Label: EXODEN CAVITY- silicon dioxide, aluminum chlorohydroxy allantoinate, sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 10, 2021

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  • ACTIVE INGREDIENT

    Silicon dioxide 15%

    Alcloxa 0.16%

    Sodium Monofluorophosphate 0.76%

  • PURPOSE

    Anti plaque

    Periodontal disease prevention

    Anti-cavity

  • INDICATIONS & USAGE

    Aids in prevention of dental cavities

  • DOSAGE & ADMINISTRATION


    Supervise children as necessary until capable of using without supervision

    Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician

    Children under 12 years: Instruct in good brushing and rinsing habits (to minimize swallowing)

    Children under 6 years: Do not use unless directed by a dentist or a physician

  • WARNINGS

    Ask a dentist before use if you have
    • bleeding or redness lasting more than 2 weeks
    • pain, swelling, pus, loose teeth, or more spacing between teeth
    These may be signs of periodontitis, a serious form of gum disease

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • INACTIVE INGREDIENT

    Glycerin, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Hydroxyapatite, Dental-Type Silica, Hydrated Silicon Dioxide, Xylitol, Glucosyl Stevioside, Protease, Lemon Extract, Lime Extract, Sodium Chloride, Tricalcium Phosphate, Potassium nitrate, Sodium Cocoyl Glutamate, Propolis Extract, Green Tea Extract, Mastic Oil, Chamaecyparis Obtusa Oil, Peppermint Oil, Eucalyptus Globulus Leaf Oil, L-Menthol, Titanium Oxide, Purified Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EXODEN CAVITY 
    silicon dioxide, aluminum chlorohydroxy allantoinate, sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70602-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.16 g  in 100 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15 g  in 100 g
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLUCOSYL STEVIOL (UNII: TKD5UC898Q)  
    LEMON (UNII: 24RS0A988O)  
    LIME (CITRUS) (UNII: 8CZS546954)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70602-005-021 in 1 CARTON03/10/2021
    1NDC:70602-005-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/10/2021
    Labeler - LIFEON Corp. (688528872)
    Registrant - LIFEON Corp. (688528872)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Life Science Co.,ltd694914835manufacture(70602-005)