Frequently Asked Questions

Sanitizers and Disinfectants. What you need to know.

My hand sanitizer bottle label says it kills germs. However, what percentage of alcohol works?

Always check the ingredients to confirm the percentage and quality of alcohol. 70% alcohol is optimal to kill viruses. In order to kill a virus, the alcohol has to permeate through the membrane of the virus cell. Less than 70% is not enough. And more than 70% acts too quickly and effectively congeals around the cell rather than killing it. Ocean Free Liquid Rub is 80% alcohol. As evaporation begins at a fast rate, the effective alcohol is 70%. It is also important to check the grade of alcohol used. For example: 70% content of a 92% pure alcohol ingredient is effectively only 64% in the end product. We use only 99.99% pure pharmaceutical grade alcohol.

How can I be sure it is effective in killing viruses?

All Ocean Free products have undergone rigorous laboratory testing, and they are proven to kill 99.99% of viruses, germs and bacteria, including yeast, enveloped viruses and coronaviruses. Our products have passed all relevant EN Standard tests – applicable for testing the efficacy of disinfectant biocides. In compliance with Health Canada requirements for Hospital & Professional Healthcare, Professional Food Premises, Commercial and Domestic Uses. Our products have passed the following independent laboratory tests:
• EN 13697 Surface Disinfectant Efficiency Testing
• EN 1500 Hygenic Handrub Efficiency Testing
• EN 1276 Chemical Disinfectants Bactericidal Activity Testing
• EN 1650 Fungicidal or Yeasticidal Activity for use in Food, Industrial & Institutional Areas
• EN 14476 Evaluation of Virucidal Activity for use in the Medical Area
• EN 13727 Bactericidal Activity for use in the Medical Area
• EN 13624 Fungicidal or Yeasticidal Activity for use in the Medical Area
• EN 14348 Mycobactericidal Activity for use in the Medical Area

Is hand sanitizer safe to use for children?

There have been cases of alcohol poisoning in children from sweet smelling hand sanitizers. Children under the age of 2 should not be using the product due to increased probability of ingestion. Ocean Free product is not fragranced, therefore not appealing to children. It is perfectly safe for usage in children over the age of 2, as a preventative measure against infections.

Could the use of hand sanitizer lower my child’s immunity?

Published studies have found that more children are falling ill due to preventable diseases after long term and extensive use of hand sanitizers. Ultra clean environments in early childhood can lead to weakened immunity. This is due to the body’s defence mechanism being in constant fighting mode.

We always recommend the use of soap and water wherever available. Sanitizer should only be used when this is not possible. In the current pandemic circumstances, the benefit of preventative measures can be significant in
keeping our communities safe.

I have heard that Triclosan is used in some sanitizers instead of alcohol, as an antibacterial and anti-fungal agent. Is this a safe alternative to alcohol?

Triclosan is an active ingredient in pesticides, has been known to cause various side effects and has been linked to infertility. It is also connected to the rise of “superbugs” – bacteria and viruses that can resist antibiotics.

We do not use toxic chemicals such as Triclosan in the manufacture of our product. By using chemically synthesized ingredients, costs can be reduced considerably, but with possibly detrimental consequences.

Will continuous use of hand sanitizer damage my skin?

Overuse of any product will have an adverse affect. We do add a softening agent to Ocean Free Gel and Rub to prevent dryness.

Why do many hand sanitizers smell sweet?

That sweet smell can be highly toxic: it is due to the inclusion of a compound called phthalates. These compounds easily leach into foods and then into your body. So using a sanitizer instead of soap before your meal might not be a good idea. Phthalates are endocrine disruptors, linked to asthma and may cause reproductive harm.

We do not use toxic chemicals in the manufacture of Ocean Free product. Our products are fragrance and colour free.

My hands don’t feel clean when using hand sanitizer. Why is that?

Hand sanitizer does not clean residue such as fat or sugar deposits off dirty hands. It is meant to be used as an antibacterial and virucide when hand washing is not an option.

What is Pharmaceutical Grade?

Pharmaceutical Grade ingredients must exceed 99.99% purity and contain no binders, fillers, excipients, dyes, or unknown substances. Pharmaceutical grade is usually a higher purity than Food grade. Ocean Free products are manufactured using only pharmaceutical grade ingredients.

