ZURI 80% TOPICAL SOLUTION HAND SANITIZER- alcohol liquid 
Kaizen Global Partners Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ZuRI™ Hand Sanitizer

Drug Facts

Active Ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

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

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 hand 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 15-30 C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients: glycerin, hydrogen peroxide, purified water USP

80% Topical Solution

Alcohol Antiseptic

Kaizen Global Partners, LLC

36718 Detroid Rd.

Avon, OH 44011

Packaging

IMAGE

ZURI 80% TOPICAL SOLUTION HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80347-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80347-080-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
2NDC:80347-080-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
3NDC:80347-080-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
4NDC:80347-080-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
5NDC:80347-080-16473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
6NDC:80347-080-103785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/25/2020
Labeler - Kaizen Global Partners Llc (052778124)

Revised: 9/2020
Document Id: 630244d2-d847-4c26-8a2d-9686a7b7f344
Set id: 97fdbad6-6c3e-496a-b1a5-9faa85d0af5b
Version: 1
Effective Time: 20200925
 
Kaizen Global Partners Llc