Label: INTENSIVE ENAMEL REPAIR WHITENING TP paste, dentifrice

  • NDC Code(s): 36800-362-00, 36800-362-10
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 30, 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, 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 still persists after 4 weeks of use.

    Keep out of reach of children. If more than used for brushing is acidentally swallowed, get medical help or contact a Poison 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

    2821090R1

  • INGREDIENTS AND APPEARANCE
    INTENSIVE ENAMEL REPAIR WHITENING TP 
    intensive enamel repair whitening tp paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-362
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-8 (UNII: B697894SGQ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-362-001 in 1 CARTON06/17/202509/30/2025
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:36800-362-101 in 1 CARTON09/30/2025
    296.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/17/2025
    Labeler - Topco Associates LLC (006935977)
    Registrant - Lornamead Products (119559733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead119559733manufacture(36800-362) , pack(36800-362)
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