Label: PREMIERPRO FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice

  • 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 19, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Monofluorophosphate (0.76%)

  • PURPOSE

    Purpose: Anticavity

  • INDICATIONS & USAGE

    Uses: Aids in the prevention of dental cavities

  • WARNINGS

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under six years of age

  • ASK DOCTOR

    If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or physician.

  • INACTIVE INGREDIENT

    Calcium Carbonate, Carboxymethylcellulose Sodium, Flavour, Glycerin, Purified Water, Sodium Benzoate, Sodium Lauryl Sulfate, Hydrated Silica, Saccharin Sodium, Sorbitol, Tetrasodium Diphosphate.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PREMIERPRO FLUORIDE TOOTH 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69392-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69392-001-0114 g in 1 TUBE
    2NDC:69392-001-0224 g in 1 TUBE
    3NDC:69392-001-0342 g in 1 TUBE
    4NDC:69392-001-0478 g in 1 TUBE
    5NDC:69392-001-0585 g in 1 TUBE
    6NDC:69392-001-06130 g in 1 TUBE
    7NDC:69392-001-07198 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2015
    Labeler - SVS, LLC (DBA S2S Global) (831375089)
    Registrant - SVS, LLC (DBA S2S Global) (831375089)
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