Hand sanitizers can help reduce the risk of infection by, or spread of, microorganisms1. While no hand sanitizers are approved for COVID-related claims, Health Canada recommends frequent hand washing with soap and water to reduce the risk of infection or the use of an alcohol-based hand sanitizer (or hand rub) if soap and water are not available2. Acceptable alcohol-based hand sanitizers may use ethanol (also known as ethyl alcohol) or isopropyl alcohol (IPA) as the active ingredient. Ethanol and IPA are manufactured in a variety of grades, depending on the intended application. For example, technical grade IPA is used as a laboratory reagent or for electronic equipment cleaning, but it might contain unknown impurities that are unsafe for human use2. Some grades of ethanol contain denaturants or varying quantities of impurities such as methanol, benzene or acetaldehyde3.
To ensure safety, efficacy and purity, Health Canada requires approved alcohol-based hand sanitizers to contain ethanol or IPA manufactured to purity standards for food or pharmaceutical use1,2. Quality standards and testing requirements for acceptable hand sanitizer alcohols are specified by organizations such as the United States Pharmacopeia (USP). USP sets standards for quality, purity, strength, and identity of many medicines, food ingredients and dietary supplements sold in Canada and the United States. Inactive ingredients in hand sanitizers, such as water for dilution of concentrated alcohol, or glycerol as a humectant (moisturizing agent), should also be of high purity, suitable for food or pharmaceutical use.
With the high demand for hand sanitizer during the current COVID-19 pandemic, shortages in high purity alcohol have occurred in Canada. Health Canada has temporarily permitted some manufacturers to use technical or industrial grade alcohol in hand sanitizers. Due to potential health risks from impurities in such products, restricted-use conditions have been applied. Hand sanitizers containing technical or industrial grade alcohol must be labelled for use by adults only, with additional warnings to not use on broken or damaged skin, or by those who are pregnant or breastfeeding. Unfortunately, there have been numerous manufacturer recalls for product lots containing unacceptable impurities such as ethyl acetate and methanol, and for mislabelling5.
Novocol Pharma Isopropyl Alcohol 75% Topical Solution hand sanitizer is manufactured in a Health Canada licensed pharmaceutical facility in Cambridge, Ontario, using Good Manufacturing Practices (GMP). The product is manufactured under a Natural Health Product Regulations (NHPR) license from Health Canada (NPN 80099137). The ingredients are pharmaceutical grade, containing 75% isopropyl alcohol (USP), glycerol (USP), and purified water (USP). A low concentration of food-grade hydrogen peroxide is added to help eliminate contaminating spores in a bulk solution, prior to being filled into bottles. The product is labelled for use by ages two and up. The formulation is in accordance with the World Health Organization (WHO) isopropyl alcohol hand rub formula4 and is fragrance-free, without the use of gelling agents. The bottle size is 500 mL and it is sold in cases of 10 with dispensing pumps supplied for convenience.(references on website)