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

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

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.

Drug Label Information

Updated April 8, 2016

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  • 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

    outabck-pain-relief

  • INGREDIENTS AND APPEARANCE
    OUT BACK PAIN RELIEF 
    eucalyptus oil and tea tree oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69594-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL38.6 mg  in 1 mL
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL42.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69594-001-01300 mL in 1 PACKAGE; Type 0: Not a Combination Product02/16/2015
    2NDC:69594-001-0250 mL in 1 PACKAGE; Type 0: Not a Combination Product02/16/2015
    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/FEIBusiness Operations
    Ultra Mix (Aust) Pty Ltd752254649manufacture(69594-001)
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