What is in your Hand Sanitizer?
What is in your Hand Sanitizer?
In response to the public health emergency, the Food and Drug Administration has pronounced a policy for all facilities compounding certain alcohol-based hand sanitizer products. The guidelines provided by the FDA are crafted by a team of experts who have performed thorough research on hand sanitizer compounding. These guidelines are shared with the general public as a strongly suggested protocol for the temporary compounding of sanitizing rubs. Due to the COVID-19 pandemic, there is a national shortage of hand sanitizer from the leading brands who typically manufacture the product in FDA approved facilities. This has called the FDA to temporarily provide flexibility, with respect to certain impurity levels, in some productions of hand sanitizers. This allows for an increased supply of hand sanitizer and rubs. Many companies, such as distilleries and breweries, have shifted gears to temporarily use their facilities to produce hand sanitizer in response to the national shortage. The FDA has provided detailed protocol, ingredients, and safety guidelines for companies to reference when compounding hand sanitizer. The FDA protocol is intended to encourage clean and safe working environments that will ultimately produce a clean and safe product for the end user. These guidelines are also in place to discourage the hand sanitizer compounding by companies that do not meet USP or FCC requirements.
What is the difference between Ethanol and Isopropyl Alcohol Based Sanitizers?
Ethanol, also known as ethyl alcohol or grain alcohol, is produced using a fermentation and distillation process. Fuel or technical grade ethanol can also be produced with this same method. Fuel and Technical grade of Ethyl Alcohol can include harmful chemicals, including gasoline and benzene, which is a known human carcinogen. These impurities would not be expected from a typical fermentation and distillation process but may be present due to the manufacturing environment (e.g., fuel additives, equipment, containers). In addition, the FDA has received data that indicates certain fuel ethanol products contain excessive levels of acetaldehyde, which appears to be a genotoxic carcinogen when in direct contact with tissues. Ethanol is a widely used chemical compound for a variety of uses and applications including fuel, antiseptics, household cleaning products, and even some consumable goods. While it has historically been used in commonly known hand sanitizer brands for decades, the impurity levels in those blends have always met the strict FDA standards. The national response to produce hand sanitizer rubs has caused non-federally regulated businesses to offer their labor and work space to produce ethyl-based hand sanitizer that may or may not meet the guidelines for proper sanitation and overall safety. Many of the hand sanitizer options that are appearing on the shelves in stores across the country are produced with a lower than necessary alcohol percentage, and they are not meeting the FDA requirements. The hand sanitizers that are less than 80% Ethyl Alcohol are cheaper than the 75% Isopropyl Alcohol based rubs, but do not disinfect or kill virus-spreading bacteria.
Isopropyl Alcohol, also known as IPA or isopropanol, is almost exclusively man-made. Pure IPA evaporates almost instantly. Isopropyl Alcohol is offered in different solutions, purity grades, concentrations, and types. It is the most common and widely used disinfectant within pharmaceutics, hospitals, cleanrooms, and electronics. Isopropyl alcohol, particularly in solutions between 60% and 90% alcohol with 10 – 40% purified water, is rapidly antimicrobial against bacteria, fungi, and viruses. The presence of water in isopropyl alcohol is a crucial factor in destroying or inhibiting the growth of microorganisms. Comparative to other hazardous chemicals, IPA is a skin and lung irritant and accidental ingestion can have harmful effects on your health.
Denatured vs Non-denatured?
Denatured Alcohol is ethanol with a chemical added to remove a compound, thus making it unfit or poisonous for human consumption. This adulterant renders the solution to be impotable. Denaturing is critical because there have been reports of adverse events, including deaths, from ingestion of hand sanitizer. Most reports are from unintentional ingestion in young children. The alcohol should be denatured during production or at the point of compounding the hand sanitizer. Denaturing the alcohol using specific formulas outlined by the FDA gives the alcohol within the hand sanitizer a bitter taste to discourage oral consumption.
The Compounded Finished Product for Alcohol- Based Hand Sanitizers:
- Alcohol (Ethanol) (formulated to 80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (formulated to 75%, v/v) in an aqueous solution.
- Glycerin (Glycerol) (1.45% v/v)
- Hydrogen Peroxide (0.125% v/v)
- Sterile Distilled Water
Which Hand Sanitizer does The Lab Depot Offer?
After performing internal research and partnering with trusted chemical suppliers, we have bottled our own brand of alcohol-based hand sanitizer that is formulated with 75% USP Grade Isopropyl Alcohol. The USP-grade certification ensures that both the isopropyl alcohol and any additives are of the highest purity, potency, and accurate concentration. It is ethanol free with no additional additives or impurities. Our hand sanitizer meets WHO and FDA requirements, while being manufactured in an ISO 9001:2015 accredited, cGMP, and FDA registered facility. We strive to provide accurate and informational resources to assist in educating our customers on the ingredients used to compound hand sanitizer. We understand that this is becoming a more commonly sold product in stores across the United States, so we intend to not only inform, but serve as a source of FDA approved, safe, and effective hand sanitizer.
For more information on DISSOLV, please visit our product page. We offer it in 16 oz bottles with dispensing pump tops which are perfect for your sanitizing stations. For larger quantities, consider purchasing Ricca Topical Hand Sanitizer (sold in 10L or 20L cubes). Contact us directly for availability.
It is important that Isopropyl Alcohol or Ethanol-based hand sanitizer or hand rub is not swallowed. Accidental ingestion can have harmful effects on your health.
For more details concerning and involving the compounding of topical hand sanitizer, you can visit FDA or CDC website below.