OUT BACK PAIN RELIEF- eucalyptus oil and tea tree 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 Ultra Mix (Aust) Pty Ltd , Ultra Mix (Aust) Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actives

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

Inactives

Olive oil and Vanilin

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 Elmore 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.

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

Keep out of reach from children.

Keetp out of reach of children

Keetp out of reach of children

Product label

INGREDIENTS AND APPEARANCE

OUT BACK PAIN RELIEF 
eucalyptus oil and tea tree oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69594-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69594-001-01	300 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/16/2015
2	NDC: 69594-001-02	50 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/16/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/16/2015

Labeler - Ultra Mix (Aust) Pty Ltd (752254649)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Mix (Aust) Pty Ltd		752254649	manufacture(69594-001)