAQ: What germs does Alcohol Gel hand sanitizer kill? What is it not effective against?

Response: Alcohol Gel Hand Sanitizer with 90% plus alcohol is effective against a wide variety of organisms including E. coli, Staphylococcus sp., Streptococcus sp., Salmonella sp. at > 99.99%. Few alcohol gels have 90% alcohol because they are too flammable and too harsh on human hands.

LifeBionix Comment: To meet the FDA OTC (Over The Counter) drug monogram for hand sanitizers, the active ingredient must be able to kill the above organisms. Most alcohol based gel product studies done to meet this requirement were done with pure alcohol (90%+), without the gel base and without the presence of organic soil. Most alcohol gel hand sanitizer’s are 61% to 65% alcohol. Not strong enough to kill viruses.

SHBAN Antimicrobial Solution Benefit: SHBAN was independently tested using the actual clinical isolates when possible.

*IMPORTANT: SHBAN Antimicrobial Solution has been clinically tested in an independent laboratory and proven to inhibit (bind) H5N1 Avian Bird Influenza A virus, H1N1 (Swine) Influenza A, as well as, a variety of multi-antibiotic resistant bacteria, viruses, yeast and mold (See Index).

FAQ: Does Alcohol Gel Hand Sanitizer kill the good and bad germs?

Response: Yes, however, because Alcohol Gel Hand Sanitizer has no residual

antimicrobial activity, the natural flora left in the skin will resurface and repopulate quickly. Alcohol Gel Hand Sanitizer does eliminate some good germs while it gets rid of bad germs. So does washing with soap and water.

LifeBionix Comment: We really don't know what Alcohol Gel kills. Pfizer speaks in general terms.

SHBAN Antimicrobial Solution Benefit: SHBAN has been tested on many different bacteria, viruses, yeast and fungus.

FAQ: Does Alcohol Gel Hand Sanitizer contribute to antimicrobial resistance?

Response: No, because alcohol evaporates completely and none is left behind to promote adaptation.

LifeBionix Comment: Residual organic material on hands and Alcohol Gel evaporation 30 second period which is inadequate to kill many pathogenic bacterial, enveloped and non-enveloped viruses may allow organisms to mutate into other resistant strains.

SHBAN Antimicrobial Solution Benefit: SHBAN does not contribute to microbial resistance.

*IMPORTANT: Due to the povidone-iodine and high pH nature of SHBAN Antimicrobial Solution, organisms are thwarted from reproducing thus hindering the development of resistance genes. There are no known mutated strains that have developed resistance to the SHBAN Antimicrobial Solution.

FAQ: Is product FDA approved?

Response: Alcohol Gel Hand Sanitizer does meet the requirements in the FDA's Tentative Final

Monograph for Topical Antimicrobial Products and the FDA's Good Manufacturing Practices (GMP) requirements for a “persistent antiseptic”. Unless

a carcinogenic ingredient is added to the gel, such as Triclosan that has been banned by many countries including the EU & Canada.

LifeBionix Comment: SHBAN Antimicrobial Solution is regulated under the FDA Tentative Final Monograph and is manufactured under strict GMP manufacturing standards.

SHBAN Antimicrobial Solution Benefit: SHBAN’s active ingredient Povidone-Iodine is recognized by the FDA as a CLASS I – “persistent antiseptic” and does meet the requirements in the FDA's Tentative Final Monograph for Topical Antimicrobial Products and the FDA's Good Manufacturing Practices (GMP) requirements granted to hand sanitizer products that contain a minimum of 5% povidone-iodine. Our hospital grade SHBAN contains 10% povidone-iodine (1% active)

What about clinical testing of SHBAN’s “active ingredient”?

Double-Blind Study of the Effects of SHBAN Solution on Bacterial Plaque & Gingival Inflammation in Dogs, Principal Investigator Christopher W. Dutler, DDS, PhD, Co-investigators Edith Morrison, M.D. Ph.D, Raul Caffessee, DDS, MS Baylor College of Dental Medicine, Dallas, Texas. Results: SHBAN has potent anti-plaque activity, while enhancing gingival healing and connective tissue reattachment. SHBAN does not promote unsightly calculus formation of staining as does Peridex®. Data suggests that SHBAN may be superior in many ways to a commercially successful mouth rinse marketed by Proctor & Gamble.

