CVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]

CVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]
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NDC 59779-815-42, 59779-815-49
Set ID 18295a1c-c2a6-489b-be34-9252b9e1e2b8
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART355
  • Active ingredients

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

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

  • Uses

    aids in the prevention of dental caviites

    aids in reducing sensitivity

  • 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

  • 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.

  • Other Information

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

  • Inactive ingredients

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

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Carton R5

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  ENAMEL GUARD
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-815
    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
    POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608) POTASSIUM NITRITE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-815-491 in 1 CARTON01/07/2013
    1NDC:59779-815-42113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/01/2012
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(59779-815) , pack(59779-815)

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