Label: ELMORE OIL- tea tree oil and eucalyptus 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 18, 2013

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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 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.

  • 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


    50 ml label250 ml label

  • INGREDIENTS AND APPEARANCE
    ELMORE OIL 
    tea tree oil and eucalyptus oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43979-439
    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:43979-439-0350 mL in 1 BOTTLE, PLASTIC
    2NDC:43979-439-04250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2013
    Labeler - Elmore Oil Company Pty Ltd (755881968)