Label: PRONAMEL REPAIR WHITENING- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2025

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  • ACTIVE INGREDIENT

    Potassium nitrate 5% .................................................. Antihypersensitivity

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

  • WARNINGS

    When using this product, if irritation occurs discontinue use.

    Stop use and ask a dentist if the problem persists or worsens.

    Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity stil persists after 4 weeks of use.

  • PURPOSE

    Anthihypersensitivity

    Anticavity

  • INDICATIONS & USAGE

    builds increasing protection against painful sensitivty of the teeth to cold, acids, sweets, or contact. Aids in the prevention of dental cavities.

  • KEEP OUT OF REACH OF CHILDREN

    If more than used for brushing is accidentaly 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 ontp 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

    2821076R1 Rite Aid Enamel Guard

  • INGREDIENTS AND APPEARANCE
    PRONAMEL REPAIR WHITENING 
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6310
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    Colorwhite (White) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6310-11 in 1 CARTON12/01/2024
    196 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/01/2024
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead Products (119559733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Products119559733manufacture(11822-6310) , pack(11822-6310)
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