Label: IODENT FLUORIDE MINT- 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 August 25, 2008

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium Monofluorophospate 0.76%

    (Total Fluoride Content – 1000 ppm Approx.)

  • Purpose

    Anticavity

  • Uses

    Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities

  • Warnings

    Keep out of reach of children under 6 years of age.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children
    2 years and older
    Brush teeth thoroughly after meals or at least twice a day or use as
    directed by a dentist or physician.
    Children under 6 yrs To minimize swallowing use a pea-sized amount and supervise brushing
    until good habits are established.
    Children under 2 yrs Ask a dentist or physician.
  • Ingredients

    Calcium Carbonate, Water, Sorbitol, Precipitated Silica, Sodium Lauryl sulphate, Flavor, Sodium Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methyl Paraben, Titanium Dioxide, Poly Ethylene Glycol 400, Propyl Paraben.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    IODENT® CAVITY FIGHTING TOOTHPASTE
    FLUORIDE Mint Flavor
    CAVITY PROTECTION & EXTRA BREATH FRESHENING
    NET WT 6.4 OZ (181g)

    Principal Display Panel – Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    IODENT® CAVITY FIGHTING TOOTHPASTE
    FLUORIDE Mint Flavor
    CAVITY PROTECTION & EXTRA BREATH FRESHENING
    NET WT 6.4 OZ (181g)

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    IODENT FLUORIDE MINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6032
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68747-6032-11 in 1 CARTON
    1181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/28/2012
    Labeler - Dabur India Limited (650319218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dabur India Limited650319218MANUFACTURE
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