Label: PREMIER VALUE CAVITY PROTECTION MINT- sodium monofluorophosphate paste

  • 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 January 7, 2011

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  • Active Ingredient

    Sodium MonoFluoroPhosphate 0.76% (0.015% w/v fluoride ion)           ...Anticavity Toothpaste

  • PURPOSE


  • KEEP OUT OF REACH OF CHILDREN


  • USE

    Helps protect against cavities.

  • WARNINGS

    As with all fluoride toothpastes, keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

  • Directions

    Adults and children        Brush teeth thoroughly, preferably
    2 years and older           after each meal, or at least twice a day, or as
                                        directed by your dentist. Do not swallow.

    Children under                To minimize swallowing, use a pea-sized
    6 years of age                amount and supervise brushing until
                                         good habits are established.

    Children under 2 years     Ask a dentist or physician.

  • Principal Display Panel

    image of container

  • Inactive Ingredients

    Sorbitol,Hydrated Silica,Water,Calcium Carbonate,Glycerine,Sodium Lauryl Sulphate,Cellulose Gum,Flavor,Sodium Benzoate,Sodium Saccharin, Sodium Phosphate,Titanium Dioxide,FDC BLUE NO. 1
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE CAVITY PROTECTION MINT 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-005-0121 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/08/2003
    Labeler - Premier Value (101668460)
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