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H1N1 ANNOUNCEMENT
MRSA ALERT Product Bulletin
Wipe Size: 6" x 7.5", (100) Individual Packets/Box
SANI HANDS II These individually wrapped packets provide hand sanitizing capabilities for people on-the-go. Use Sani-Hands II to reduce bacteria on your hands and help reduce the spread of bacteria - PROTECT YOURSELF!
Sani-Hands II premoistened hand sanitizing wipes are formulated for use in food service areas of restaurants, supermarkets and various other settings. They contain an emollient that is GRAS to prevent skin from drying.
PRODUCT DESCRIPTION
Nonwoven cloth saturated with ethyl alcohol gel solution for the antiseptic cleansing of hands. Solution and towel are fragrance-free and dye-free.
CHEMICAL COMPOSITION
Active ingredients: Alcohol (Ethanol). . . . . . . . . . . . . . . . . . . . . . . .65.9% by volume
Inactive ingredients: Water, Propylene glycol, Glycerin, Carbomer, Aminomethyl propanol,
Aloe barbadensis leaf juice, Tocopheryl acetate (Vitamin E).
EFFICACY
In-Vitro Time Kill Study
Purpose - The purpose of this study was to determine how rapidly and effectively
SANI-HANDS® II Hand Sanitizing Wipes killed a variety of gram negative and positive microorganisms including spore forming bacteria at 15 second exposure.
Methodology - Fluid from the wipe was expressed aseptically and transferred to sterile incubator tubes. The tubes were subsequently inoculated with the broth culture of the test microorganism containing up to 108 CFU. After 15 seconds, a small aliquot was removed from each tube and placed in neutralizing media to stop the antimicrobial activity. Percent reduction of each organism was determined using standard plating techniques, and percent reductions were calculated for each organism after incubation.
Conclusion – SANI-HANDS® II Hand Sanitizing Wipes was found to be very effective at killing all 28 micro-organisms listed at right in 15 seconds.
Independent Laboratory – Mycoscience Labs, Willington, CT: June 28, 2004
Viral Studies*
Purpose - The purpose of this study was to evaluate the antiviral properties of SANI-HANDS® II Hand Sanitizing Wipes when exposed to the virus (in suspension) for 15 second exposure period.
Methodology - Fluid from the wipe was expressed aseptically and transferred to sterile tubes. The tubes were subsequently inoculated with the virus suspension and held for the specified exposure period. After each exposure period, a small aliquot was removed and assayed for presence of virus.
|
Virus |
ATCC# |
% Reduction |
|
Herpes simplex virus type 1, Strain F(1) |
VR-733 |
>99 |
|
Human Coronavirus, Strain 229E |
VR-740 |
>99 |
|
Influenza A virus, Strain Hong Kong |
VR-544 |
>99 |
|
Rhinovirus type 16, Strain 11757 |
VR-1126 |
>99 |
|
Rotavirus, Strain WA (University of Ottowa) |
– |
>99 |
Conclusion – In the presence of 5% fetal bovine serum, SANI-HANDS® II Hand Sanitizing Wipes demonstrated a greater than 99% reduction in viral titer after 15 second exposure period against viruses listed.
Independent Laboratory – ATS Labs, Eagan, MN:
June 28, 2004
*The 1994 FDA Tentative Final Monograph does not comment on viral efficacy of
hand hygiene products.
SAFETY:
A.) RIPT
Purpose - To determine the dermal irritation and sensitization potential of SANI-HANDS® II Hand Sanitizing Wipes.
Methodology – Study was conducted in two phases using 216 subjects. The induction phase involved repeated exposure of the product at the same site on each subject three times a week for a total of nine applications. Ten to fourteen days after induction, a challenge patch was applied to a virgin site on each subject for 24 hours. After 24 hours the patch was removed and the site was evaluated for dermal irritation.
Conclusion – SANI-HANDS® II Hand Sanitizing Wipes did not demonstrate a potential for eliciting dermal irritation or sensitization.
B.) Safety In Use
Purpose - To evaluate the dermal irritation potential of SANI-HANDS® II Hand Sanitizing Wipes under exaggerated use conditions following 25 repeated uses.
Methodology – A total of 25 subjects completed the study. Each subject used one wipe on both hands for approximately 30 seconds. This was repeated 25 times with 5 minute intervals between uses. Subjects hands were evaluated at the end of 25 uses.
