Label: TEA TREE OIL liquid

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

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Drug Label Information

Updated January 17, 2020

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  • Active ingredient

    MELALEUCA ALTERNIFOLIA LEAF 100%

  • Purpose

    Antiseptic

  • Uses

    treats minor cuts,minor bums,scrapes,abrasions,insect bites and stings

  • Warnings

    For External use only.
    avoid contact wih eyes,mouth,ears and other sensitive areas of the body.if contact occurs,rinse thoroughly with water.

    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 seallowed ,get medical help or contact a Poison Control Center right away.

  • Directions

    apply to the affected area,use sparingly by drop,children under 12 years of age :consult a doctor.

  • INACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    TEA TREE OIL 
    tea tree oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70876-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) (MELALEUCA ALTERNIFOLIA LEAF - UNII:G43C57162K) MELALEUCA ALTERNIFOLIA LEAF0.95 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70876-002-011 in 1 BOX08/19/2016
    110 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/18/2016
    Labeler - Fujian Meigulin Bio-Technique Co., Ltd. (529340399)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fujian Meigulin Bio-Technique Co., Ltd.529340399manufacture(70876-002)
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