Label: ITCHY BITTEN- eucalyptus peppermint oil gel

  • 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

    Eucalyptus Oil .17%

    Peppermint Oil.17%

  • PURPOSE

    Temporarily relieves itching and discomfort associated with irritation, inflammation, and rashes due to insect bites, stings, poison ivy, oak and sumac

  • WARNINGS

    For external use only

    Do not use other than as directed

    When using this product

    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or broken skin
  • INDICATIONS & USAGE

    Temporarily relieves itching and discomfort associated with irritation, inflammation, and rashes due to insect bites, stings, poison ivy, oak and sumac​

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • INACTIVE INGREDIENT

    Organic Extra Virgin Olive Oil, Sweet Almond Oil, Organic Wild Harvested Chickweed Oil, Beeswax, Organic Marigold Oil, French Lavender Essential Oil, Spanish Rosemary Essential Oil, Natural Vitamin E.

  • 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
  • PRINCIPAL DISPLAY PANEL

    Itchy

  • INGREDIENTS AND APPEARANCE
    ITCHY BITTEN 
    eucalyptus peppermint oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71157-0018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL3 g  in 90 mL
    CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB) (CORYMBIA CITRIODORA LEAF OIL - UNII:M63U6N96EB) CORYMBIA CITRIODORA LEAF OIL3 g  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    STELLARIA MEDIA LEAF (UNII: E6M924345X)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71157-0018-190 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(71157-0018)
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