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

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SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]
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NDC 53567-0738-1, 53567-0738-2, 53567-0738-3, 53567-0738-4
Set ID 5f4c1a62-fb88-8cdc-e053-2a91aa0a671a
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 toothpaste

  • Uses:

    Aids in the prevention of dental cavities.

  • 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.

  • 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.

  • Directions:

    For the 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.

  • Inactive ingredients:

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

  • Principal Display Panel

    supersmile®

    extra white

    triple mint

    professional extra

    whitening

    toothpaste

    Contains Fluoride

    7 oz / 198.5 g

    Extra_White_image.jpg

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0738
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Triple Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0738-1198.4 g in 1 TUBE; Type 0: Not a Combination Product11/04/2016
    2NDC:53567-0738-2198.4 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/13/2017
    3NDC:53567-0738-370.8 g in 1 TUBE; Type 0: Not a Combination Product05/23/2018
    4NDC:53567-0738-41 in 1 BOX08/07/2018
    46 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/04/2016
    Labeler - Robell Research, Inc. (155571656)
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