Label: CVS PHARMACY ENAMEL GUARD- sodium fluoride and potassium nitrite paste, dentifrice

  • NDC Code(s): 59779-815-42, 59779-815-49
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 01/13

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

  • Active ingredients

    Potassium Nitrate 5%......................................................................Antihypersensitivity

    Sodium Fluoride 0.15% w/v fluoride ion...........................................Anticavity

    Close
  • Uses

    aids in the prevention of dental caviites

    aids in reducing sensitivity

    Close
  • WARNINGS

    If pain/sensitivity 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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children. Children under 12 years of age: consult a dentist or doctor

    Close
  • Directions

    Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch. Brush teeth thorughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.

    Close
  • Other Information

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

    Close
  • Inactive ingredients

    water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidpropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

    Close
  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch.

    Close
  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

    Close
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  ENAMEL GUARD
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-815
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.15 g  in 100 g
    POTASSIUM NITRITE (NITRITE ION) POTASSIUM NITRITE 5.0 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL  
    TITANIUM DIOXIDE  
    GLYCERIN  
    SACCHARIN SODIUM  
    WATER  
    SODIUM HYDROXIDE  
    XANTHAN GUM  
    COCAMIDOPROPYL BETAINE  
    POLYETHYLENE GLYCOL 400  
    HYDRATED SILICA  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-815-49 1 in 1 CARTON
    1 NDC:59779-815-42 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 10/01/2012
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(59779-815), pack(59779-815)
    Close