Nobac Fact Sheet Nobac® Instant Foam Hand Sanitizer, based on the active ingredient Benzalkonium chloride, is a unique Patent-Pending formulation featuring 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.
Nobac 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). Nobac 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 Nobac 10X Concentrate.
We’ve received numerous questions regarding Nobac, 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). Nobac 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 Nobac, and is generating additional formulation specific efficacy data to support Nobac 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.
One last point regarding FDA:
One last point is that FDA Enforcement staff always makes the point with us that manufacturers get in trouble for labeling and manufacturing violations first, then with more scrutiny regulatory issues are piled on. Given this, and all of the above, we want to make sure that our customers fully understand the labeling and manufacturing issues regarding Nobac. By working with our customers to assure that all the regulations are followed, everyone's risk will be lower. Contact Mason with any questions.
Why Benzalkonium chloride based Hand Sanitizers?
Benzalkonium chloride based Hand Sanitizers have distinct advantages over gelled alcohol 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, less drying to skin, and will not stain clothing. Published studies report that gelled alcohol gel hand sanitizers actually make 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. Benzalkonium chloride is a 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.
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 Nobac?
Patent-Pending Nobac® 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.
Where can I source the foam dispensers?
Airspray International Incorporated
3768 Park Central Blvd.
North Pompano Beach, FL 33064
Phone: 954-972-7750
Fax: 954-972-7797
Web:
Where can I obtain FDA/GMP consulting expertise for setting-up my plant for Nobac?
SRC
PO Box 1014
Columbia City, IN 46725
Phone: 260-244-6270
Email: shays@srcconsultants.com
Web:
Where can I have Nobac packaged?
Webco Chemical Corporation
420 West Main Street
Dudley, MA 01571
Phone: 508-943-9500
Fax: 508-987-0366
Contact: Mark Ruggeri
Email: markr@webco-chemical.com
Is Nobac Safe for Use?
Nobac® 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
Nobac Instant Hand Foam Sanitizer
Toxicity Profile
Nobac 10X Concentrate
Acute Oral LD50
>5.0 g/kg, Category IV
Acute Oral LD50
>5.0 g/kg, Category IV
Acute Dermal LD50
>2.0 g/kg, Category III
Acute Dermal LD50
>2.0 g/kg, Category III
Eye Irritation
Category III
Eye Irritation
Category I
Skin Irritation
Category IV
Skin Irritation
Category IV
Sensitization
Not a Skin Sensitizer
Sensitization
Not a Skin Sensitizer
Is Nobac Effective?
Nobac® 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 Equivalancy 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
+
+
+
+
+
+
+
+
Nobac
50 ppm
0
+
+
+
+
+
+
+
+
+
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
+
+
+
+
+
+
+
Nobac
50 ppm
0
0
+
+
+
+
+
+
+
+
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
Nobac 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.
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.
