Label: GO SMILE MINT- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 15, 2023

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  • PURPOSE

    ANTICAVITY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

  • DIRECTIONS

    Adults and children 2 years of age or older – Brush teeth thoroughly for 2 minutes at least twice a day preferably after each meal or as directed by a dentist or doctor.
    Children under 6 years of age – Instruct 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, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, sodium ascorbyl phosphate, tocopherol, retinyl palmitate, aloe barbadensis leaf juice, flavor, sodium lauryl sulfate, sodium methyl cocoyl taurate, sodium saccharin, cellulose gum, titanium dioxide

  • USES

    Aids in the prevention of dental cavities

  • ACTIVE INGREDIENTS

    Sodium Fluoride 0.24% (w/w)

  • WARNINGS

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

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • PRINCIPAL DISPLAY PANEL

    Toothpaste_Box_Final_OL_Crop Dieline

  • INGREDIENTS AND APPEARANCE
    GO SMILE  MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44873-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    VALERIAN (UNII: JWF5YAW3QW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44873-008-00100 g in 1 TUBE; Type 0: Not a Combination Product05/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/04/2016
    Labeler - Go Smile, Inc. (139729631)