FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Hanul Co.,ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- 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.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
to decrease bacteria on the skin that can cause disease.
Warnings
For external use only: hands. Flammable. Keep away from fire or flame
Otc - When Using
When using the product keep out of eyes. In case of contact with eyes flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Place enough product to hands to cover all surface
Rub hands together until dry
Not recommended for infants
Other Information
do not store above105°F/40°C
May discolor some fabrics
Harmful to wood finishes and plastics
Inactive Ingredients
Water. Glycerin, Hydrogen peroxide, Carbomer, Aminomethyl Propanol, Fragrance
Package Label - Principal Display Panel
500 mL NDC: 75214-502-50
Rico
Hand sanitizer
non-sterile solution
80% alcohol antiseptic
kill 99.9% germs of common illness-causing germs
* Please review the disclaimer below.