FDA.reportPublic FDA data

Australian Gold

Manufacturer
Prime Enterprises
Effective date
2022-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:04:26

Label at a glance#

ProductAustralian Gold Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

To decrease bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

Directions Wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Storage and handling

Other information do not store above 104ºF. may discolor some fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • To decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

Flammable

SPL UNCLASSIFIED SECTION

Flammable. Keep away from heat or flame.

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

​

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

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
  • for children under 6, use only under adult supervision
  • not recommended for infants

STORAGE AND HANDLING SECTION

Other information

  • do not store above 104ºF.
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Glycerin, Isopropyl Myristate, Tocopherol, Water

OTC - QUESTIONS SECTION

Call 1-855-548-4653

Australian Gold Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display LabelPrinciple Display LabelPrinciple Display Label

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
58443-050458443-0504-3

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
TOCOPHEROLR0ZB2556P8IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CARBOMER 934Z135WT9208IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
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
dbe949c1-deaa-54f3-e053-2a95a90a6a5dd57e4b6c-0b22-7ab2-e053-2995a90a77e42022-04-05WarningsExact identifier
spl id: dbe949c1-deaa-54f3-e053-2a95a90a6a5d
spl set id: d57e4b6c-0b22-7ab2-e053-2995a90a77e4

Reported adverse events (FAERS/openFDA)#

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