Label: CVS EXTRA WHITENING- 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 November 5, 2012

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  • Active ingredients / Purpose

    Potassium nitrate 5%....................................................Antihypersensitivity

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

  • Uses

    aids in the prevention of dental cavities

  • WARNINGS

    If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    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

    Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

  • 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.

  • Other Information

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

  • Inactive ingredients

    cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

  • INGREDIENTS AND APPEARANCE
    CVS  EXTRA WHITENING
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-840
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) NITRATE ION5.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-840-091 in 1 CARTON
    1NDC:59779-840-02170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/20/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440manufacture(59779-840) , pack(59779-840)
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