Label: BEE SMART- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 Ingredients:

    Sodium Monofluorophosphate 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:
    Adult 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

    Bee Smart™
    QUALITY & VALUE

    TOOTHPASTE
    With Fluoride Anticavity Protection

    Fresh Mint Flavor

    NET WT 6.4 OZ (181g)

    Principal Display Panel – Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    Bee Smart™
    QUALITY & VALUE

    TOOTHPASTE
    With Fluoride Anticavity Protection

    Fresh Mint Flavor

    NET WT 6.4 OZ (181g)

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    BEE SMART 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6033
    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:68747-6033-11 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(68747-6033)
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