Label: ADEA GARGLE- citric acid, sodium hydrogen carbonate, xylitol tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 26, 2018

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  • ACTIVE INGREDIENT

    CITRIC ACID, SODIUM HYDROGEN CARBONATE, XYLITOL

  • PURPOSE

    For oral care: Tooth whitening, removing bad breath, preventing tooth decay, preventing gingivitis and tartar formation, plaque removal, oral cleansing

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Put a tablet of Adea Gargle in your mouth and chew or melt according to your preference.

    When foaming starts, please gaggle for more than 30 seconds so that every corner of the mouth can reach Adea Gaggle.

    When the gaggle is over, spit or swallow the bubbles.

  • WARNINGS

    Airtight container

    Storage at room temperature

    Please close the lid tightly after opening.

    Avoid direct sunlight and store in a cool place.

    For specific or unusual constitution, allergic constitution, please use after checking ingredients.

  • INACTIVE INGREDIENT

    GLUCOSE, MENTHOL, MAGNESIUM STEARATE, ASPARTAME, SUCRALOSE

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ADEA GARGLE 
    citric acid, sodium hydrogen carbonate, xylitol tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72191-0100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE36.2 g  in 100 mg
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL5 g  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeBULLETSize17mm
    FlavorPEPPERMINTImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72191-0100-1850 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2018
    Labeler - K2resource co., ltd. (694503238)
    Registrant - K2resource co., ltd. (694503238)
    Establishment
    NameAddressID/FEIBusiness Operations
    K2resource co., ltd.694503238manufacture(72191-0100)
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