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
Antimicrobial
Use
Dry Hand Sanitizer helps prevent the development of bacteria on the skin.
It moisturizes and softens the hand skin with the sweet fragrance.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
- for children under 36 months.
OTC - WHEN USING SECTION
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
For children: need to be supervised by adults when using it.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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 in dry and cool place
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
RECENT MAJOR CHANGES SECTION
Update Uses: from template to label description.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep our of reach of children