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

  • 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

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 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)
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