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 53567-0926-1, 53567-0926-2, 53567-0926-3, 53567-0926-4
Set ID 112c0e8e-6733-40dc-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. Under two years of age consult a dentist or a doctor before use.

  • Inactive Ingredients:

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

  • Principal Display Panel

    supersmile®

    With the whitening power of Calprox®

    ICY MINT

    professional

    whitening

    toothpaste

    Contains fluoride.

    4.2 oz / 119 g

    icy_mint

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0926
    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
    MINT (UNII: FV98Z8GITP)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (ICY MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0926-11 in 1 BOX01/01/2014
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53567-0926-314 g in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    3NDC:53567-0926-440 g in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    4NDC:53567-0926-2227 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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