We’ve been advised against making our own hand sanitizer by the news, the government and those who believe in “better living by consumerism”. We are told we are not chemists, that hand sanitizer is a drug with which we can harm ourselves or others if not properly mixed (true), and that we’re risking it all for something that in the end is just not as good as what’s commercially available (false). We are scared off and discouraged, made to feel inadequate, dangerous and foolish for even trying. Those in “authority” encourage us to wait for it’s commercial availability so we can buy “properly” made formulations.
But is this dependency really necessary?
Because of the Covid-19 pandemic, hand sanitizer is in high demand. The U.S. Food and Drug Administration (FDA) has lifted the regulations that limit who can produce this item, and is now encouraging companies that don’t usually make hand sanitizer, like pharmacies and other compounders, to use their skills to help meet current need.
The FDA has also developed some guidelines for these providers, to assist with this project. They offer a couple of different formulations, the proper labeling to use on the final sanitizer bottles and even advised that these guidelines are non binding, as long as they specify the difference on the label.
It’s interesting that while the average consumer is discouraged from making this product because of the dangers of an improperly mixed formula, the guidelines state the formula can be manipulated, as long as they say so in their label. Meaning we can end up buying an ineffective sanitizer, and it’s legal.
The FDA’s only concern is that the labeling be correct, not that the product be effective; “guidances are not regulations or laws…[so] they are not enforceable”.
The FDA Guidelines
According to the FDA, this hand rub should include only the following ingredients:
a.EITHER Alcohol (ethanol) that is not less than 94.9% ethanol by volume OR Isopropyl Alcohol
b. Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex
(also known as “food grade”)
c. Hydrogen peroxide (H2O2)3%
d. Sterile water (e.g., by boiling, distillation, or other process that results in water
that meets the specifications for Purified Water USP). Water should be used as
quickly as possible after it is rendered sterile or purified.
Guidelines also require the alcohol used to be denatured. I wasn’t sure what this meant in the context of alcoholic beverages and sanitizer formulations. The only denatured alcohol I’ve seen has been sold as paint solvent and fuel- not something you want on your skin or put in your mouth.
There was no explanation of how to denature or why it’s necessary for the function of the final product. The guidelines themselves only refer to particular products to be used for this purpose, and nothing more.
A quick search later and I learned that the act of denaturing alcohol is actually related to the regulation and taxation of alcohol in the USA. Denaturing makes the alcohol bitter or poisonous to drink so it can’t be sold or used as a beverage. It’s a tax leash and it has nothing to do with the protective properties of the sanitizer.
In other words, it’s legally required for sale but unnecessary for sanitation.
The alcohol I use is a high proof grain alcohol which is sold for drinking. Not wine, not rum and not rubbing alcohol. I use grain alcohol which is ethanol. This kind of alcohol has been used as an antiseptic for centuries. You know the part in the movie where the hero uncorks a bottle with his teeth, spits it aside, and takes a good long swig before pouring the rest over a bleeding wound? This is what they’re supposed to be using, and it is the active ingredient in this formula.
Glycerin(glycol) is a product that can come from either natural or synthetic sources. It’s used in the food, cosmetic and medical industries as a sweetener, first-aid, burn remedy, emulsifier and more. It’s purpose in this formula is as a humectant, as strong alcohol can be drying to the skin. The recommended grade for this ingredient is food/pharmacy grade.
Many of us remember hydrogen peroxide from the toasty hair hair days of the 80’s, when it was used as a bleach. In this case it will serve the purpose of cleanser, killing spores in bottles and in the final product.
As for the water, one can either boil water to sterilize it or purchase distilled water.
The FDA guidelines refers to the WHO’s hand rub formula which was created for in-field use and tested for efficacy. Their formula is designed to be prepared and used medically in location of extreme challenge, like war and desperate poverty. According to the WHO’s documentation, these formulas were tested in 11 sites: “located in Bangladesh, Costa Rica, Egypt, Hong Kong SAR, Kenya, Mali, Mongolia, Pakistan (two sites), Saudi Arabia, and Spain”.
It’s interesting to note the difference between the FDA’s and the WHO’s recommendations regarding denaturing the alcohol. The WHO understands the purpose, but recommends against it for various reasons, one being that it can make the alcohol more toxic than it already is. As a matter of fact, the WHO recommends no other ingredients be added to their formulations at all.
The WHO’s formula:
- Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (75%, v/v) in an aqueous solution
- Glycerin (glycerol) (1.45% v/v)
- Hydrogen peroxide (0.125% v/v)
- Sterile distilled water or boiled, cold water
Nice thing about a recipe in percentages is that it can be scaled to fit a final amount. You can find many different online calculators as well as blog sites that explain how to adjust for batch size. I used the Batch Calculator on Wholesale Supplies Plus as an example for this writing.
(Please note: this is only an example for this writing and has not been tested. This is an example, not a recommendation.)
Efficacy- as good as store bought?
The news on TV and in daily periodicals discourage those of us who “do-it-ourselves” by affirming that a sanitizing mix made at home just won’t measure up to a commercially prepared product. For some, I gather this could be true; especially if they miss a detail like using vodka with only 40% alcohol, when the recipe calls for 80% or more. However, for the experienced self-care practitioner, someone who pays attention to details, there are several factors that discredit this notion.
