Active Ingredients & back label [OTC - ACTIVE INGREDIENT SECTION]
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 Ingredients & back label [OTC - ACTIVE INGREDIENT SECTION]
Alcohol 80% v/v. Purpose: Antiseptic
COMPOSITION: ethanol or isopropanol, glycerol and hydrogen peroxide. WHO-RECOMMENDED HANDRUB FORMULATION: Whitedog (ethanol) – 80% volume/volume, Glycerol (1.45% v/v), Hydrogen peroxide (.125% v/v), boiled rainwater. FOR EXTERNAL USE ONLY: Avoid contact with eyes. Keep out of reach of children. FLAMMABLE: Keep away from flame and heat. USE: Apply a palmful of alcohol-based hand rub and cover all surfaces of the hands. Rub hands until dry.
Purpose
Use(s)
Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.
Use
Uses: Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Directions:
-Place enough product on hands to cover all surfaces. Rub hands together until dry.
-Supervise children under 6 years of age when using this product to avoid swallowing.
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
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.
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 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. 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 together 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
glycerin, hydrogen peroxide, purified water USP
RECENT MAJOR CHANGES SECTION
Active Ingredient Section
Purpose Section
Principal Display Panel and Front Label