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 53567-0933-1, 53567-0933-2, 53567-0933-5
Set ID 112ceaa4-b779-60b3-e054-00144ff8d46c
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 Monoflurophosphate (0.14% w/v Fluoride Ion)

  • Purpose:

    Anticavity toothpaste.

  • 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 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 Phoshate, Calcium Carbonate, Sodium Bicarbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Corn Starch, Magnesium Carbonate, Flavor, Sodium Lauryl Sulfoacetate, Sodium Saccharin

  • Principal Display Panel

    supersmile®

    CINNAMON

    professional

    whitening

    toothpaste

    powered by Calprox®

    with fluoride

    Net wt. 1.4 oz / 40 g

    Supersmile_Cinnamon_image.jpg

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0933
    Route of AdministrationORAL, DENTAL
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCINNAMON (Cinnamon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0933-21 in 1 BOX01/01/2014
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53567-0933-540 g in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    3NDC:53567-0933-114.2 g in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2014
    Labeler - Robell Research, Inc. (155571656)
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