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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(s)

Denatured Ethyl Alcohol 80% v/v. Purpose: Antimicrobial


Purpose

Antiseptic, Hand Sanitizer


Use

To help reduce bacteria on the skin.


Warnings

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


Do not use

  • In or near the eyes. If contact occurs, rinse thoroughly with water.

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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

  • Apply to hands, rub together until dry.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP


RECENT MAJOR CHANGES SECTION

Dosage and Administration