Label: IODENT FLUORIDE MINT- sodium monofluorophosphate paste, dentifrice 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/08

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Sodium Monofluorophospate 0.76%

    (Total Fluoride Content – 1000 ppm Approx.)

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  • Purpose

    Anticavity

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  • Uses

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

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  • 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.

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  • 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.
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  • 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.

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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    IODENT FLUORIDE MINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68747-6032
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE  
    WATER  
    SORBITOL  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    SODIUM PYROPHOSPHATE  
    SACCHARIN SODIUM  
    TITANIUM DIOXIDE  
    METHYLPARABEN  
    POLYETHYLENE GLYCOL 400  
    PROPYLPARABEN  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (MINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68747-6032-1 1 in 1 CARTON
    1 181 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 02/28/2012
    Labeler - Dabur India Limited (650319218)
    Establishment
    Name Address ID/FEI Business Operations
    Dabur India Limited 650319218 MANUFACTURE
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