There are universal standards to classify and grade ingredients and chemicals. These include:

  • Technical grade is used for commercial and industrial purposes; however it is not pure enough to be offered for food, drug, or medicinal use of any kind. Purity >90%
  • Laboratory grade is the most popular grade for use in educational applications, but its’ exact levels of impurities are unknown. While excellent for teaching and training, it is not pure enough to be offered for food, drug, or medicinal use of any kind. Typically the same as Technical Grade.
  • Purified grade, also called pure or practical grade, meets no official standard; it is not pure enough to be offered for food, drug, or medicinal use of any kind.
  • Pharmaceutical grade meets or exceeds requirements of pharmacopoeial standards. This grade is acceptable for food, drug, or medicinal use. Purity is 99.99%

What is GMP?

GMP (Good Manufacturing Practices) is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP is typically implemented through the effective use of a quality management system (QMS). Legitimate manufacturers would have their QMS audited by a third party registrar and have ISO 22716:2007 GMP certification; this is a requirement for the manufacture of hand sanitizer.

GMP certification guidelines provide minimum requirements that a manufacturer must meet to ensure that their products are consistently high in quality, from batch to batch and for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.

What is a NPN?

NPN stands for Natural Product Number and is issued by Health Canada. You can identify licensed natural health products (NHPs) by looking for the eight-digit NPN on the label.

Normally the safety and efficacy of NHPs and their health claims are supported by proper evidence so that consumers and Health Canada know the products are safe and effective. Evidence can include, laboratory tests, clinical trial data or references to published studies, pharmacopoeias and traditional resources.

In addition, all Canadian manufacturers, packagers, labellers, and importers of natural health products must have site licenses. Site licensing requires maintenance of proper distribution records, procedures for product recalls, work instructions for the handling, storage and delivery of their products, and demonstration that good manufacturing practice requirements are met.

During the Covid-19 pandemic, Health Canada has issued an interim order. This allows expediting processing of applications where safety and efficacy reviews, and manufacturing standards are not required while the interim order is in place. For all products licensed during this pandemic, Health Canada does not require proof of ISO 22716:2007 GMP certification, does not require proof of efficacy of the finished product and is not enforcing the use of pharmaceutical grade ingredients.

Ocean Free products are manufactured in an ISO 22716:2007 GMP certified facility, with pharmaceutical grade ingredients and all products have been independently laboratory tested for efficacy. Further, our distribution facility is ISO 13485:2016 medical certified. We hold an MDSAP license valid in Canada, USA, Brazil, Australia and Japan for the manufacture and distribution of medical devices.

What does Technical Grade mean?

Technical grade components are used for commercial and industrial purposes. They are not considered pure enough to be offered for food, drug, or medicinal use.

Technical grade ethanol has purity standards that are not as strict as pharmaceutical grade ethanol. Technical grade ethanol may contain acetaldehyde in a concentration of 800 to 1000 parts per million (ppm). The maximum allowable level for acetaldehyde in pharmaceutical grade ethanol is in a concentration of 10 ppm. Acetaldehyde is considered toxic, an irritant and a carcinogen with high exposure and longer duration of use.

Both Health Canada and US FDA have issued statements regarding toxicity of technical grade Ethanol used in Hand Sanitizer.

On April 13, Health Canada released a risk assessment. “The risk assessment concluded that acetaldehyde exposure from ethanol-based hand sanitizers is not expected to result in acute toxicity, high irritation or sensitization. However, concerns remain about potential carcinogenicity due to an increase in acetaldehyde exposure, particularly if the hand sanitizer is used for a longer duration.”
https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/covid19-technical-grade-ethanol-hand-sanitizer/risk-assessment-summary-report.html

On April 15, the US Food and Drug Administration, in an updated guidance for alcohol production from ethanol, pointed to a specific issue: “It may be toxic. One concern with impurities data submitted by some fuel ethanol companies is the unacceptable levels of known carcinogens (cancer causing agents), such as benzene, as well as formulas containing gasoline”
https://lite.cnn.com/en/article/h_5a3e0b373307d03ba3380ea3d1b01f8b