Label: MEDICHOICE FLUORIDE- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Sodium Monoflurophosphate - 0.76% (0.15% w/v fluoride ion)

    PURPOSE

    Anticavity

  • USE

    Aids in the prevention of dental cavities

  • WARNINGS

    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.

  • DIRECTIONS

    • Adults and children 2 years of age and olden Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age should use only a pea-sized amount in order to minimize swallowing. Supervise children and help them create good brushing and rinsing habits until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or a doctor.
  • INACTIVE INGREDIENTS

    CALCIUM CARBONATE,WATER,SORBITOL,PRECIPITATED SILICA,SODIUM LAURYL SULFATE, SODIUM CARBOXY METHYL CELLULOSE, SODIUM SILICATE TETRA SODIUM PYROPHOSPHATE, SODIUM SACCHARIN,METHYLPARABEN,TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400,PROPYLPARABEN

  • PRINCIPAL DISPLAY PANEL

    LL222

    LLL333

  • INGREDIENTS AND APPEARANCE
    MEDICHOICE FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0602
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39892-0602-117 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/01/2013
    Labeler - Owens & Minor Inc. (847412269)
    Registrant - Owens & Minor Inc. (847412269)
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