Label: SUPERSMILE PROFESSIONAL WHITENING- sodium monofluorophosphate paste, dentifrice

  • 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 10/12

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  • Active Ingredient:

    Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

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  • Purpose:

    Anticavity toothpaste

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  • Uses:

    Aids in the prevention of dental cavities.

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  • Warnings:

    As with all fluoride toothpastes,

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  • KEEP OUT OF REACH OF CHILDREN

    children under 6 years old.

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  • Directions:

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

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  • 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.

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  • 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

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  • Questions:

    1-800 -784 -SMILE

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  • Tube Label
  • INGREDIENTS AND APPEARANCE
    SUPERSMILE PROFESSIONAL  WHITENING
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53567-0101
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.76 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CALCIUM PEROXIDE  
    SODIUM PERBORATE  
    SODIUM BICARBONATE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    CALCIUM CARBONATE  
    MAGNESIUM CARBONATE  
    STARCH, CORN  
    SACCHARIN  
    METHYLPARABEN  
    PROPYLPARABEN  
    TITANIUM DIOXIDE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    SODIUM LAURYL SULFOACETATE  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53567-0101-6 227 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 06/28/2011
    Labeler - ROBELL RESEARCH, INC. (155571656)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(53567-0101), pack(53567-0101)
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