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 53567-0748-2, 53567-0748-3
Set ID 5f4bd0ff-4ea2-3756-e053-2991aa0af689
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. For children under two years of age, consult a dentist or a doctor before use.

  • Inactive ingredients:

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

  • Principal Display Panel

    Supersmile®

    ROSEWATER MINT

    professional

    whitening

    toothpaste

    powered by Calprox®

    with fluoride.

    Net wt. 4.2 oz / 119 g

    Rosewater_image.jpg

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0748
    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
    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 (Rosewater Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0748-21 in 1 BOX05/01/2017
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53567-0748-3227 g in 1 TUBE; Type 0: Not a Combination Product03/06/2018
    3NDC:53567-0748-140 g in 1 TUBE; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2017
    Labeler - Robell Research, Inc. (155571656)
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