SUPERSMILE PROFESSIONAL WHITENING (FLUORIDE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]

  • Home
  • SUPERSMILE PROFESSIONAL WHITENING (FLUORIDE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]

SUPERSMILE PROFESSIONAL WHITENING (FLUORIDE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]
PDF | XML
NDC 53567-0101-6
Set ID 43e5e8f9-1bb1-4154-b6a3-36af8c870c4d
Category HUMAN OTC DRUG LABEL
Packager ROBELL RESEARCH, INC.
Generic Name
Product Class
Product Number
Application Number PART355
View All Sections
  • 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

    children under 6 years old.

  • Directions:

    For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist.

  • Directions:

    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 Phosphate Dihydrate, Sodium Bicarbonate, Calcium Carbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Flavor, Corn Starch, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Methyl Paraben, Sodium Saccharin, Propyl Paraben

  • Questions:

    1-800 -784 -SMILE

  • Tube Label

    Tube Label

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE PROFESSIONAL  WHITENING
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    SODIUM PERBORATE (UNII: Y52BK1W96C)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SACCHARIN (UNII: FST467XS7D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0101-6227 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/28/2011
    Labeler - ROBELL RESEARCH, INC. (155571656)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440manufacture(53567-0101) , pack(53567-0101)
View All Sections

Related Drugs

Search DailyMed Drugs