Label: THURSDAY PLANTATION- tea tree antiseptic cream cream

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

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Drug Label Information

Updated February 8, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:  melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

  • INDICATIONS & USAGE

    Uses:  minor burns, sunburn, minor skin irritations, scratches, dry skin, reduces inflammation

  • WARNINGS

    Warnings:

    For external use only

  • WHEN USING

    When using this product - 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 - in case of deep puncture wounds or serious burns, consult a doctor.

  • 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

    Directions - apply to the affected areas as often as needed.

  • DESCRIPTION

    Other Information - store below 86 degrees F.

    Integria Healthcare Australia Pty Ltd
    8 Clunies Ross Court, Eight Mile Plains
    QLD 4113 Australia
    www.thursdayplantation.com

    Distributed by:
    USA: Integria Healthcare (Australia) Pty Ltd.
    PO Box 4854, Eight Mile Plains
    QLD 4113 Australia
    USA Phone: 1-866-273-0377
  • INACTIVE INGREDIENT

    Inactive Ingredients:  Bentonite, Cetyl Alcohol, Glycerin, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Sodium Hydroxymethylglycinate, Sodium Stearoyl Lactylate, Water, Xantham Gum.

  • PRINCIPAL DISPLAY PANEL

    Thursday Plantation

    Tea Tree Antiseptic Cream

    Gently soothes and relieves

    Tea Tree Antiseptic Cream Label

  • INGREDIENTS AND APPEARANCE
    THURSDAY PLANTATION 
    tea tree antiseptic cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66141-643
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AUSTRALIAN TEA TREE OIL (UNII: VIF565UC2G) (AUSTRALIAN TEA TREE OIL - UNII:VIF565UC2G) AUSTRALIAN TEA TREE OIL5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66141-643-50100 g in 1 TUBE
    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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