Label: LUCKY SUPER SOFT SENSITIVE- sodium fluoride potassium nitrate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 7, 2017

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  • Active Ingredient

    Potassium nitrate - 5%

    Sodium fluoride - 0.24%

  • Purpose

    Antihypersensitivity

    Anticavity

  • Uses

    ■ builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact ■ aids in the prevention of dental cavities

  • Warnings

    When using this product ■ if pain/sensitivity still persists after 4 weeks of use please visit your dentist

  • Stop and ask a dentist

    ■ if problem the persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

  • Keep out of reach of children

    If you accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately

  • Directions

    adults and children 12 years and older brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist. Be sure to brush sensitive areas

    children under 12 years of age consult a dentist or doctor.

  • Inactive ingredients

    DC Yellow10, FDC Blue 1, flavor, glycerin, methylparaben, poly ethylene glycol 1500, propylparaben, silica, sodium benzoate, sodium carboxy methyl cellulose, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, treated water, tri sodium ortho phosphate

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPER SOFT  SENSITIVE
    sodium fluoride potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-550
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-550-43122 g in 1 TUBE; Type 0: Not a Combination Product02/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/27/2014
    Labeler - Delta Brands Inc (102672008)
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