LIFEWISE 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(s)

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To reduce germs and bacteria when soap and water are not available.

Warnings

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

Do not use

Do not use on children less than 2 months of age or on open skin wounds.

OTC - WHEN USING SECTION

Keep away from eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

OTC - STOP USE SECTION

If irritation or rash occurs, stop use and consult a doctor. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply generously. Rub all over both hands until dry.

Other information

Store between 59-86°F (15-30°C). May discolor fabrics and surfaces.

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

RECENT MAJOR CHANGES SECTION

• Update and clarify use cases, warnings, and directions of use. (8/27/2020)
• Update label design. Added link to lifewiseusa.com. Clarified Drug Information panel. (10/29/2020)