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)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
For hand sanitizer to reduce microorganisms that potentially can cause diseases. Recommended for repeated use.
Use
-Put enough product in your palm to cover hands and rub hands together briskly until dry.
-Children under 6 years of age should be supervised when using.
Warnings
For external use on hands only. Flammable. Keep away from fire or flame
Do not use
- in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
OTC - WHEN USING SECTION
When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation, swelling or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation, swelling or redness develops.
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 immediately.
Directions
- Put enough product in your palm to cover hands and rub hands together briskly until dry.
- Children under 6 years of age should be supervised when using.
Other information
- Store below 110°F (43°C)
Inactive ingredients
glycerin (Glycerol), hydrogen peroxide, Sterile Distilled Water