Active Ingredient(s)

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(s)

Ethyl Alcohol 70%

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

OTC - WHEN USING SECTION

Do not use in or near the eyes, ears, and mouth.

In case of contact, rinse thoroughly with water.

Do not use in the mouth, mucous membrane, or open skin wound as it may cause irritation.

Take precaution when using if allergic to Propylene Glycol.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

Other information

• Store between 1-30C (33-86F)

Inactive ingredients

WAter, Triethanolamine, Hydrogenated Castor Oil, Glycerol, Propylene Glycol, D-Panthenol, Polyacrylic Acid, Lemon, DL-alpha-Tocopherol Acetate