Label: GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST- sodium fluoride gel

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

Drug Label Information

Updated October 30, 2025

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  • Active ingredient

    Sodium Fluoride 0.243%

    (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warnings

    Warnings

    When using this product

    • Do not swallow
    • Do not use in eye area

    Keep out of reach of children under 6 years

    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 older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or 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 years of age: Consult a dentist or doctor.
  • Inactive ingredients

    Water

    Glycerin

    Hydrated Silica

    Xylitol

    Sorbitol

    Cellulose Gum

    Flavor

    1,2-Hexanediol

    Sodium Phosphate

    Sodium Lauroyl Sarcosinate

    Tetrapotassium Pyrophosphate

    Sucralose

    Caprylyl Glycol

    Lauryl Glucoside

    Methyl Diisopropyl Propionamide

    Sodium Gluconate

    Zinc Lactate

    Red 40

    Blue 1

  • Label

    label

  • INGREDIENTS AND APPEARANCE
    GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83013-338
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BLUE 1 (UNII: H3R47K3TBD)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    TETRAPOTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    RED 40 (UNII: WZB9127XOA)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83013-338-10100 g in 1 TUBE; Type 0: Not a Combination Product10/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02110/30/2025
    Labeler - HISMILE PTY LTD (758083252)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrix International, LLC.117341868manufacture(83013-338)
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