
23143
Temescal Canyon Rd, Ste A
Corona, California 92883
Ph. 951-674-4444
Fx. 951-603-0622
|
Overview |
Maki Creations,
Inc.® 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, Maki
Creations, Inc. kills 99.9-99.9999% of most common germs that may cause
illness, including E. Coli and MRSA in just 15 seconds. Maki Creations, Inc.
Instant Foaming Hand Sanitizer is available in a 10X Concentrate, prepared
and shipped to your FDA Registered Establishment, for dilution, addition of
fragrance, and packaging under your name. Benzalkonium
Chloride, which is listed in the Antiseptic monograph as Category III for
safety and efficacy. This category allows Benzalkonium chloride based
products to be marketed in use patterns that fall within the monograph as
long as the formulations conform to the percentage ranges in the monograph,
which is 0.1-0.13% for Benzalkonium chloride. As
in the case of Ethanol based Instant Hand Sanitizers, Benzalkonium chloride
based products qualify for monograph "grandfathering" with a
demonstrated use pattern established for a material time and extent prior to
December, 1975. |
|
Typical Properties |
Maki
Creations, Inc. 10X Conc. Maki
Creations, Inc. RTU Physical form......................... Amber liquid Light amber liquid Benzalkonium chloride, active % 1.0 0.1 Assay (Epton), meq/kg........... 62.0-72.0 6.2-7.2 pH......................................... 5.0-7.0 5.0-7.0 Specific Gravity @25°C ......... 1.00±0.02 1.00±0.02 Flash point (PMCC)................ >200°F(>93°C) >200°F(>93°C) |
|
Handling Information |
Note
- Manufacturing, Packaging and Marketing of this product may be subject to
regulation by the Food and Drug Administration and may be subject to
Enforcement Action. Contact Maki Creations, Inc. for details. Refer to and follow the guidelines in the
Material Safety Data Sheet (MSDS) available from Maki Creations, Inc. for
information on the safe use, handling and disposal of this product. |
|
|
|
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. Leave-on Hand Sanitizers should not be
used as a substitute for proper hand washing and hygiene practices.
Patented Maki
Creations, Inc.® 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
afterfeel, and does not contain polymer thickeners or silicones.
Formula and Mixing
Instructions from Maki Creations, Inc.® 10X Concentrate
Ingredient Weight
%
Maki Creations, Inc. 10X Concentrate 10.0
Fragrance1 0.1 Add
Fragrance to Maki Creations, Inc. 10X Concentrate with mild agitation.
Continue
to agitate until uniform.
Water 89.9 Add Water to Maki Creations, Inc. 10X
Concentrate/Fragrance solution with
mild
agitation. QA, then package.
(1) Maki
Creations, Inc. Fragrance #103099
Intarome Fragrance & Flavor Corporation,
370 Chestnut Street, Norwood, NJ 07648. Ph: 800-631-1566
|
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 |
When marketing Maki
Creations, Inc. Instant Foam Hand Sanitizer as an OTC Antiseptic, FDA Drug
Facts Labeling and OTC Drug Manufacturing guidelines must be followed. The Drug
Facts label illustrated here for Maki Creations, Inc., is an example of
appropriate labeling for this use pattern.
Refer to FDA “Draft
Guidance for Industry Labeling OTC Human Drug Products” at
http://www.fda.gov
for detailed
information on Drug Facts labeling. Refer
to (59 FR 31402) 21 CFR Parts 333 and 369 Tentative Final Monograph for
Health-Care Antiseptic Drug Products; Proposed Rule, FDA-[Docket No. 75N-183H],
RIN 0905-AA06 for specific use pattern guidelines.
In general, any claim that suggests that a product affects the structure
or function of the body is a drug claim. Depending on the claim it may
fall within an OTC monograph or may require an NDA. NDA claims, which are
outside the scope of Maki Creations, Inc. include: antiviral, antifungal, residual
antimicrobial protection, or helps heal skin or helps heal irritation.
Contact Maki Creations, Inc. for Canadian registration, and more details
on labeling, manufacturing and regulatory information. See additional labeling
requirements on the Maki Creations, Inc.
Fact Sheet.