Conclusion – SANI-HANDS® II Hand Sanitizing Wipes did not demonstrate any potential for eliciting dermal irritation in any of the 25 human subjects.
SKIN MOISTURIZATION
SANI-HANDS® II Hand Sanitizing Wipes contains several emollients, such as, glycerin, propylene glycol and aloe to promote moisturization of skin and help minimize the drying effect of alcohol.
GLOVE USE
It is recommended to allow hands to dry completely after using SANI-HANDS® II Hand Sanitizing Wipes prior to applying gloves.
SHELF LIFE
FDA-OTC stability was conducted for purposes of establishing an expiration date for
the unopened product. Current stability data supports a two year expiration period
from date of manufacture.
FDA FOOD CODE COMPLIANT
SANI-HANDS® II Hand Sanitizing Wipes meet the Food and Drug Administration (FDA)
Food Code, Section 2-301.16.
WARNINGS
For external use only. Flammable, keep away from fire or flame. Do not use if irritation
and redness develop. If condition persists for more than 72 hours, consult a physician.
Keep away from children, unless under adult supervision. If swallowed, get medical
help or contact a Poison Control Center immediately.
|
Microorganism |
Classification |
ATCC# |
% Reduction |
|
Acinetobacter baumanii |
Gram negative rod |
19606 |
>99.999
|
|
Aspergillus flavus |
fungi (mold) |
9643 |
=99.999
|
|
Bacillus megaterium |
Gram positive bacteria |
14581 |
>99.999
|
|
Campylobacter jejuni |
Gram negative rod |
29428 |
>99.999
|
|
Candida albicans |
fungi (yeast) |
14053 |
>99.999
|
|
Clostridium difficile |
Gram positive bacteria |
9689 |
>99.998
|
|
Corynebacterium diptheriae |
Gram positive rod |
11913 |
>99.999
|
|
Enterobacter aerogenes |
Gram negative rod |
13048 |
>99.999
|
|
Enterococcus faecium (multi-drug resistant
including Vancomycin) |
Gram positive cocci |
51559 |
>99.999
|
|
Enterococcus faecalis (Vancomycin, Streptomycin,
and Gentamicin resistant)
|
Gram positive cocci |
51575 |
>99.999
|
|
Escherichia coli
(ESBL Producing, Multi-drug
resistant, derived from clinical
isolate, Klebsiella pheumoniae
ATCC #14714)
|
Gram negative rod |
BAA-196 |
>99.999
|
|
Escherichia coli |
Gram negative rod |
11229 |
>99.999
|
|
Escherichia coli (O157:H7) |
Gram negative rod |
35150 |
>99.999
|
|
Klebsiella pneumoniae |
Gram negative rod |
13883 |
>99.999
|
|
Listeria monocytogenes |
Gram positive rod |
15313 |
>99.999
|
|
Proteus mirabilis |
Gram negative rod |
7002 |
>99.999
|
|
Proteus hauseri (vulgaris) |
Gram negative rod |
13315 |
>99.999
|
|
Pseudomonas aeruginosa |
Gram negative rod |
15442 |
>99.999
|
|
Salmonella choleraesuis serotype typhimurium
|
Gram negative rod |
14028 |
>99.999
|
|
Serratia marcescens |
Gram negative rod |
14756 |
>99.999
|
|
Shigella sonnei |
Gram negative rod |
11060 |
>99.999
|
|
Staphylococcus auereus (MRSA)
|
Gram positive cocci |
33591 |
>99.999
|
|
Staphylococcus auereus (MRSA,Vancomycin tolerant)
|
Gram positive cocci |
700788 |
>99.999
|
|
Streptococcus pneumoniae |
Gram positive cocci |
33400 |
>99.999
|
|
Streptococcus pyogenes |
Gram positive cocci |
19615 |
>99.999
|
|
Trichophyton mentagrophytes
|
fungi (mold) |
9533 |
>99.999
|
|
Vibrio parahaemolyticus |
Gram negative rod |
17802 |
>99.999
|
PERCENT REDUCTION
AFTER 15 SECOND EXPOSURE
Take Sani-Hands II packets with you everywhere!
Download Sani-Hands II Information.pdf
Download Sani-Hands_II_MSDS.pdf
|