Label: HOO GARGLE (MOUTHWASH)- xylitol liquid

  • NDC Code(s): 81840-1001-1, 81840-1001-2, 81840-1001-3
  • Packager: MIKO CO LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 24, 2022

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  • ACTIVE INGREDIENT

    sodium fluoride

  • INACTIVE INGREDIENT

    menthol

    xylitol

    Sodium acetate

    Allanine
    Acetic acid
    Propolis
    Chitosan
    Green tea extract

    Stevia
    Cyclodextrin
    Benzoic acid
    Red ginsengs extract

    Caramel
    Grapefruit seed extract

    Maple flavor
    Apple spearmint flavor

    Purified Water

  • PURPOSE

    dental care

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    1. Put one cup in mouth.

    2. Gargle for 30 sec ~ 1 minute

    3. Spit it out.

    5. Rinse with water.

  • WARNINGS

    Be careful not to swallow it, and rinse your mouth thoroughly after use.

  • DOSAGE & ADMINISTRATION

    dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HOO GARGLE (MOUTHWASH) 
    xylitol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81840-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81840-1001-3100 in 1 PACKAGE04/20/2021
    1NDC:81840-1001-230 in 1 PACKAGE
    1NDC:81840-1001-110 mL in 1 CUP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/20/2021
    Labeler - MIKO CO LTD (689973854)
    Registrant - MIKO CO LTD (689973854)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIKO CO LTD689973854manufacture(81840-1001)
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