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

  • Label RSS
  • NDC Code(s): 43979-550-01, 43979-550-03
  • Packager: Elmore Oil Company Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • Active Ingredients

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

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

    Massage Oil to assist with relief of joint and muscle pain

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  • Indication and Usage

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

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  • 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.

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  • Warnings

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

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  • Inactive Ingredients

    Olive Oil (INCI name: Olea Europaea (Olive)

    Vanilla (INCI Name: Vanillin)

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  • Keep out of Reach of Children

    Keep Out of Reach of Children
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  • Product Label
  • INGREDIENTS AND APPEARANCE
    OUT BACK PAIN RELIEF 
    tea tree oil and eucalyptus oil oil
    Product Information
    Product Type HUMAN OTC DRUG LABEL 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 (Tea Tree Oil) TEA TREE OIL 42.5 mg  in 1 mL
    EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL 38.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Olive Oil  
    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)
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