Label: LUCKY SUPER SOFT WHITENING ANTI CAVITY- sodium monofluorophosphate paste, dentifrice

  • 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 December 28, 2018

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  • Active Ingredient

    Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

  • Purpose

    Anticavity

  • Use

    regular brushing with fluoride tothpaste helps protect against cavities

  • Keep out of the reach of children

    under 6 years of age

  • Warnings

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

  • Directions

    adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

  • Inactive ingredients

    calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, FDC Blue 1, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, sodium lauryl sulfate, sodium saccharin, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPER SOFT  WHITENING ANTI CAVITY
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-553
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-553-012 in 1 BOX03/31/2017
    1NDC:20276-553-04113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/31/2017
    Labeler - Delta Brands Inc (102672008)
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