FDA.reportPublic FDA data

Zoono Ultra Hand Sanitizer

Manufacturer
Zoono Holdings USA, LLC | Holly Oak Chemical, Inc | Action-Pak Inc
Effective date
2021-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:31

Label at a glance#

ProductZoono Ultra Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

For personal hand sanitizing and to reduce bacteria on the skin. Recommended for repeated use.

Dosage and administration

Apply liberally to the hands and gently rub until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alchol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For personal hand sanitizing and to reduce bacteria on the skin.

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Do not use in the eyes.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of eye contact flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation and redness develop.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Cener right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to the hands and gently rub until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium chloride, Fragrance, Polysorbate, Silica Complex 3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Water

Questions or Comments?

OTC - QUESTIONS SECTION

Telephone: 1-844-966-6687

Monday through Friday

8:00am till 5:00pm EST

Primary Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

typical for all sizestypical for all sizes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69221-501-112023-01-30C16284748780-1f386c649-9dfc-0266-e053-dadaa90a7c1aZoono Ultra Hand Sanitizer
69221-501-132023-01-30C16284748780-1f386c649-9dfc-0266-e053-dadaa90a7c1aZoono Ultra Hand Sanitizer
69221-501-152023-01-30C16284748780-1f386c649-9dfc-0266-e053-dadaa90a7c1aZoono Ultra Hand Sanitizer
69221-501-162023-01-30C16284748780-1f386c649-9dfc-0266-e053-dadaa90a7c1aZoono Ultra Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69221-501-11Zoono Ultra Hand Sanitizer50 mL in 1 BOTTLELIQUID503
69221-501-13Zoono Ultra Hand Sanitizer150 mL in 1 BOTTLELIQUID1503
69221-501-15Zoono Ultra Hand Sanitizer1000 mL in 1 BOTTLELIQUID10003
69221-501-16Zoono Ultra Hand Sanitizer3785 mL in 1 BOTTLELIQUID37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69221-501ZOONO ULTRA HAND SANITIZER (ALCOHOL) LIQUID [ZOONO HOLDINGS USA, LLC]3Current NDC, Legacy NDC, 4 package rows20211209_b4df8965-99b7-4349-e053-2a95a90a5e3c.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69221-50169221-501-13, 69221-501-11, 69221-501-15, 69221-501-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoono Ultra Hand SanitizerALCOHOLZoono Holdings USA, LLC3dbb255c-1256-66a7-e054-00144ff8d46c2026-07-31WarningsExact identifier
ndc (product): 69221-501
d2a41ff8-4b94-0854-e053-2a95a90a3ba5b4df8965-99b7-4349-e053-2a95a90a5e3c2021-12-08WarningsExact identifier
spl id: d2a41ff8-4b94-0854-e053-2a95a90a3ba5
spl set id: b4df8965-99b7-4349-e053-2a95a90a5e3c

Reported adverse events (FAERS/openFDA)#

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