FDA.reportPublic FDA data

OZ NATURALS Antiseptic Gel Handsanitizer

Manufacturer
OZ Naturals LLC
Effective date
2021-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:26

Label at a glance#

ProductOZ NATURALS Antiseptic Gel Handsanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Adults and children over 2 years Supervise children when they use this product For occasional and personal domestic use Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Label contents#

Full prescribing information#

PURPOSE

OTC - PURPOSE SECTION

Antispetic Skin Cleanser

Use

INDICATIONS & USAGE SECTION

Antiseptic skin cleanser to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

DIRECTIONS FOR USE:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years
Supervise children when they use this product
For occasional and personal domestic use
Rub thoroughly into hands for at least 30 seconds. Allow to dry.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%p/p

WARNINGS:

WARNINGS SECTION

For external use only

• When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water

• Stop use and consult a health care professional if irritation develops

• Keep out of reach of children

• If swallowed, call a poison control center or get medical help right away

• Flammable

• Keep away from flames or heat source

• Avoid temperature over 43°C (110°F)

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Glycerin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Citrus Paradisi (Grapefruit) Peel Oil, Carbomer, Triethanolamine

Distributed by OZNaturals®

HOW SUPPLIED SECTION

319 Clematis St. Ste. 700,
West Palm Beach, FL 33401

MADE IN CANADA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OZNATURALS Antiseptic Gel Hand Sanitizer

KILLS HARMFUL BACTERIA AND GERMS

1 Oz Sanitizer Label1 Oz Sanitizer Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75592-201-012022-07-29C16284748780-1e4f33bdf-9cd7-d8a0-e053-dadaa90a6e4eOZ NATURALS Antiseptic Gel Handsanitizer
75592-201-022022-07-29C16284748780-1e4f33bdf-9cd7-d8a0-e053-dadaa90a6e4eOZ NATURALS Antiseptic Gel Handsanitizer
75592-201-032022-07-29C16284748780-1e4f33bdf-9cd7-d8a0-e053-dadaa90a6e4eOZ NATURALS Antiseptic Gel Handsanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75592-201-01OZ NATURALS Antiseptic Gel Handsanitizer1 in 1 BOXGEL14
75592-201-01OZ NATURALS Antiseptic Gel Handsanitizer30 mL in 1 BOTTLEGEL304
75592-201-02OZ NATURALS Antiseptic Gel Handsanitizer120 mL in 1 BOTTLEGEL1204
75592-201-02OZ NATURALS Antiseptic Gel Handsanitizer1 in 1 BOXGEL14
75592-201-03OZ NATURALS Antiseptic Gel Handsanitizer1 in 1 BOXGEL14
75592-201-03OZ NATURALS Antiseptic Gel Handsanitizer475 mL in 1 BOTTLEGEL4754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75592-201OZ NATURALS ANTISEPTIC GEL HANDSANITIZER (ALCOHOL) GEL [OZ NATURALS LLC]4Legacy NDC, 6 package rows20211207_a3b31e87-c6fc-e85b-e053-2a95a90a37a3.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75592-20175592-201-01, 75592-201-02, 75592-201-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRUS PARADISI FRUIT OIL6A7N43E0OJIACT
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
TRIETHANOLAMINE ISOSTEARATET8OTU5ECY5IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d27c902e-b868-559c-e053-2a95a90ad25fa3b31e87-c6fc-e85b-e053-2a95a90a37a32021-12-06WarningsExact identifier
spl id: d27c902e-b868-559c-e053-2a95a90ad25f
spl set id: a3b31e87-c6fc-e85b-e053-2a95a90a37a3

Reported adverse events (FAERS/openFDA)#

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