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.

 

 

 

 

 

Maki Creations, Inc.®

Instant Foam Hand Sanitizer 10X Concentrate

 

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

 

 

Test Method for Maki Creations, Inc. (titration)

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