TEA TREE ANTISEPTIC (MELALEUCA ALTERNIFOLIA) OINTMENT [INTEGRIA HEALTHCARE US INC.]

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TEA TREE ANTISEPTIC (MELALEUCA ALTERNIFOLIA) OINTMENT [INTEGRIA HEALTHCARE US INC.]
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NDC 51257-644-01
Set ID 9534eb1d-89a7-4922-a121-742aa5418416
Category HUMAN OTC DRUG LABEL
Packager Integria Healthcare US Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection

  • WARNINGS

    For external use only

  • ASK DOCTOR

    In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

  • STOP USE

    Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs.

  • 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

    • clean the affected area
    • apply small amount two or three times a day
    • may be covered with a sterile bandage
  • STORAGE AND HANDLING

    store below 86 degrees F

  • INACTIVE INGREDIENT

    Beeswax, Canola Oil, Copernicia Cerifera (Carnauba) Wax, Macadamia Integrifolia Seed Oil, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    Tea Tree Antiseptic Ointment Label

  • INGREDIENTS AND APPEARANCE
    TEA TREE ANTISEPTIC 
    melaleuca alternifolia ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-644
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL2.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51257-644-0150 g in 1 JAR
    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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