FDA.reportPublic FDA data

Ozcare Antiseptic Hand Sanitizer Spray

Manufacturer
Reed Holdings Australia, Pty. Ltd.
Effective date
2020-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:30

Label at a glance#

ProductOzcare Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • for hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only
Flammable, keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

  • in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • if condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Extract, Disodium EDTA, Eucalyptus Oil, Glycerin, Lavender Oil, Tocopherol Acetate, Triethanolamine, Water

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-888-0776

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN1
1041849ethanol 0.7 ML/ML Topical SpraySCD1
1041849ethanol 70 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75584-001-012022-01-28C16284748780-1d6a99b39-aba5-a426-e053-dadaa90af4c2Ozcare Antiseptic Hand Sanitizer Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75584-001-01Ozcare Antiseptic Hand Sanitizer250 mL in 1 BOTTLESPRAY2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75584-001OZCARE ANTISEPTIC HAND SANITIZER (ALCOHOL) SPRAY [REED HOLDINGS AUSTRALIA, PTY. LTD.]1Legacy NDC, 1 package rows20200725_8f51ce44-64ad-4045-af1e-404bd3b5f9df.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75584-00175584-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
LAVENDER OILZBP1YXW0H8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ab219e08-bc70-eeaf-e053-2a95a90a52d68f51ce44-64ad-4045-af1e-404bd3b5f9df2020-07-23WarningsExact identifier
spl id: ab219e08-bc70-eeaf-e053-2a95a90a52d6
spl set id: 8f51ce44-64ad-4045-af1e-404bd3b5f9df

Reported adverse events (FAERS/openFDA)#

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