MAC V.012208
Maki
Creations, Inc. Fact Sheet
Maki Creations,
Inc.® Instant Foam Hand Sanitizer, based on the active ingredient
Benzalkonium chloride, is a unique Patented formulation featuring exceptional
skin feel, conditioning and moisturizing properties. The efficacy of this
product has been confirmed to reduce S. aureus 99.9999% in as little as 15
seconds.
Maki Creations,
Inc. Instant Foam Hand Sanitizer is in compliance with the FDA Final Tentative
Monograph for OTC Hand Sanitizer preparations (leave-on sanitizers not
requiring a rinse), and registered in Canada. Maki Creations, Inc. Instant
Foaming Hand Sanitizer is available in a 10X Concentrate, prepared and shipped
from our FDA Registered Establishment, for dilution, addition of fragrance, and
packaging in your FDA Registered Establishment, or the FDA Registered
Establishment of your choice, under your name. We are currently filling orders
for Maki Creations, Inc. 10X Concentrate.
We’ve received
numerous questions regarding Maki Creations, Inc., and the marketing
environment for these types of products. Summarized below are some general
answers:
What are the FDA Regulatory issues relating to Leave-On
Antiseptic Products?
One question that folks will have
relates to the choice of quat active ingredient, either benzalkonium chloride
or benzethonium chloride, and recent issues relating to them. With regard to
benzalkonium chloride or benzethonium chloride and the Agency, note that both
quats are listed in the Antiseptic monograph as Category III for safety and
efficacy. Category III for safety and efficacy means FDA did not have
sufficient efficacy and safety information to list them as Category I for
hand antisepsis. However, this category allows them to be marketed in
products that fall within the monograph as long as the formulations conform to
the percentage ranges in the monograph (Benzethonium = 0.1-0.2%; Benzalkonium =
0.1-0.13% - note this is hard to track in the monograph but we have confirmed
it with FDA). Maki Creations, Inc. Instant Hand Sanitizer is in compliance
with 0.1% benzalkonium chloride.
Even though the monograph is
tentative, products must follow FDA labeling and manufacturing requirements,
but due to case law, the types and extent of efficacy testing is not being
enforced. While Mason Chemical has generated formulation specific
efficacy data confirming Maki Creations, Inc., and is generating additional
formulation specific efficacy data to support Maki Creations, Inc. within
industry practice guidelines, we may be required to generate additional
efficacy data when the Monograph becomes final.
Now, the real issue is that FDA
does not feel that the 1994 TFM includes hand sanitizers (e.g. waterless or
leave-on products). Though there are many paragraphs within the monograph
that suggest otherwise, this is the stance of the Office of Enforcement. So,
today, you can market a quat wash-off product within the above ranges and
complying with the above regulations without concern. However, since the
hand sanitizer use pattern is not part of the monograph in the eyes of Office
of Enforcement, the product may only be on the monograph with an NDA or if it
qualifies for what is called "grandfathering". A product
may be grandfathered, if records can be shown that it was in the market for a
material time and extent prior to December, 1975. Enforcement did the
research to prove that this was true for ethanol hand sanitizers thus they are
"grandfathered". Recently, FDA enforcement staff shared with us
that they have been shown information to allow grandfathering of IPA, IPA and
Ethanol combinations, and benzalkonium chloride. Benzalkonium chloride
"grandfathering" has been confirmed, and FDA enforcement staff
verbally stated to us that thus they plan no further regulatory action against
waterless benzalkonium products that comply with the other items listed
above.
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.
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- Maki Creations, Inc. 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 alcohol-based 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 ethanol-emollient 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(1). Maki Creations, Inc. 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 deliver 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(2).
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 Maki Creations, Inc.?
Patented Maki
Creations, Inc.® Instant Foaming Hand Sanitizer produces a fast
drying, non-sticky foam 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
Maki Creations,
Inc. is NSF Registered (NSF Registration No. 138902) under Category E3 for Food
Handlers:
“This product is acceptable for use as a
hand sanitizing product (E3) in and around food processing areas. This product
may be used only after thoroughly washing hands with soap or detergent and
water, followed by rinsing with potable water. A potable water rinse is not
required after use of this product.”
To note the
"E3" NSF clearance on your product label, you’ll need to submit a
separate distributor subregistration "rebrand product" submission
to NSF. However, since
your formula and the registered Maki Creations, Inc. formula are the same, the
requirement is to only submit the application form with your label and
MSDS.
