Label: DENTI WHOO BUBBLE CONCENTRATED GARGLE- cetylpyridinium chloride liquid

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

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Drug Label Information

Updated April 6, 2022

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  • ACTIVE INGREDIENT

    Cetylpyridinium chloride

  • INACTIVE INGREDIENT

    Concentrated Glycerin
    D-Sorbitol Solution
    Propolis Extract
    Chitosan
    Grapefruit Seed Extract
    Green Tea Extract
    Eucalyptus Extract
    Matricaria Extract
    Steviol Glycoside
    Xylitol
    Peppermint Flavor
    Gardenia Blue
    Sodium Bicarbonate
    Water

  • PURPOSE

    Clean mouth, remove plaque, clean mouth, remove odors

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Three times a day, put 5 drops of the concentrated solution into a sealed cup, addwater to the marked line, brush your teeth (gargle) with dilute solution for about 30seconds, and spit it out

  • WARNINGS

    1.Do not store it above 30°C2. Avoid exposure to heat, sparks and flames3. Be careful as it can irritate your eyes4.Wash with water when contacting eyes5. Store out of reach of infants and children

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DENTI WHOO BUBBLE CONCENTRATED GARGLE 
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86157-0004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE2.296 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86157-0004-150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/06/2022
    Labeler - SUN LIFE SCIENCE CO LTD (695149648)
    Registrant - SUN LIFE SCIENCE CO LTD (695149648)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUN LIFE SCIENCE CO LTD695149648manufacture(86157-0004)
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