These products are hand sanitizers manufactured according to the 1994 tentative final monograph for antiseptics with additional guidance taken from subsequent rule makings and guidances.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation).
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (4.2% v/v).
- Aloe Barbadensis Leaf Extract.
- Sterile distilled water or boiled cold water.
- Fragrance
The finished product formulation underwent third party efficacy testing (kill study) to confirm efficacy and product potency.
The hand sanitizer come in 6 different scents. Fragrance free (submitted separately NDC: 76751-211), Lavender (NDC: 76751-611), Orange Blossom (NDC: 76751-511), Mint Citrus (NDC: 76751-111), Charcoal (NDC: 76751-311) and Cucumber Basil (NDC: 76751-411).