Label: SUPERSMILE- sodium monofluorophosphate paste, dentifrice 

  • Label RSS
  • NDC Code(s): 53567-0717-2, 53567-0717-5
  • Packager: Robell Research, Inc.
  • 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 11/12

If you are a consumer or patient please visit this version.

  • Active Ingredient:

    Sodium Monoflurophosphate

    (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, keep out of reach of children under 6 years old.

    If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

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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. 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 Phoshate 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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  • SPL UNCLASSIFIED SECTION

    Created by,

    ​DR.​IRWIN SMIGEL

    ​World Renowned

    Father of Aesthetic

    Dentistry

    For best results, place a pearl size drop of Whitening Toothpaste on a DRY toothbrush and brush in a circular motion for two minutes twice daily.

    Three month supply (when used as directed)

    Whitens - Calprox® safely lifts surface stains, maintains and enhances the vibrancy of professionally bleached teeth, restores bonding, caps, veneers and dentures to their original whiteness.

    Freshens - Lasting germicidal protection.

    Strengthens - Remineralizes tooth enamel.

    Protects - Fluoride prevents cavities.

    Safely - No harsh abrasives, no sensitivity.

    STORE IN A COOL PLACE. RECYCLABLE

    DETERMINE YOUR SMILE CARE NEEDS WITH A PERSONALIZED PROFILE AT WWW.SUPERSMILE.COM

    QUESTIONS: 1-800-784-SMILE or INFO@SUPERSMILE.COM

    © Robell Research, Inc., New York, NY 10022 Made in USA

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  • Principal Display Panel

    supersmile®

    CINNAMON

    professional

    whitening

    toothpaste

    Contains fluoride.

    4.2 oz / 119 g

    image description

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  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53567-0717
    Route of Administration DENTAL, ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
    SODIUM BICARBONATE  
    CALCIUM CARBONATE  
    TITANIUM DIOXIDE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    CALCIUM PEROXIDE  
    SODIUM PERBORATE  
    STARCH, CORN  
    MAGNESIUM CARBONATE  
    SODIUM LAURYL SULFOACETATE  
    METHYLPARABEN  
    SACCHARIN SODIUM  
    PROPYLPARABEN  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CINNAMON (Cinnamon) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53567-0717-2 1 in 1 BOX
    1 119 g in 1 TUBE
    2 NDC:53567-0717-5 14.2 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 01/01/2006
    Labeler - Robell Research, Inc. (155571656)
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