SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]

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  • SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]

SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]
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NDC 53567-0752-1, 53567-0752-2
Set ID 7b06f2a6-5bad-1161-e053-2a91aa0a389a
Category HUMAN OTC DRUG LABEL
Packager Robell Research, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • Active Ingredient:

    Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

  • Purpose:

    Anticavity.

  • Uses:

    Aids in the prevention of dental cavities.

  • Warnings:

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • 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 ans rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. For children under two years of age consult a dentist or a doctor before use.

  • Inactive Ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    supersmile®

    with the whitening power of Calprox®

    BERRY CHILL

    professional

    whitening

    toothpaste

    contains fluoride

    8 oz / 226.7 g

    Berry_Chill_image.jpg

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0752
    Route of AdministrationDENTAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (Berry Chill) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0752-1226.7 g in 1 TUBE; Type 0: Not a Combination Product11/19/2018
    2NDC:53567-0752-270.8 g in 1 TUBE; Type 0: Not a Combination Product11/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/19/2018
    Labeler - Robell Research, Inc. (155571656)
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