Label: GOBY PEPPERMINT- sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL

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 April 19, 2021

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  • Drug Facts

  • Active Ingredients

    sodium fluoride, .24%
    (0.15% w/v fluoride ion)

    Purpose

    Anticavity

  • Use

    Helps prevent cavities

  • Warning

    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 immediately.

  • Directions

    Apply a pea-sized amount. Brush teeth thoroughly. Consult with a dentist or physician if needed.

  • Inactive Ingredients

    water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, PEG-12, flavor, titanium dioxide, cellulose gum, sodium benzoate, sodium saccharin

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    GOBY PEPPERMINT 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81788-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81788-001-0099 g in 1 TUBE; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2021
    Labeler - BGLG, Inc. (074391154)
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