Label: SMARTH EXTRA STRENGTH WHITENING- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 8, 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

    Calcium Carbonate, Sorbitol, Demineralized Water, Tetra Sodium Ortho Phosphate, Tetra Sodium Pyro Phosphate, Sodium Lauryl Sulphate, Hydrated Silica, Sod. CMC, Flavor, Sodium Silicate, Sodium Benzoate, Sodium Saccharin

  • PRINCIPAL DISPLAY PANEL - 181g Tube Carton

    SMARTH™

    Extra Strength Whitening Fluoride Toothpaste

    Extra
    WHITENING

    NET WT 6.4 Oz [181g]

    Principal Display Panel - 181g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SMARTH   EXTRA STRENGTH WHITENING
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60927-118
    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
    Calcium Carbonate (UNII: H0G9379FGK)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Sodium Pyrophosphate (UNII: O352864B8Z)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Sodium Silicate (UNII: IJF18F77L3)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60927-118-131 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(60927-118)
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