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Hand Sanitizer


SPL UNCLASSIFIED SECTION

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:

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • 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.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

Active Ingredient

Denatured Ethyl Alcohol 80% v/v


Purpose

Antiseptic


Use

For hand washing to help decrease bacteria on the skin when water, soap and towel are not available. Recommended for repeated use.


Warnings

For external use only.

Flammable. Keep away from heat or flame. Do not store above 40 degress Celcius (105 degrees Farenheit).


Do not use

Do not use in mouth, ears or eyes. In ase of contact, flush eyes with water.

Do not use on open wounds.


OTC - WHEN USING SECTION

Warnings For external use only. Flammable. Keep away from heat and flame. Do not store above 40 degrees Celcius (105 degrees Farenheit). Do not use in mouth, ears or eyes. In case of contact, flush eyes with water. Do not use on open wounds. Stop use and seek a doctor if redness or irritation develops and persist for more than 72 hours. Do not use on children less than 2 months of age. Children must be supervised in use of this product.


Stop Use

Warnings For external use only. Flammable. Keep away from heat and flame. Do not store above 40 degrees Celcius (105 degrees Farenheit). Do not use in mouth, ears or eyes. In case of contact, flush eyes with water. Do not use on open wounds. Stop use and seek a doctor if redness or irritation develops and persist for more than 72 hours. Do not use on children less than 2 months of age.

Children must be supervised in use of this product.


Child Warning

Warnings For external use only. Flammable. Keep away from heat and flame. Do not store above 40 degrees Celcius (105 degrees Farenheit). Do not use in mouth, ears or eyes. In case of contact, flush eyes with water. Do not use on open wounds. Stop use and seek a doctor if redness or irritation develops and persist for more than 72 hours. Do not use on children less than 2 months of age. Children must be supervised in use of this product.


Directions

Directions Pump or pour as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

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Other information

Warnings For external use only. Flammable. Keep away from heat and flame. Do not store above 40 degrees Celcius (105 degrees Farenheit). Do not use in mouth, ears or eyes. In case of contact, flush eyes with water. Do not use on open wounds. Stop use and seek a doctor if redness or irritation develops and persist for more than 72 hours. Do not use on children less than 2 months of age. Children must be supervised in use of this product.


Inactive ingredients

Inactive Ingredients Distilled Water, Hydrogen Peroxide, Glycerol, Denatonium Benzoate