OUT BACK PAIN RELIEF - tea tree oil and eucalyptus oil oil
Elmore Oil Company Pty Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredients

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

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

Purpose

Massage Oil to assist with relief of joint and muscle pain

Indication and Usage

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

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.

Warnings

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

Inactive Ingredients

Olive Oil (INCI name: Olea Europaea (Olive)

Vanilla (INCI Name: Vanillin)

Keep out of Reach of Children

Keep Out of Reach of Children

Product Label

Sachet

Bottle

OUT BACK PAIN RELIEF
tea tree oil and eucalyptus oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43979-550
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TEA TREE OIL (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G)	TEA TREE OIL	42.5 mg in 1 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	38.6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Olive Oil (UNII: 6UYK2W1W1E)

#	Item Code	Package Description
Packaging
1	NDC:43979-550-01	3 mL in 1 POUCH
2	NDC:43979-550-03	50 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/01/2012

Labeler - Elmore Oil Company Pty Ltd (755881968)