Label: LORNAMEAD NATURAL WHITE- fluoride 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 December 29, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Potassium Nitrate 5% (w/w)

    Sodium Fluoride 0.24% (w/w)

  • PURPOSE

    Purpose

    Antihypersenstivity

    Anticavity

  • INDICATIONS & USAGE

    Use

    aids in the prevention of dental cavities

  • WARNINGS

    Warnings

    If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

    • 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.
  • DOSAGE & ADMINISTRATION

    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.
    • Children under 12 years of age: consult a dentist or doctor.
  • INACTIVE INGREDIENT

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

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Lornamead, Inc.

    Tonawanda, NY 14150

    Made in USA

    Comments? Questions?

    Email us at: customerservice@lornamead.com

    or call 1-877-777-2743

  • PRINCIPAL DISPLAY PANEL

    Natural White

    Extreme Sensitive

    WHITENING TOOTHPASTE

    TARTAR CONTROL

    REDUCES SENSITIVITY

    FIGHTS CAVITIES

    NET WT. 4.5 OZ / 128 g

    Extreme Sensitive Tartar Control Carton

  • INGREDIENTS AND APPEARANCE
    LORNAMEAD  NATURAL WHITE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0471
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    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, UNSPECIFIED FORM (UNII: K679OBS311)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorMINT (Vanilla Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-0471-91 in 1 CARTON12/01/2012
    1128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2012
    Labeler - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.078584069manufacture(62721-0471)
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