Label: COOL SENSE- propolis wax liquid

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

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Drug Label Information

Updated March 19, 2020

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  • ACTIVE INGREDIENT

    Propolis extract (total flavonoid 5%)

  • PURPOSE

    Can help the antimicrobial action in the mouth

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    3 times a day, spray 0.5ml (approx. 2 times) once orally

  • WARNINGS

    1. Those who are allergic to propolis should be careful about their intake, and those who have a specific or allergy should check their ingredients.
    2. If you experience any of the symptoms, please stop intake, consult a specialist or contact the customer service.
    3. Due to the nature of the raw materials, sediment may occur occasionally, but the quality is not abnormal.
    4. Check the expiration date before ingesting and follow the intake and intake method.
    5. Take care that the spray nozzle does not come in direct contact with your mouth and after spraying, clean and store the spray.
  • INACTIVE INGREDIENT

    water, gamma-cyclodextrin, xylitol, anhydrous dextrose, glucosyl steviol, citric acid monohydrate, codonopsis pilosula whole (concentrate), pear (concentrate) juice, chitosan, turmeric, artificial flavor

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    COOL SENSE 
    propolis wax liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73706-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF) PROPOLIS WAX1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73706-0001-22 in 1 CARTON03/17/2020
    1NDC:73706-0001-110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:73706-0001-32 in 1 BLISTER PACK03/17/2020
    2NDC:73706-0001-110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/17/2020
    Labeler - Bncare Agriculture Co., Ltd. (688206563)
    Registrant - Bncare Agriculture Co., Ltd. (688206563)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bncare Agriculture Co., Ltd.688206563manufacture(73706-0001)
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