Label: THURSDAY PLANTATION- tea tree antiseptic oil

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

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Drug Label Information

Updated February 22, 2010

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  • ACTIVE INGREDIENT

    Melaleuca Alternifolia (Tea Tree) Leaf Oil 100% ...... Antiseptic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only.

    Avoid contact with eyes, mouth, ears or 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.

  • PURPOSE

    Antiseptic

  • DOSAGE & ADMINISTRATION

    Directions:  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

    Thursday Plantation

    Australia's Original

    Tea Tree Antiseptic

    100% Pure

    Minimum 36% Terpinen-4-ol


    Distributed By:
    Integria Healthcare Australia
    Pty Ltd 8 Clunies Ross Court
    Eight Mile Plains, QLD 4113
    Australia
    www.thursdayplantation.com
    USA Phone: 1-866-273-0377
    Made in Australia

    Tea Tree Antiseptic Oil 25 ml

    Tea Tree Antiseptic Oil 10 ml

    Tea Tree Antiseptic Oil 10 ml Carton



  • INGREDIENTS AND APPEARANCE
    THURSDAY PLANTATION 
    tea tree antiseptic oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66141-640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL25 mL  in 25 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66141-640-5225 mL in 1 BOTTLE
    2NDC:66141-640-0110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2010
    Labeler - Integria Healthcare Ballina (750660367)
    Registrant - Integria Healthcare Australia (741396386)
    Establishment
    NameAddressID/FEIBusiness Operations
    Integria Healthcare Ballina750660367manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Integria Healthcare Australia741396386relabel
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