SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]

  • Home
  • SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]

SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]
PDF | XML
NDC 53567-0760-1, 53567-0760-2
Set ID 8631f27c-9a8e-edb7-e053-2a91aa0a7978
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 as fluoride ion)

  • Purpose:

    Anticavity.

  • Uses:

    Aids in the prevention of 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.

  • 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 doctor before use.

  • Inactive Ingredients:

    Water, Sorbitol, Calprox®, Citric Acid, Dicalcium Phosphate, Sodium Bicarbonate, Titanium Dioxide, Calcium Carbonate, Cellulose Gum, Flavor, Sodium Perborate, Magnesium Carbonate, Corn Starch, Sodium Lauryl Suloacelate, Sodium Saccharin.

  • Principal Display

    supersmile®

    extra white

    lotus peach mintea

    professional

    extra

    whitening

    toothpaste

    Contains Fluoride

    7 oz / 198.5 g

    Peach 7.jpg

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0760
    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
    SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)  
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0760-1198.5 g in 1 TUBE; Type 0: Not a Combination Product04/15/2019
    2NDC:53567-0760-270.8 g in 1 TUBE; Type 0: Not a Combination Product04/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/15/2019
    Labeler - Robell Research, Inc. (155571656)
View All Sections

Related Drugs

Search DailyMed Drugs