Label: TOOTHPASTETABLETS- toothpaste tablets tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 9, 2023

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  • Active ingredient

    Sodium Monofluorophosphate 0.877% (1100ppm w/v fluoride ion)

  • Purpose

    Anticavity Toothpaste

  • Use

    aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children. Not to be used by children under 12 years of age.
    If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

  • DO NOT USE

    Not to be used by children under 12 years of age.

  • WHEN USING

    If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Adults: Wet your toothbrush and crush the tab between your teeth.
    Brush like normal. Rinse after using.
    Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow

  • Other Information

    Store at room temperature and dry place.

  • Inactive ingredients

    Sorbitol, Calcium Carbonate, Probiotics, Xylitol, Magnesium Stearate, Stevia Rebaudiana Extract,
    Tea (Camellia Sinensis) Polyphenols, Peppermint (Mentha Piperita) Oil, Bitter Orange (Citrus Aurantium) Flower Oil,
    Peppermint (Mentha Piperita) Leaf Oil, Cocamidopropyl Betaine.

  • Questions?

    Call (619) 940-6502

  • PRINCIPAL DISPLAY PANEL

    83525-001-01

    83525-001-01

    83525-001-11

    83525-001-11

  • INGREDIENTS AND APPEARANCE
    TOOTHPASTETABLETS 
    toothpaste tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83525-001
    Route of AdministrationPERIODONTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.877 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    COCO/OLEAMIDOPROPYL BETAINE (UNII: 5M84PX7JN2)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HEDEOMA PULEGIOIDES LEAF OIL (UNII: 3Z236RKQ9N)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    MENTHA SPICATA OIL (UNII: C3M81465G5)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code no
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83525-001-016 in 1 BOX06/09/2023
    1NDC:83525-001-1160 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/09/2023
    Labeler - HONG KONG DAILYGREEN TRADE CO., LIMITED (655740805)
    Establishment
    NameAddressID/FEIBusiness Operations
    HONG KONG DAILYGREEN TRADE CO., LIMITED655740805manufacture(83525-001) , label(83525-001)
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