Label: CVS PHARMACY BRILLIANT WHITE- sodium fluoride paste, dentifrice

  • NDC Code(s): 59779-193-32, 59779-193-39
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Active ingredients / Purpose

    Sodium fluoride 0.243% ............Anticavity

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  • Uses

    • aids in the prevention of dental cavities
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  • WARNINGS

    Children under 2 years of age, consult a dentist or doctor

    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.

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  • 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.

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  • DOSAGE & ADMINISTRATION

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

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  • Other Information

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

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  • 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

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  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

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  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  BRILLIANT WHITE
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-193
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.243 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SACCHARIN SODIUM  
    SORBITOL  
    TITANIUM DIOXIDE  
    SODIUM HYDROXIDE  
    XANTHAN GUM  
    HYDRATED SILICA  
    SODIUM ACID PYROPHOSPHATE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    SODIUM LAURYL SULFATE  
    MICA  
    Product Characteristics
    Color blue (light blue with sparkles) Score     
    Shape Size
    Flavor MINT (mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-193-39 1 in 1 CARTON
    1 NDC:59779-193-32 164 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/20/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(59779-193), pack(59779-193)
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