Label: NATURAL WHITE RADIANT WHITE- fluoride paste, dentifrice

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

Drug Label Information

Updated February 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride 0.243%

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities

  • WARNINGS

    Warnings

    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 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    • Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Children under 12 years of age: consult a dentist or a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethylene

  • QUESTIONS

    Questions or comments? CALL 1-877-777-2743

  • SPL UNCLASSIFIED SECTION

    Comments? Questions?

    1-877-777-2473

    customerservice@lornamead.com

    Lornamead™

    Manufactured by:

    Lornamead, Inc.

    Tonawanda, NY 14150

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Carton R3

  • INGREDIENTS AND APPEARANCE
    NATURAL WHITE  RADIANT WHITE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0473
    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
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MICA (UNII: V8A1AW0880)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (light blue with sparkles) Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-0473-91 in 1 CARTON01/01/2013
    176 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2013
    Labeler - Lornamead (126440440)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(62721-0473) , pack(62721-0473)
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