FDA.reportPublic FDA data

Australian Gold Lidocaine ALOE GEL

Manufacturer
Prime Enterprises, Inc.
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:11:03

Label at a glance#

ProductAustralian Gold Aloe Gel with Lidocaine
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Adults and children 2 years of age and older:     Apply to afftected area not more than 3 to 4 times daily. Children under 2 years of age:     consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride(0.5 %)

Purpose

OTC - PURPOSE SECTION

External Analgesic

Indications

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor

Do not use in large quantities, particularly over raw surfaces or bliseterd areas

Keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.

OTHER SAFETY INFORMATION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with eyes.

OTC - STOP USE SECTION

If conditions worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older:

    Apply to afftected area not more than 3 to 4 times daily.

  • Children under 2 years of age:

    consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, Blue 1, Caprylyl Glycol, Carbomer, Citrus Limon (Lemon) Peel Extract, Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Hexylene Glycol, Mentha Viridis (Spearmint) Leaf Oil, Panthenol, PEG-60 Lanolin, Phenoxyethanol, Pollen Extract, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Symphytum Officinale (Comfrey) Leaf Extract, Tilia Cordata Flower Extract, Tocopheryl Acetate, Water

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-LIV-GOLD (546-4653)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0327-42023-01-30C16284748780-1f386c649-e897-0266-e053-dadaa90a7c1aAustralian Gold Lidocaine ALOE GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0327-4Australian GoldAloe Gel with Lidocaine237 mL in 1 BOTTLEGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0327AUSTRALIAN GOLD ALOE GEL WITH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES, INC.]1Legacy NDC, 1 package rows20200513_a575bf5f-e3cd-1ff5-e053-2995a90a5cb3.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-032758443-0327-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
ALOE VERA LEAFZY81Z83H0XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
SCOTCH SPEARMINT OILI5T0098W81IACT
PEG-60 LANOLINK2OI1D27ETIACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
BEE POLLEN3729L8MA2CIACT
COMFREY LEAFDG4F8T839XIACT
TILIA CORDATA FLOWERCFN6G1F6YKIACT
ALPHA-TOCOPHERYLQUINONEZO763K43XRIACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE98PI200987ACTIB
CARBOMER 1342809Y72KV36IACT

Source Document#

Source XML · Source PDF

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
a575bf5f-e3ce-1ff5-e053-2995a90a5cb3a575bf5f-e3cd-1ff5-e053-2995a90a5cb32020-05-12WarningsExact identifier
spl id: a575bf5f-e3ce-1ff5-e053-2995a90a5cb3
spl set id: a575bf5f-e3cd-1ff5-e053-2995a90a5cb3

Reported adverse events (FAERS/openFDA)#

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