OUT BACK PAIN RELIEF- tea tree oil and eucalyptus oil oil

Out Back Pain Relief by

Drug Labeling and Warnings

Out Back Pain Relief by is a Otc medication manufactured, distributed, or labeled by Elmore Oil Company Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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)