80% with Denaturant and Fragrance

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.
5. Denaturant
6. Fragrance

Ethyl Alcohol 80% v/v

Antiseptic

Hand Sanitizer helps reduce germs on the skin that may cause disease.

Flammable. Not for Human Consumption

• External Use Only

• Keep away from heat or flame

• Do not use with children less than 2 months old
• Do not use on open skin wounds

If contact with eyes, rinse thoroughly with clean water.

Stop use if irritation or rash appear.

If swallowed, Call Poison Control Center: 800 - 222 - 1222

Apply a palmful of the product in cupped hand, covering all surfaces well with product.

Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles.

Allow to dry without wiping.

Prevent swallowing.

Supervise children less than 6 years old.

• Store between 59° F and 86° F
• Avoid freezing and high heat (above 104° F)

bitrex, distilled water, fragrance, glycerin, hydrogen peroxide

We are adding a different product (81184-005-05), so this is the new label for that new product.

It is not a revision of the old product (81184-003-03) at all.

[Image in the official label — see DailyMed source]