Label: PLAQUE HD ANTICAVITY BERRY BUBBLE GUM FLAVOR PROFESSIONAL PLAQUE-IDENTIFYING- sodium fluoride paste, dentifrice

  • NDC Code(s): 57660-001-01, 57660-001-02
  • Packager: TJA Health LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • Drug Facts


  • Active ingredient

    Sodium Fluoride 0.24% (0.14% 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 or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 2 year of age: Consult a dentist or doctor
  • Other information

    • Store at room temperature
  • Inactive ingredients

    Water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophsphate, sodium bicarbonate, PVP, sodium benzoate, sodium lauryl sulfate, flavor, carbomer, cellulose gum, annatto extract, xylitol, sodium saccharin, disodium EDTA, blue 1.

  • Questions?

    call toll-free-1-(800) 737-4860

  • Package Labeling (57660-001-01)

    Box LabelBox Label2

  • Representative Labeling (57660-001-02)

    Box

    Tube

  • INGREDIENTS AND APPEARANCE
    PLAQUE HD ANTICAVITY BERRY BUBBLE GUM FLAVOR  PROFESSIONAL PLAQUE-IDENTIFYING
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57660-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY, BUBBLE GUM (Berry Bubble Gum Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57660-001-011 in 1 PACKAGE03/19/2014
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:57660-001-021 in 1 PACKAGE03/19/2014
    2116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/19/2014
    Labeler - TJA Health LLC (078799634)
    Registrant - TJA Health LLC (078799634)
    Establishment
    NameAddressID/FEIBusiness Operations
    TJA Health LLC078799634manufacture(57660-001)
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