Label: PRONAMEL REPAIR WHITENING paste, dentifrice

  • NDC Code(s): 56062-514-44
  • Packager: Publix Super Market Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2025

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  • ACTIVE INGREDIENT

    potassium nitrate 5%

    Sodium fluoride 0.25% (0.15% w/v fluoride ion)

  • PURPOSE

    Antihypersensitivity

    Anticavity

  • INDICATIONS & USAGE

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

  • WARNINGS

    When using this product, of iffitation occurs discontine use.

    Stop use and ask a dentist if the problem persists or worsen. Sensitive teeth may indicate a serious problem that many need prompt care by a dentist.* pain/sensitivty still persists after 4 weeks of use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If more than used for brushing is accidently swallowed, get medical help or contact a Posion Control Center right away.

  • DOSAGE & ADMINISTRATION

    adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.*children under 12 years of age: Consult a dentist or doctor.

  • INACTIVE INGREDIENT

    water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    Publix Enamel Guard Intensive

  • INGREDIENTS AND APPEARANCE
    PRONAMEL REPAIR WHITENING 
    pronamel repair whitening paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-514
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-514-441 in 1 CARTON09/01/2024
    196.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02209/01/2024
    Labeler - Publix Super Market Inc (006922009)
    Registrant - Lornamead Products (119559733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Products119559733pack(56062-514) , manufacture(56062-514)
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