FDA Label for Kora Daily Safe 80
View Indications, Usage & Precautions
Kora Daily Safe 80 Product Label
The following document was submitted to the FDA by the labeler of this product Kora Holdings Llc. 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
For hand sanitizer to reduce microorganisms that potentially can cause diseases. Recommended for repeated 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
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
Stop use and ask a doctor if irritation, swelling or redness develops.
Otc - Keep Out Of Reach Of Children
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
Package Label - Principal Display Panel
500 mL NDC: 75504-080-01
* Please review the disclaimer below.