ITCHY BITTEN (EUCALYPTUS PEPPERMINT OIL) GEL [KELADA CREATIVE GROUP]

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ITCHY BITTEN (EUCALYPTUS PEPPERMINT OIL) GEL [KELADA CREATIVE GROUP]
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NDC 71157-0018-1
Set ID 451e52eb-8588-6127-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Kelada Creative Group
Generic Name
Product Class
Product Number
Application Number
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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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