Label: EXODEN SENSITIVE- tricalcium phosphate, silicon dioxide 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 11, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Tricalcium Phosphate 19%

    Silicon dioxide 2.5%

  • PURPOSE

    Anti plaque

  • INDICATIONS & USAGE

    Aids in cleanness of teeth and protection of gum health

  • 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, Xylitol, Stevioside, Glycyrrhiza Extract, Protease, Sodium Chloride, Camomille Extract(1), Scutellaria Root Extract, Sage Extract, Gentiana Extract, Fennel Extract , Sodium Cocoyl Glutamate, Tocopheryl Acetate, Mastic Oil, Eucalyptus Globulus Leaf Oil, L-Menthol, Peppermint Oil, Anethole, Carvone, Chamaecyparis Obtusa Oil, Potassium nitrate, Purified Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EXODEN SENSITIVE 
    tricalcium phosphate, silicon dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70602-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION19 g  in 100 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE2.5 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)  
    LICORICE (UNII: 61ZBX54883)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ANETHOLE (UNII: Q3JEK5DO4K)  
    CARVONE, (+/-)- (UNII: 75GK9XIA8I)  
    CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70602-006-021 in 1 CARTON03/11/2021
    1NDC:70602-006-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/11/2021
    Labeler - LIFEON Corp. (688528872)
    Registrant - LIFEON Corp. (688528872)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Life Science Co.,ltd694914835manufacture(70602-006)