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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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
Inactive Ingredients
Ingredient Name Strength
Olive Oil (UNII: 6UYK2W1W1E)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43979-550-01 3 mL in 1 POUCH
2 NDC:43979-550-03 50 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2012
Labeler - Elmore Oil Company Pty Ltd (755881968)

Revised: 9/2012
Document Id: 5109c9ab-837e-4705-ac81-83a552023a11
Set id: c0264e4c-2224-403e-8fd7-b796bb598375
Version: 1
Effective Time: 20120920
 
Elmore Oil Company Pty Ltd