For guidance on
Maki Creations, Inc. “E3” NSF Registration, contact:
SRC
Columbia City, IN
46725
Bob MacDonald
260-244-6270
bmacdonald@srcconsultants.com
What are the labeling requirements?
When marketing Maki
Creations, Inc. Instant Foam Hand Sanitizer as an OTC Antiseptic, FDA Drug
Facts Labeling and OTC Drug Manufacturing guidelines must be followed. The Drug
Facts label illustrated here for Maki Creations, Inc. is an example of appropriate
Drug Facts labeling for this use pattern.
|
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 |
Refer to FDA “Draft
Guidance for Industry Labeling OTC Human Drug Products” at http://www.fda.gov/cder/guidance/5008dft.htm,
“OTC Labeling:
Questions and Answers” at http://www.fda.gov/cder/otc/label/quesanswers.htm for
detailed information on Drug Facts labeling.
Refer to (59 FR
31402) 21 CFR Parts 333 and 369 Tentative Final Monograph for Health-Care
Antiseptic Drug Products; Proposed Rule, FDA-[Docket No. 75N-183H], RIN
0905-AA06 for specific use pattern guidelines.
In summary, FDA
regulations require certain graphical features for Drug Facts labeling,
including:
· Minimum type size (minimum 6 point)
o
Title: a
type size larger than the largest type size
o
Headings: at
least 8 point or 2 points larger than text
o
Text
and subheadings: minimum 6 point
· A clear, easy-to-read type style such as
Helvetica or Universe with no more than 39 characters per inch
· Left justified text
· Leading: at least 0.5 point
· Kerning: letters cannot touch
· Clearly marked sections with hairlines
between sections
· Bold line surrounding Drug Facts information
· Upper and lower case letters only - no all
caps
· Bullets: solid square or circle, 5 point
type
In addition to
Drug Facts Labeling, the following information must be on labels:
· Statement of Identity: Example - Hand Sanitizer
· Directions & Inactive Ingredients: Covered in Drug Facts Box
· Net Quantity of Contents: fl. oz. and ml. (or Net Wt. oz. and g)
· Name and Place of Business of Manufacturer, Packer or Distributor: Properly qualified if not the manufacturer with "Manufactured for" "Distributed by" or something noting not the manufacturer -
o
Street
Address (It may be omitted if it can be found in a current city directory or
telephone directory.)
o City, State, Zip Code
o
Example:
Your Company, Dist., Your City, YS 00000;
or Distributed by: Your Company, Your City,
YS 00000
· Declaration of Active Ingredient: Covered in Drug Facts Box
· Warning Statements: Covered in Drug Facts Box
· Expiration Dating: 1 Year from Packaging Date
What
claims can be made on the Product Label (other than what’s covered in the Drug
Facts box)?
Maki Creations, Inc. is an Instant Hand Sanitizer and is in compliance with the FDA Final Tentative
Monograph for OTC Hand Sanitizer preparations (leave-on sanitizers not
requiring a rinse), and registered in Canada. In general, any claim that suggests
that a product affects the structure or function of the body is a drug claim,
such as Sanitizing Hands. Depending on the claim it may fall within an OTC
monograph or may require an NDA (New Drug Application), and Maki Creations,
Inc. falls within the Final
Tentative Monograph for OTC Hand Sanitizer.
Claims, which are outside the scope of Maki Creations, Inc. (requiring
an NDA) include: antiviral, antifungal, residual antimicrobial protection, or
helps heal skin or helps heal irritation, or prevents illness.
Cosmetic claims can be listed, such as “leaves hands feeling soft &
refreshed,” “contains moisturizers,” “leaves hands feeling refreshed without
stickiness or residue” and so on.
Targeted use application statements can be listed, such as “use anytime,
anyplace without water or towels,” “keep a bottle at work, in the classroom,
and at home” and so on.
Product specific attributes can be listed, such as “kills 99% (99.9%,
99.99%, 99.999%, 99.9999% all supported by data) of most common germs that may
make you sick,” “the active ingredient is benzalkonium chloride, a safe and
effective antiseptic,””effective against MRSA,” “effective in as little as 15
seconds,” “alcohol-free” and so on.
Is Maki Creations, Inc. Effective?
