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 53567-0552-1, 53567-0552-2, 53567-0552-3, 53567-0552-4, 53567-0552-8
Set ID 87489290-c2de-4fee-97b5-3639374e0eeb
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 Dihydrate, Sodium Bicarbonate, Calcium Carbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Flavor, Corn Starch, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Sodium Saccharin

  • Principal Display Panel

    supersmile®

    ORIGINAL MINT

    the whitening power of Calprox®

    professional

    whitening

    toothpaste

    Contains fluoride.

    4.2 oz / 119 g

    original_mint_4363

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0552
    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
    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)  
    MINT (UNII: FV98Z8GITP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (ORIGINAL MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0552-36 g in 1 TUBE; Type 0: Not a Combination Product05/01/2013
    2NDC:53567-0552-21 in 1 BOX05/01/2013
    2119 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:53567-0552-11 in 1 BOX05/01/2013
    340 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    4NDC:53567-0552-8227 g in 1 TUBE; Type 0: Not a Combination Product03/06/2018
    5NDC:53567-0552-470.8 g in 1 TUBE; Type 0: Not a Combination Product12/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2013
    Labeler - Robell Research, Inc. (155571656)
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