Label: SCRATCHED- tea tree oil oil

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 16, 2017

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  • ACTIVE INGREDIENT

    Tea Tree Oil 4.9%

  • PURPOSE

    First aid to help prevent infection and for temporary relief of discomfort from minor cuts and scratches

  • WARNINGS

    For external use only

    Do not use other than as directed

    When using this product

    • avoid contact with eyes and mucous membranes
    • consult with doctor before applying on post-surgical sites
  • INDICATIONS & USAGE

    First aid to help prevent infection and for temporary relief of discomfort from minor cuts and scratches​

  • DOSAGE & ADMINISTRATION

    Adults and children 3 years of age and older; lightly apply to affected area not more than 5 times daily

    Children under 3 years of age; ask 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.

  • INACTIVE INGREDIENT

    Organic sunflower oil, Beeswax, Organic extra virgin olive oil, Organic comfrey leaf, Kaolin clay, Spanish Rosemary essential oil, Natural Vitamin E

  • PRINCIPAL DISPLAY PANEL

    Scratched

  • INGREDIENTS AND APPEARANCE
    SCRATCHED 
    tea tree oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71157-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL1089 g  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71157-0021-190 mL in 1 CAN; Type 0: Not a Combination Product01/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/09/2017
    Labeler - Kelada Creative Group (014340121)
    Registrant - Kelada Creative Group (014340121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kelada Creative Group014340121manufacture(71157-0021)
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