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Out Back Pain Relief by Ultra Mix (Aust) Pty Ltd

Medically reviewed on April 9, 2018

Dosage form: oil
Ingredients: EUCALYPTUS OIL 38.6mg in 1mL, TEA TREE OIL 42.5mg in 1mL
Labeler: Ultra Mix (Aust) Pty Ltd
NDC Code: 69594-001

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.

Out Back Pain Relief

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

OUT BACK PAIN RELIEF 
eucalyptus oil and tea tree oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69594-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL38.6 mg  in 1 mL
TEA TREE OIL (TEA TREE OIL) TEA TREE OIL42.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL 
VANILLIN 
Packaging
#Item CodePackage Description
1NDC:69594-001-01300 mL in 1 PACKAGE
2NDC:69594-001-0250 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/16/2015
Labeler - Ultra Mix (Aust) Pty Ltd (752254649)
Establishment
NameAddressID/FEIOperations
Ultra Mix (Aust) Pty Ltd752254649manufacture(69594-001)

 
Ultra Mix (Aust) Pty Ltd

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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