Label: SUPERSMILE PROFESSIONAL WHITENING- fluoride 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 3, 2012

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  • Active Ingredient:

    Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

  • Purpose:

    Anticavity toothpaste

  • Uses:

    Aids in the prevention of dental cavities.

  • Warnings:

    As with all fluoride toothpastes,

  • KEEP OUT OF REACH OF CHILDREN

    children under 6 years old.

  • Directions:

    For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist.

  • Directions:

    Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.

  • Inactive Ingredients:

    Water, Sorbitol, Dicalcium Phosphate Dihydrate, Sodium Bicarbonate, Calcium Carbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Flavor, Corn Starch, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Methyl Paraben, Sodium Saccharin, Propyl Paraben

  • Questions:

    1-800 -784 -SMILE

  • Tube Label

    Tube Label

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE PROFESSIONAL  WHITENING
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    SODIUM PERBORATE (UNII: Y52BK1W96C)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SACCHARIN (UNII: FST467XS7D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0101-6227 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/28/2011
    Labeler - ROBELL RESEARCH, INC. (155571656)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440manufacture(53567-0101) , pack(53567-0101)
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