Maki Creations,
Inc.® 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 as the Chlorine Equivalency and Time Kill Data below
illustrate:
Chlorine
Equivalency Test
The object of this test is to determine the
available chlorine germicidal equivalent concentration of the product as
compared to 200, 100 and 50 ppm available chlorine in the NaOCl standard
controls.
Initial Suspension Population
Staphylococcus
aureus ATCC 6538 7.6 X 108 CFU/ml* *Colony Forming Units per ml of test mixture
Salmonella
typhi ATCC 6539 1.2 X 108 CFU/ml
|
Test Organism |
Test Substance |
Concentration |
Subculture Series |
|||||||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|||
|
S. aureus |
NaOCl Control |
200 ppm |
0 |
0 |
0 |
0 |
0 |
+ |
+ |
+ |
+ |
+ |
|
100 ppm |
0 |
0 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
||
|
50 ppm |
0 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
||
|
Maki Creations, Inc. |
RTU |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
S. typhi |
NaOCl Control |
200 ppm |
0 |
0 |
0 |
0 |
0 |
0 |
+ |
+ |
+ |
+ |
|
100 ppm |
0 |
0 |
0 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
||
|
50 ppm |
0 |
0 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
||
|
Maki Creations, Inc. |
RTU |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
+ = Growth of Organism
0 = No Growth of Organism
The subcultures of positive
broths (tubes showing growth) demonstrated pure cultures of test organism.
Efficacy Result
Maki Creations, Inc. 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 Maki Creations, Inc. Safe for Use?
Maki Creations,
Inc.® Instant Foaming Hand Sanitizer 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 Maki
Creations, Inc. Instant Hand Foam Sanitizer |
Toxicity
Profile Maki
Creations, Inc. 10X Concentrate |
|
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 |
Acute Oral LD50 >5.0 g/kg, Category
IV Acute Dermal LD50 >2.0 g/kg, Category III Eye Irritation Category I Skin Irritation Category IV Sensitization Not a Skin Sensitizer |
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
|
Organism |
Test Population Control (CFU/ml) |
Number of Survivors
(CFU/ml) |
% Reduction |
Log Reduction |
|
Campylobacter jejuni ATCC 29428 |
1.02 X 107 |
<1 X 102 |
>99.999 |
>5.00 Log10 |
|
Candida albicans ATCC 10231 |
1.60 X 105 |
6.0 X 103 |
96.3 |
1.42 Log10 |
|
Clostridium difficile ATCC 9689 |
3.40 X 106 |
<2 |
>99.9999 |
>6.20 Log10 |
|
Enterococcus faecalis Vancomycin Resistant (VRE)
ATCC 51575 |
1.12 X 106 |
3.2 X 101 |
99.99 |
4.54 Log10 |
|
Escherichia coli ATCC 11229 |
3.80 X 106 |
4 |
99.999 |
6.00 Log10 |
|
Escherichia coli O157:H7 ATCC 35150 |
1.26 X 106 |
<2 |
>99.999 |
>5.80 Log10 |
|
Klebsiella pneumoniae ATCC 4352 |
1.10 X 106 |
2 |
99.999 |
5.70 Log10 |
|
Listeria monocytogenes ATCC 19117 |
4.7 X 106 |
1.9 X 103 |
99.9 |
3.39 Log10 |
|
Pseudomonas aeruginosa ATCC 15442 |
3.5 X 106 |
<2 |
99.9999 |
>6.20 Log10 |
|
Salmonella choleraesuis serotype enteritidis ATCC 4931 |
6.8 X 105 |
2 |
>99.999 |
5.50 Log10 |
|
Salmonella choleraesuis serotype paratyphi ATCC 8759 |
5.6 X 105 |
<2 |
>99.999 |
>5.50 Log10 |
|
Salmonella choleraesuis serotype pullorum ATCC 19945 |
8.9 X 105 |
<2 |
>99.999 |
>5.70 Log10 |
|
Salmonella choleraesuis serotype typhimurium ATCC 23564 |
7.7 X 105 |
6 |
>99.999 |
>5.10 Log10 |
|
Salmonella typhi ATCC 6539 |
1.27 X 106 |
2 |
99.999 |
5.80 Log10 |
|
Shigella dysenteriae ATCC 13313 |
1.3 X 106 |
<2 |
>99.999 |
>5.80 Log10 |
