Label: TEA TREE ANTISEPTIC- melaleuca alternifolia oil

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

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Drug Label Information

Updated March 17, 2011

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  • ACTIVE INGREDIENT

    Melaleuca Alternifolia (Tea Tree) Leaf Oil 100%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    treats minor cuts, minor burns, scrapes, abrasions, insect bites and stings.

  • WARNINGS

    For external use only

    • avoid contact with eyes, mouth, ears and other sensitive areas of the body
    • if contact occurs, rinse thoroughly with water
  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve within 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    • apply to the affected area
    • use sparingly by drop
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    store below 86 degrees F

  • PRINCIPAL DISPLAY PANEL

    Tea Tree Oil Antiseptic

    100% Pure

    Minimum 36% Terpinen-4-ol

    Tea Tree Oil 15 mL Carton

    Tea Tree Oil 15 mL Label



  • INACTIVE INGREDIENT

    None.

  • INGREDIENTS AND APPEARANCE
    TEA TREE ANTISEPTIC 
    melaleuca alternifolia oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL15 mL  in 15 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51257-640-0110 mL in 1 BOTTLE
    2NDC:51257-640-0215 mL in 1 BOTTLE
    3NDC:51257-640-0325 mL in 1 BOTTLE
    4NDC:51257-640-0450 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2011
    Labeler - Integria Healthcare US Inc. (962379454)
    Registrant - Integria Healthcare US Inc. (962379454)
    Establishment
    NameAddressID/FEIBusiness Operations
    Integria Healthcare (Ballina) 750660367manufacture
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