FDA.reportPublic FDA data

ZuRI 70.5% Topical Solution Hand Sanitizer

Manufacturer
Kaizen Global Partners Llc
Effective date
2020-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:23

Label at a glance#

ProductZuRI 70.5% Topical Solution Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

- 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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70.5% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2399560ethanol 70.5 % Topical SolutionPSN1
2399560ethanol 0.705 ML/ML Topical SolutionSCD1
2399560ethanol 70.5 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80347-070-022022-01-28C16284748780-1d6a99b39-4923-a426-e053-dadaa90af4c2ZuRI™ Hand Sanitizer
80347-070-042022-01-28C16284748780-1d6a99b39-4923-a426-e053-dadaa90af4c2ZuRI™ Hand Sanitizer
80347-070-082022-01-28C16284748780-1d6a99b39-4923-a426-e053-dadaa90af4c2ZuRI™ Hand Sanitizer
80347-070-102022-01-28C16284748780-1d6a99b39-4923-a426-e053-dadaa90af4c2ZuRI™ Hand Sanitizer
80347-070-122022-01-28C16284748780-1d6a99b39-4923-a426-e053-dadaa90af4c2ZuRI™ Hand Sanitizer
80347-070-162022-01-28C16284748780-1d6a99b39-4923-a426-e053-dadaa90af4c2ZuRI™ Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80347-070-02ZuRI 70.5% Topical Solution Hand Sanitizer59 mL in 1 BOTTLEGEL591
80347-070-04ZuRI 70.5% Topical Solution Hand Sanitizer118 mL in 1 BOTTLEGEL1181
80347-070-08ZuRI 70.5% Topical Solution Hand Sanitizer236 mL in 1 BOTTLEGEL2361
80347-070-10ZuRI 70.5% Topical Solution Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
80347-070-12ZuRI 70.5% Topical Solution Hand Sanitizer354 mL in 1 BOTTLEGEL3541
80347-070-16ZuRI 70.5% Topical Solution Hand Sanitizer473.17 mL in 1 BOTTLEGEL473.171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80347-070ZURI 70.5% TOPICAL SOLUTION HAND SANITIZER (ALCOHOL) GEL [KAIZEN GLOBAL PARTNERS LLC]1Legacy NDC, 6 package rows20201010_e084d68d-1f46-4812-a30e-7bce3758e401.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80347-07080347-070-02, 80347-070-04, 80347-070-08, 80347-070-12, 80347-070-16, 80347-070-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a1d3b316-cd9c-462e-8067-0a7d07cc1f80e084d68d-1f46-4812-a30e-7bce3758e4012020-09-24WarningsExact identifier
spl id: a1d3b316-cd9c-462e-8067-0a7d07cc1f80
spl set id: e084d68d-1f46-4812-a30e-7bce3758e401

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.