Nobac® Instant Foam Hand Sanitizer is based on the active ingredient Benzalkonium Chloride in a unique non-drying, moisturizing and conditioning, Patent-Pending formulation. The efficacy of this product has been confirmed to reduce S. aureus 99.99% in as little as 15 seconds. 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 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
Nobac 10X Conc.
Nobac RTU
Physical form
Amber liquid
Light amber liquid
Benzalkonium chloride, active %
1.0
0.1
Assay (Epton), meq/kg
61.0-69.0
6.1-6.9
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 Mason Chemical Company for details.
Refer to and follow the guidelines in the Material Safety Data Sheet (MSDS) available from Mason Chemical Company 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 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, 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.
Patent Pending Nobac® 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 Nobac® 10X Concentrate
Ingredient
Weight %
Nobac 10X Concentrate*
10.0
Fragrance1
0.1
Add Fragrance to Nobac 10X Concentrate with mild agitation. Continue to agitate until uniform. Warm if necessary.*
Water
89.9
Add Water to Nobac 10X Concentrate/Fragrance solution with mild agitation. Continue to agitate until uniform. QA, then package.
Drug FactsActive 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
When marketing Nobac 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 Nobac, is an example of appropriate labeling for this use pattern.
Refer to FDA “Draft Guidance for Industry Labeling OTC Human Drug Products” at 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 and requirements.
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 Nobac include: antiviral, antifungal, residual antimicrobial protection, or helps heal skin or helps heal irritation.
*Nobac 10X concentrate will become hazy and may separate when stored cold. Gently warm prior to use, with agitation if necessary, to obtain uniform solution. Contact Mason Chemical Company for more details on labeling, manufacturing and regulatory information.
