FDA Policy
The hand sanitizer is compounded using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
- Glycerol (1.45% v/v)
- Hydrogen peroxide (0.125% v/v)
- Sterile distilled water or boiled cold water
The compounder does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
United States Pharmacopeia recipe:
60% Alcohol Hand Sanitizer
- 87.71 mL 70% isopropyl alcohol
- 4.17 mL 3% hydrogen peroxide
- 0.75 mL 98% glycerol
- Water sufficient to make final volume 100 ml
Measure the quantities of Isopropyl Alcohol, Hydrogen Peroxide, and Glycerol in suitable containers. Transfer the Isopropyl Alcohol and Hydrogen Peroxide into a suitable calibrated container and mix gently. Transfer the Glycerol stepwise and quantitatively into the calibrated container. Mix gently after each addition. Rinse the container containing glycerol several times with Water and add the contents to the calibrated container. Add sufficient Water to bring to final volume. Mix well. Transfer the solution into suitable containers.
75% Alcohol Hand Sanitizer
- 75.76 mL 99% isopropyl alcohol
- 4.17 mL 3% hydrogen peroxide
- 0.75 mL 98% glycerol
- Water sufficient to bring final volume to 100 mL
Same mixing instructions as above.
30-day shelf-life for both formulations when stored at room temperature.