The efficacy of a hand sanitizer, according to the WHO, FDA guidelines and medical studies*, depends on the active ingredient, alcohol. Not only does the alcohol itself have to have a high concentration but the final product, the sanitizer itself, should be composed of over 60% alcohol. According to the WHO, their formulas have been tested and found effective “both for hygienic hand antisepsis and for pre-surgical hand preparation”.
Having said that, in 2013 there was a study that suggested that the increase of alcohol (mass) and the decrease or complete elimination of the glycerin(glycol), would make the WHO’s recommended formulas even more effective. Apparently the WHO’s formulation didn’t meet the “European norm” for preoperative hand preparation until this modification. And looking at the purpose of glycerin we find that the product made without it may dry the skin…
But the germs will be dead.
Personally, I’m not one to wait too much on permissions and allowances when I have a need. Growing up in the Caribbean, we learned to repair rather than replace. When there wasn’t enough to buy, we learned to do without or rig something up ourselves. It’s here in the mainland where we’re encouraged to ignore self-sufficiency and become dependent.
I like the sense of autonomy, of independence and personal sovereignty that comes with doing things for yourself. Additionally, when you DIY, you know exactly what’s in your products. You get to pick the quality of the ingredients you want to use and you limit the use of added chemicals and unnecessary fillers. You know your ingredients and their purpose. You know the risks you take and you make choices based on this knowing. I learned these ways by need, and now I live it as best I can, by choice.
However this independence comes with an important caveat. Personal accountability is absolutely critical. Self-dominion comes with responsibility. Period.
It is our responsibility to educate ourselves. To research pertinent information and go as far as possible beyond the superficial. It’s our responsibility to study the topic and understand what we’re reading. It’s our responsibility to sit and reflect on that information, to ask questions- even of ourselves- seek answers and figure things out. This self-imposed demand can sometimes feel overwhelming and not worth the time or the effort. It’s like going back to school without the guidance and support of a teacher, and this can be difficult. We may not understand an element or get stuck working out a detail that may be important. We may find that making an item may be more work than we are willing, or have the time, to put into it. How far we go is a matter of personal evaluation, but it requires self-awareness and deep honesty.
It’s important to know when we’re truly in over our heads. We need to understand how things are done and why so that we know when things need to be absolutely precise, and when there is enough wiggle room to experiment. This is especially true when making products for health and wellness. The last thing you want happen is to hurt ourselves, a pet or a family member.
This responsibility extends to our ingredients, our space, and the care for those around us. The assumption that “natural” products are harmless is dangerous and incorrect. Many natural products, even foods, can be incredibly potent and must be handled with respect. I once burned a hole through my skin with apple cider vinegar! The same kind you find in your kitchen cabinet! I always experiment on myself first and I’ll admit, I carry the scars of my mistakes on my skin.
Likewise, grain alcohol is sold as an alcoholic beverage. A drink. Like any other adult beverage we would store in our homes, we need to keep in mind the potential for abuse, misuse and, as with a curious child or rebellious teen, accidental over-ingestion. Alcohol is toxic after all.
Above all we cannot ignore common sense. We are presently in a pandemic. Covid-19 is highly infectious and people are dying. Using hand sanitizer, whether home made or store bought, does not take the place of regular hand-washing, covering your coughs and sneezes, keeping dirty hands away from your face and proper social distancing.
Take care and be well.
(c)A.Nanu Pagan, April 2020
*References and interesting reads regarding the topic…
FDA Guidelines – https://www.fda.gov/media/136118/download
Guide to Local Production: WHO-recommended Handrub Formulations– https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf
Drug Applications for OTC Drugs – “guidelines are not regulations” https://www.fda.gov/drugs/types-applications/drug-applications-over-counter-otc-drugs
Denatured Alcohol Not For Human Consumption https://ec.europa.eu/taxation_customs/business/excise-duties-alcohol-tobacco-energy/excise-duties-alcohol/alcohol-not-human-consumption_en
What is the difference between denatured alcohol and rubbing alcohol?https://generalfinishes.com/faq/what-difference-between-denatured-alcohol-and-rubbing-alcohol
What are the differences between non-denatured ethanol and denatured ethanol- https://labproinc.com/blog/chemicals-and-solvents-9/post/what-are-the-differences-between-denatured-and-non-denatured-ethanol-78
What is denatured alcohol or ethanol? – https://www.thoughtco.com/what-is-denatured-alcohol-p2-603999
Batch Size calculator – https://www.wholesalesuppliesplus.com/Calculators/Batch_Size_Calculator.aspx
Virucidal Activity of World Health Organization-Recommended Formulations Against Enveloped Viruses, Including Zika, Ebola, and Emerging Coronaviruses. –https://www.ncbi.nlm.nih.gov/pubmed/28453839
Hand Sanitizer Alert – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3291447/
Alcohol Sanitizer – https://www.ncbi.nlm.nih.gov/books/NBK513254/#article-17334.s6
Mixing your own sanitizer – NYT – https://www.nytimes.com/article/coronavirus-hand-sanitizer-home-made-diy.html
Alcohol poisoning – https://my.clevelandclinic.org/health/diseases/16640-alcohol-poisoning