KORA DAILY SAFE 80- hand sanitizer gel gel

KORA Daily Safe 80 by

Drug Labeling and Warnings

KORA Daily Safe 80 by is a Otc medication manufactured, distributed, or labeled by Kora Holdings LLC, Sellus. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

1. 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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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.

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.

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.

STOP USE

Stop use and ask a doctor if irritation, swelling or redness develops.

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

INGREDIENTS AND APPEARANCE

KORA DAILY SAFE 80 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75504-180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75504-180-11	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/20/2020

Labeler - Kora Holdings LLC (695692001)

Establishment
Name	Address	ID/FEI	Business Operations
Sellus		690026575	manufacture(75504-180)