ZURI 70.5% TOPICAL SOLUTION HAND SANITIZER- alcohol gel

ZuRI 70.5% Topical Solution Hand Sanitizer by

Drug Labeling and Warnings

ZuRI 70.5% Topical Solution Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kaizen Global Partners Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient(s)

Alcohol 70.5% v/v

Purpose

Antiseptic

INDICATIONS & USAGE

Uses(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

Warnings For external use only. Flammable. Keep away from heat or flame.

Do not use

- On 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 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.

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 INGREDIENT

Inactive Ingredients: glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

70.5% Topical Solution

Alcohol Antiseptic

Kaizen Global Partners, LLC

36718 Detroit Rd.

Avon, OH 44011

Packaging

INGREDIENTS AND APPEARANCE

ZURI 70.5% TOPICAL SOLUTION HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80347-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80347-070-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020
2	NDC: 80347-070-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020
3	NDC: 80347-070-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020
4	NDC: 80347-070-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020
5	NDC: 80347-070-16	473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020
6	NDC: 80347-070-10	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/25/2020

Labeler - Kaizen Global Partners Llc (052778124)