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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 20, 2012

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  • 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


    Sachet


    Bottle

  • INGREDIENTS AND APPEARANCE
    OUT BACK PAIN RELIEF 
    tea tree oil and eucalyptus oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43979-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G) TEA TREE OIL42.5 mg  in 1 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL38.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Olive Oil (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43979-550-013 mL in 1 POUCH
    2NDC:43979-550-0350 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2012
    Labeler - Elmore Oil Company Pty Ltd (755881968)
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