FDA.reportPublic FDA data

Out Back Pain Relief

Manufacturer
Ultra Mix (Aust) Pty Ltd
Effective date
2016-04-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:45:45

Label at a glance#

ProductOut Back Pain Relief
Active ingredientEUCALYPTUS OIL, TEA TREE OIL
Label structure8 sections

Dosage and administration

Apply a small amount of Elmore Oil to the pain affected area and gently massage in until fully absorbed. Use before and after activity for maximum relief.

Label contents#

Full prescribing information#

Actives

OTC - ACTIVE INGREDIENT SECTION

Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml)
Eucalyptus Oil (Eucalyptus radiata) - 3.86% (38.6 mg/ml)

Inactives

INACTIVE INGREDIENT SECTION

Olive oil and Vanilin

Purpose

OTC - PURPOSE SECTION

Massage Oil to assist with relief of joint and muscle pain

Indication and Usage

INDICATIONS & USAGE SECTION

Temporary relief of joint and muscle pain, including lower back pain

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply a small amount of Elmore Oil to the pain affected area and gently massage in until fully absorbed. Use before and after activity for maximum relief.

Warnings

WARNINGS SECTION

For external use only.


In case of accidental ingestion, get medical help or contact a Poisons Control Center right away.

If pregnant or breast feeding ask health care professional before use.

Keep out of reach from children.

Keetp out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keetp out of reach of children

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

outabck-pain-reliefoutabck-pain-relief

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69594-001-012020-01-31C16284748780-19d75b9d1-2625-f424-e053-dadaa90a57ceOut Back Pain Relief
69594-001-022020-01-31C16284748780-19d75b9d1-2625-f424-e053-dadaa90a57ceOut Back Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69594-001-01Out Back Pain Relief300 mL in 1 PACKAGEOIL3004
69594-001-02Out Back Pain Relief50 mL in 1 PACKAGEOIL504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69594-001OUT BACK PAIN RELIEF (EUCALYPTUS OIL AND TEA TREE OIL) OIL [ULTRA MIX (AUST) PTY LTD ]4Legacy NDC, 2 package rows20160419_b4bf7b71-bf23-4d3d-8111-35a4960174be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EUCALYPTUS OILACTIVE INGREDIENT2R04ONI6621
TEA TREE OILACTIVE INGREDIENTVIF565UC2G1
EUCALYPTUS OILACTIVE MOIETY2R04ONI6621
TEA TREE OILACTIVE MOIETYVIF565UC2G1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
VANILLININACTIVE INGREDIENTCHI530446X1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69594-00169594-001-01, 69594-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662ACTIB
TEA TREE OILVIF565UC2GACTIB
OLIVE OIL6UYK2W1W1EIACT
VANILLINCHI530446XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
VANILLINVANILLINCHI530446XTABLET, CHEWABLE / ORAL2.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XOINTMENT / TOPICALNAExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET, COATED / ORAL65.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET, ORALLY DISINTEGRATING / ORAL0.26 mgExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XELIXIR / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XLIQUID / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET, FILM COATED, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XPOWDER, FOR SUSPENSION / ORAL2 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XSUSPENSION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
VANILLINVANILLINCHI530446XSOLUTION / ORAL2.5 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
VANILLINVANILLINCHI530446XSYRUP / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
VANILLINVANILLINCHI530446XTABLET, EXTENDED RELEASE / ORAL3.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates

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
990d6070-e695-4011-8e1f-c4857db460eeb4bf7b71-bf23-4d3d-8111-35a4960174be2016-04-08WarningsExact identifier
spl id: 990d6070-e695-4011-8e1f-c4857db460ee
spl set id: b4bf7b71-bf23-4d3d-8111-35a4960174be

Reported adverse events (FAERS/openFDA)#

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