|
Shigella flexneri ATCC 12022 |
1.39 X 106 |
2.8 X 101 |
99.99 |
4.69 Log10 |
|
Shigella sonnei ATCC 25931 |
2.43 X 107 |
2.0 X 101 |
99.9999 |
6.09 Log10 |
|
Staphylococcus aureus ATCC 6538 |
6.7 X 106 |
<2 |
>99.9999 |
>6.53 Log10 |
|
Staphylococcus aureus Methicillin Resistant
(MRSA) ATCC 33592 |
1.23 X 107 |
3.8 X 103 |
>99.9 |
3.51 Log10 |
|
Staphylococcus aureus Community Associated
Methicillin Resistant (MRSA) NARSA NRS 123, Genotype USA400 |
1.18 X 106 |
5.8 X 102 |
>99.9 |
>3.30 Log10 |
|
Staphylococcus epidermidis
ATCC 12228 |
7.2 X 105 |
<2 |
99.999 |
5.56 Log10 |
|
Streptococcus pneumonia ATCC 6305 |
6.4 X 105 |
<2 |
>99.999 |
>5.51 Log10 |
|
Streptococcus pyogenes ATCC 19615 |
1.77 X 106 |
<2 |
>99.999 |
>5.90 Log10 |
|
Vibrio cholera ATCC 11623 |
4.7 X 105 |
<2 |
>99.999 |
>5.40 Log10 |
|
Xanthomonas axonopodis (Citrus Canker) ATCC 49118 |
1.28 X 106 |
3.6 X 101 |
>99.99 |
4.55 Log10 |
|
Yersinia enterocolitica ATCC 23715 |
2.23 X 106 |
3.8 X 101 |
99.99 |
4.77 Log10 |
Maki Creations, Inc. actives (Benzalkonium Chloride) concentration can be inferred by titration. Maki Creations, Inc. 10X Certificate of Analysis reports Benzalkonium Chloride Active concentration (determined directly by HPLC(1)), and a titration result for total cationic species (Maki Creations, Inc. contains 3 cationic materials including the active benzalkonium chloride) expressed in meq/kg. Dilution of the total cationic species 10X will necessarily dilute the active benzalkonium chloride 10X. For example: the specification for total cationics by the Epton procedure is 62.0-72.0 meq/kg. A typical Certificate of Analysis might report a value of 65.0 meq/kg with an active Benzalkonium Chloride concentration of 1.1%. Dilution 10X of this Maki Creations, Inc. 10X Concentrate to 6.5 meq/kg will result in 6.5/65.0 x 1.1% Benzalkonium Chloride = 0.11% Benzalkonium Chloride.
Epton Procedure
Reagents needed for the test:
o
Hyamine
1622 solution, 0.004M
o
Sodium
Lauryl Sulfate 0.003N, standardized against Hyamine 1622 solution
o
Chloroform,
A.R. Grade
o
Salt
Buffer Solution – Prepare by adding 7 grams of sodium carbonate, 100 grams of
sodium sulfate to 1000ml distilled water.
o
Methylene
blue indicator solution (1.0% w/v in Denatured Alcohol)
Apparatus needed for the test:
o
1000ml
volumetric flask
o
Analytical
balance
o
Graduated
cylinder, 50-100ml capacity
o
Burette,
25-50ml
o
250ml
stoppered graduated cylinder
Procedure:
1. Catch weigh into a 250 ml stoppered
graduated cylinder 10 grams of Maki Creations, Inc., or 1 gram of Maki
Creations, Inc. 10X (to the nearest
0.0001 grams) and record weight.
2. Add 50 ml of chloroform, 50 ml of salt
buffer solution and 1 drop of methylene blue indicator to the 250 ml stoppered
graduated cylinder.
3. Stopper the cylinder and shake the solution
vigorously. Initial solution is blue in the upper phase and a slight pink to
clear in the lower phase.
4. Titrate with the 0.003N sodium lauryl
sulfate solution. Titrate to a colorless
end-point in the upper phase of solution when viewed before direct light. Lower
phase is dark blue. Titration in duplicate is recommended.
Note: Add
several mls of titrant initially, (to within about 80% of the target) and
then reduce increments progressively to a few drops until reaching the endpoint.
Stopper the cylinder after each addition of titrant and shake vigorously.
Rel
Calculation:
meq/kg = [(mls SLS solution x N of SLS
solution)/sample weight] x 1000