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Hand Sanitizer


SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured per guidance outlined in the final ruling of 21 CFR Part 310- Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 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):

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v))
  • Glycerin 98% (0.015% v/v).
  • Hydrogen peroxide 3% (0.04% v/v).
  • Sterile distilled water or boiled cold water (19.9% v/v).
  • Acrylates Copolymer (rheology modifier) (0.05% v/v).
  • Triethanolamine (pH neutralizer) (0.005% v/v).

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic


Purpose

Antiseptic, Hand Sanitizer


Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.


Warnings

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


Do not use

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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. These may be signs of a serious condition.


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 until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

Purified water USP, acrylates copolymer, hydrogen peroxide, glycerin, triethanolamine