Label: SMARTH EXTRA STRENGTH BAKING SODA- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 4, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

  • Purpose

    AntiCavity Toothpaste

  • Use

    aids in the prevention of dental cavities

  • Warning

    Keep out of the 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

    • Do not swallow
    • Supervise children as necessary until capable of using without supervision
    • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
    • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
    • Children under 6 years of age: Do not use unless directed by a doctor or dentist
  • Inactive Ingredients

    Sorbitol, Hydrated Silica, Demineralized Water, Sodium Lauryl Sulphate, Sodium Bicarbonate, Sod. CMC, Flavor, Sodium Benzoate, Sodium Saccharin

  • PRINCIPAL DISPLAY PANEL - 181g Tube Carton

    SMARTH™

    Extra Strength Fluoride Toothpaste

    BAKING SODA

    NET WT 6.4 Oz [181g]

    Principal Display Panel - 181g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SMARTH   EXTRA STRENGTH BAKING SODA
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60927-115
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O) Fluoride ion7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Water (UNII: 059QF0KO0R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60927-115-101 in 1 CARTON
    1181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/01/2013
    Labeler - Carib Sales, LLC (081234528)
    Registrant - Vikshara Trading & Investment Ltd (675920690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vikshara Trading & Investment Ltd675920690MANUFACTURE(60927-115)
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