Label: SUPERSMILE- sodium monofluorophoshate paste, dentifrice

  • NDC Code(s): 53567-0772-1, 53567-0772-2, 53567-0772-3
  • Packager: Robell Research, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 12, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient:

    Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

  • Purpose:

    Anticavity

  • Uses:

    Aids in the prevention of dental cavities

  • Warnings:

  • 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:

    Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age about good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

  • Ingredients:

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

  • Principal Display Panel

    supersmile

    THE WORKS

    All you need for a

    whiter, healthier smile

    TROPICAL MINT

    Powered by CALPROX®

    to give you the whitest + cleanest teeth

    without abrasion or sensitivity.

    whitening toothpaste

    Contains Fluoride

    Net wt. 8 oz / 227 g

    Supersmile_Tropical_Mint.jpg

  • PRINCIPAL DISPLAY PANEL

    supersmile

    SASSY MINT

    THE WORKS

    whitening

    toothpaste +

    activator

    Powered by CALPROX®

    Contains Fluoride

    Net Wt. 7 oz / 198.5g

    sassy_mint.jpg

  • INGREDIENTS AND APPEARANCE
    SUPERSMILE 
    sodium monofluorophoshate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0772
    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
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    METHYL 2-OCTENOATE, (E)- (UNII: 9EN9V40J78)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    .ALPHA.-AMYLCINNAMYL ALCOHOL (UNII: DKB52S61GU)  
    ANISYL ALCOHOL (UNII: 7N6XGV3U49)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    SORBITOL (UNII: 506T60A25R)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    GERANIOL (UNII: L837108USY)  
    FARNESOL (UNII: EB41QIU6JL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    COUMARIN (UNII: A4VZ22K1WT)  
    ISOEUGENOL (UNII: 5M0MWY797U)  
    CITRAL (UNII: T7EU0O9VPP)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    EUGENOL (UNII: 3T8H1794QW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53567-0772-1227 g in 1 TUBE; Type 0: Not a Combination Product04/11/2022
    2NDC:53567-0772-240 g in 1 TUBE; Type 0: Not a Combination Product04/14/2023
    3NDC:53567-0772-3198.5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/11/2022
    Labeler - Robell Research, Inc. (155571656)