Out Back Pain Relief

Manufacturer: Elmore Oil Company Pty Ltd
Effective date: 2012-09-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:33:10

Label at a glance#

ProductOut Back Pain Relief

Active ingredientTEA TREE OIL, EUCALYPTUS OIL

Label structure8 sections

Dosage and administration

Apply a small amount of Out Back Pain Relief 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#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml)

Eucalyptus Oil (E. Polybractea) - 3.86% (38.6 mg/ml)

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 Out Back Pain Relief 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Olive Oil (INCI name: Olea Europaea (Olive)

Vanilla (INCI Name: Vanillin)

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sachet

Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1312962	eucalyptus oil 3.86 % / tea tree oil 4.25 % Medicated Pad	PSN	1
1312962	Eucalyptus oil 38.6 MG/ML / tea tree oil 42.5 MG/ML Medicated Pad	SCD	1
1312962	eucalyptus oil 3.86 % / tea tree oil 4.25 % Medicated Pad	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43979-550-01	2019-11-13	C162847	48780-1	97449f38-d568-f6ea-e053-dbdaa90aa703	c0264e4c-2224-403e-8fd7-b796bb598375
43979-550-03	2019-11-13	C162847	48780-1	97449f38-d568-f6ea-e053-dbdaa90aa703	c0264e4c-2224-403e-8fd7-b796bb598375

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43979-550-01	Out Back Pain Relief	3 mL in 1 POUCH	OIL	3		1
43979-550-03	Out Back Pain Relief	50 mL in 1 BOTTLE	OIL	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43979-550	OUT BACK PAIN RELIEF (TEA TREE OIL AND EUCALYPTUS OIL) OIL [ELMORE OIL COMPANY PTY LTD]	1	Legacy NDC, 2 package rows	20121001_c0264e4c-2224-403e-8fd7-b796bb598375.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
EUCALYPTUS OIL	ACTIVE INGREDIENT	2R04ONI662	1
TEA TREE OIL	ACTIVE INGREDIENT	VIF565UC2G	1
EUCALYPTUS OIL	ACTIVE MOIETY	2R04ONI662	1
Tea Tree Oil	ACTIVE MOIETY	VIF565UC2G	1
Olive Oil	INACTIVE INGREDIENT	6UYK2W1W1E	1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Out Back Pain Relief
Tea Tree OIl and Eucalyptus Oil
TEA TREE OIL
EUCALYPTUS OIL
Olive Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43979-550	43979-550-01, 43979-550-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TEA TREE OIL	VIF565UC2G	ACTIB
EUCALYPTUS OIL	2R04ONI662	ACTIB
Olive Oil	6UYK2W1W1E	IACT

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Olive Oil	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Olive Oil	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
Olive Oil	OLIVE OIL	6UYK2W1W1E	CAPSULE / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Olive Oil	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Olive Oil	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5109c9ab-837e-4705-ac81-83a552023a11			c0264e4c-2224-403e-8fd7-b796bb598375	2012-09-20	Warnings	Exact identifier spl id: 5109c9ab-837e-4705-ac81-83a552023a11 spl set id: c0264e4c-2224-403e-8fd7-b796bb598375

Reported adverse events (FAERS/openFDA)#

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