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