HAND SANITIZER - 80% Alcohol - W.H.O. Recommended Formula and Ingredients - W.H.O.-
Recommended Formulations were preferred to the product previously in use because of better tolerability, easier on the
skin. According to the NIH; logistic, economic, safety, and cultural and religious factors have all been carefully
considered by W.H.O. before recommending such formulations for use worldwide. NIH also reports that at present,
alcohol-based handrubs are the only known means for rapidly and effectively inactivating a wide array of potentially
harmful microorganisms on hands. Further stating that for optimal compliance with hand hygiene, handrubs should be
readily available, either through dispensers close to the point of care or in small bottles for on-person carriage. Each
active Ingredient is pharmaceutical quality. Bottles have been kept in quarantine for 72 hours allowing the required time
for any spores present in the alcohol or the new bottles to be eliminated by H2O2 (Hydrogen Peroxide).
Shipped to you in a safety sealed HDPE container with a resealable cap.
DIRECTIONS: Apply a palmful of alcohol-based handrub and cover all surfaces of the hands, rub
hands until dry.
Final Concentrations of each ingredient:
- ethyl alcohol SDA 40-B 190 PF (see Simple Alcohol below)
- glycerol 1.45% v/v
- hydrogen peroxide 0.125% v/v
- For external use only.
- Service Industry Employees
- Educational Facilities
- Health Care Facilities
- In areas lacking accessibility to sinks or other facilities for had hygiene (including clean water, towels, etc.)
- Promotes hand hygiene compliance
- Faster process for hand hygiene
- More convenient hand hygiene
- Hygienic Hand Antisepsis
- An antimicrobial handrub
- Presurgical Hand Preparation
ODOR: maybe unpleasant, but characteristic, not a deterent to use
REFILLING: Do not refill bottle without strict adherence to GMP ("Good Manufacturing
Practices") and norms for cleaning and disinfecting the bottle(s) (e.g. autoclaving or thermal disinfecting is preferred but
boiling or chemical disinfection with chlorine for the requisite time frame is also acceptable if done properly).
OTHER ADDITIVES (or adulteration) to the formulation:
- It is strongly recommended that no other ingredients be added except as specified here.
- Addition of other additives not specified here will require full justification, documented safety, compatibility with the
other ingredients, must be free of viable bacterial spores, plus relevant details included on the product label.
- Alcohol % by v/v: must remain at 75% v/v or higher
- Other Humectants or Emollients: Must be miscible in water AND alcohol, non-toxic, and
- Colorants: may be added so long as safe and compatible with the essential components. But
note that Hydrogen Peroxide (H2O2) may fade the color.
- Gelling Agents: may compromise antimicrobial efficacy as well as present product difficulties.
- Fragrances: not recommended due to allergen risks.
- Water: sterile distilled water is preferred but you may use boiled and cooled tap water which is
free of visible particles.
STORAGE: KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes. Keep away from
flame and heat. Keep container closed to prevent evaporation and contamination. Recommend storage in the container
provided to protect the product from heat and contamination.
In Chemistry, there are 3 main types of alcohol:
So what do all these other numbers mean: 12-A, SDA 35, etc...? The U.S. government regulates alcohol distribution in the U.S. and for export. This is done via the Alcohol and Tobacco Tax and Trade Bureau (called the "TTB", a division of the U.S. Department of the Treasury). TTB has promulgated regulations. Those regulations are codified in the Code of Federal Regulations ("CFR"). Those regulations contain multiple formulas for varying types of alcohol and for various authorized uses. Of course, the formulas began with Formula No. 1. Then there were more formulas and each was sequentially numbered. Sometimes, a formula required a slight deviation of denaturant, use, etc. To maintain order and keep similar related formulas together, a letter after the formula number was added. The "SDA" merely denotes Specially Denatured Alcohol. Essential Depot's Sanitizer utilizes ethyl alcohol that has been specially denatured in compliance with alcohol denaturing Formula 40-B of the Code of Federal Regulations.
- Ethyl (commonly called grain alcohol and ethanol) is the typical alcohol used for drinking/spirits.
- Methyl (commonly called methanol) is typically used as an industrial solvent.
- Isopropyl (commonly called rubbing alcohol) is typically used for disinfecting.