Label: TEA TREE ANTISEPTIC- melaleuca alternifolia ointment

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 17, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!