Additional clinical test results

Comparison of bactericidal activities of various disinfectants against Methicillin-sensitive Staphylococcus aureus and methicillin-resistant Staphylococcus aureus. Yasuda T, Yoshimura S, Katsuno Y, Takada H, Ito M,

Takahashi M, Yahazaki F, Iriyama J, Ishigo S, Asano Y, Dept of Pharmacy, Ohgaki Municipal Hospital Japan. RESULTS: All strains were killed within 20 seconds after disinfection with

SHBAN’s active ingredient povidone-iodine. COMPARISON OF SHBAN VS BETADINE POVIDONE-IODINE COLOR BETADINE RED COLOR SHBAN COLORLESS LIKE WATER

Index – Clinical Source

SHBAN’s persistent active ingredient, povidone-iodine has been clinically tested in over a score of various university, medical university and independent laboratories around the world. PVP-I has over 65 years of proven antimicrobial history.

SHBAN™ (SHBAN Antimicrobial Solution), in previous in vitro and in vivo testing has been evaluated for its antimicrobial properties against:

1) S. Aureus, 2) S. Epidermidis3) EC. Faecalis, 4) E. Coli and Ps. Aeruginosa. 5) Tests revealed that SHBAN™ (SHBAN Antimicrobial Solution) was extremely effective

against all species of bacteria that were tested.

SHBAN™ (SHBAN Antimicrobial Solution) has previously been tested by Baylor Medical Center in Houston, Louisiana State University, UT Houston, Allergan, Pathology Associates, MBA Labs and Texas A&M College of Veterinary Medicine and is protected under FOUR (4) Granted US Letters of Patent #5,514.808, #5,574,050, #5,679,711 and #5,585,391.

Cost Comparison

P R O D U C T Size Price/bottle * $ Per Use Cost

SHBAN™ SHBAN Antiseptic 946mL $38.00 $ .017

STERIS® Antiseptic Hand Gel 946mL $ 8.99 $ .029

PURELL® Sanitizer Gel Refill 1200mL $24.73 $ .036

Germ-X® Hand Sanitizer 443mL $ 4.99 $ .017

*Recommended SHBAN MSRP (SHBAN Antimicrobial Solution) spray size per use is .4mL.

**Recommended Alcohol Gel size per use is 3.0 mL

Note: Prices were quoted week of January 14-18, 2010 / .4mL is a conservative amount; actual spray size is closer to .25mL yielding 3,784 applications per 946mL container or 6X applications compared to alcohol gel products.

SHBAN Antimicrobial Solution Summary

SHBAN Antimicrobial Solution contains between 2365 – 3784 applications per 946mL effectively providing 3X – 6X more applications per unit (depending upon hand size and amount of soiling of hands).

SHBAN Antimicrobial Solution is persistent long lasting and effective up to 3-4 hours vs. alcohol based gel products that have a 30 second killing time after which alcohol gel is no longer effective.

Due to SHBAN’s new patented hydroxyl ion high PH factor, microbes are thwarted from building resistance to SHBAN Antimicrobial Solution.

SHBAN Antimicrobial Solution further reduces administrative costs from a maintenance standpoint due to 1) staff not being required to wash hands as often and 2) dispensers are changed out or refilled less frequently due to higher application rate per container.

Additional Uses For SHBAN

Surgical Use: Surgical spray, swabs and wipes for skin sanitizing preparation prior to surgery, closed wound or surgical site dressing

Oral Use: Gargle Mouthwash-cures gingivitis & periodontal disease, canker sores, sore throat

Gynecological Use: Feminine douche – eliminates odor, candida, feminine itch, will thwart transmission of HIV from male sperm if used prior to unprotected sex

Nasal Use: Sinus infections, ear infections, use in mucus membranes prior to meeting large public crowds, will thwart the inhalation of viruses via the nasal cavity.

Wound Healing: Cools and soothes 1st degree burns, helps improve healing of 2nd and 3rd degree burns after debridement of wounds.

Bug Bites: Stops mosquito bite itching, ant bite inflammation Veterinarian Uses: gingivitis & periodontal disease & dog mouth odor Hot spots on animal skin, wound dressing Poultry Farming: Pen sanitation to prevent H1N5 Influenza A (Avian Bird Flu)

NanoSpray, LLCPhone: 954-454-9217Email: nanosprayusa@gmail.com

On the Web at

www.shban.com

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