Label: LORNAMEAD NATURAL WHITE- fluoride paste, dentifrice

  • NDC Code(s): 62721-0470-2, 62721-0470-3, 62721-0470-7, 62721-0470-9
  • Packager: Lornamead
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2024

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  • Active ingredient

    Potassium nitrate 5% ................................................... Antisensitivity

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

  • Uses

    • 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 do not use longer than 4 weeks unless recommended by a dentist or physician. Stop use and ask a dentist if the sensitivity problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

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

  • Directions

    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) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.

    Do not swallow

  • DOSAGE & ADMINISTRATION

    Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

  • Other Information

    Store in a cool dry place. Keep tube capped when not in use.

  • Inactive ingredients

    Water, Hydrated Silica, Sorbitol, Glycerin, Cocamidopropyl Betaine, PEG-12, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin, Red 40

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

  • INGREDIENTS AND APPEARANCE
    LORNAMEAD  NATURAL WHITE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0470
    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
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorMINT (Vanilla Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-0470-91 in 1 CARTON01/10/201305/23/2023
    1NDC:62721-0470-2128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:62721-0470-71 in 1 CARTON06/12/2023
    2NDC:62721-0470-396.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/01/2012
    Labeler - Lornamead (126440440)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(62721-0470) , pack(62721-0470)
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