Label: FLUORIDE BITS- sodium monofluorophosphate 0.76% tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 19, 2023

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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)

  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE

    Helps protect against dental cavities

  • WARNINGS

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

    Keep out of reach of childrenunder 6 years of age.

  • DOSAGE & ADMINISTRATION

    Adult:

    Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or at least twice daily or as directed by a dentist or physician.

    Rinse after using.

    Do not swallow.

  • INACTIVE INGREDIENT

    Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.

  • OTHER SAFETY INFORMATION

    Store at room temperature and in a dry place

  • QUESTIONS

    BiteToothpaste.com

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    FLUORIDE BITS 
    sodium monofluorophosphate 0.76% tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82976-101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GUAR GUM (UNII: E89I1637KE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    Product Characteristics
    Colorwhite (WHITE TO OFF WHITE) Scorescore with uneven pieces
    ShapeROUNDSize6mm
    FlavorMINTImprint Code z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82976-101-00124 in 1 POUCH; Type 0: Not a Combination Product05/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/19/2023
    Labeler - The Kind Lab, Inc. (117339209)
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