SaniX80™ Extreme Sanitizer is registered with the FDA and produced under FDA standards.
SaniX80™ Extreme Sanitizer is manufactured according to the World Health Organization recommendations as adopted by the FDA with the following ingredients:
- Ethanol (denatured with isopropyl alcohol) that has been tested by specific gravity (0.790 g/mL @ 20°C.) to be 100% alcohol by volume – the final ethanol content in aqueous solution is 80% v/v
- Glycerin meeting the United States Pharmacopeia/Food Chemical Codex – 1.45% v/v
- Hydrogen Peroxide Topical Solution USP – 0.125% v/v
- Sterile Water USP
As required by the FDA, no other active or inactive ingredients have been added.
Extremely Important!
We verify and document before the start of production that the Ethanol (active ingredient) starts at 100% alcohol by volume. Then after processing with the other ingredients, but before bottling, testing is accomplished by a hydrometer to verify that the alcohol content of the total finished product is 80%.
SaniX80™ Extreme Sanitizer is manufactured with high-quality products and standards under sanitary conditions with well-maintained equipment fit for the purpose.
FDA labeling requires: “Non Sterile” inscription
The FDA requires that “non sterile” be indicated on the label to advise health care professionals what they are using. The label says “non sterile” because the contents have not been sterilized individually. The bottle, cap and packaging are sterilized during manufacturing, but the alcohol solution is not treated with a separate sterilization process and, therefore, is considered non sterile by the FDA.
