Label: LORNAMEAD NATURAL WHITE- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride 0.24% (w/w)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities

  • WARNINGS

    Warnings

    Keep out of reach of children under 6 years of age. 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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day or as recommended by a dentist or doctor.

    • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Children under 2 years of age: consult a dentist or doctor.
  • INACTIVE INGREDIENT

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

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    Comments? Questions?

    1-877-777-2743

    customer service@lornamead.com

    Lornamead™

    Manufactured by:

    Lornamead, Inc.

    Tonawanda, NY 14150

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Natural White

    Stain Removing Extreme

    ANTICAVITY FLUORIDE TOOTHPASTE

    Removes tough stains including coffee, tea, wine & tobacco

    NET WT 3.0 OZ (85 g)

    Stain Removing Ext Carton

  • INGREDIENTS AND APPEARANCE
    LORNAMEAD  NATURAL WHITE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0472
    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
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-0472-91 in 1 CARTON12/01/2012
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2012
    Labeler - Lornamead (126440440)
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