CVS PHARMACY RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]

  • Home
  • CVS PHARMACY RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]

CVS PHARMACY RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]
PDF | XML
NDC 69842-251-19
Set ID 99f86135-05b7-42b1-aef5-df4513259b8f
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART355
View All Sections
  • ACTIVE INGREDIENT

    Active ingredient

    Stannous Fluoride (0.454% w/w)

  • PURPOSE

    Purpose

    Anticavity/Antihypersensitivity

  • INDICATIONS & USAGE

    Uses

    • builds increasing protection against painful sensitivity of the teeth
    • aids in the prevention of dental cavities
  • WARNINGS

    Warnings

    Stop use and ask a dentist if

    • the problem persists or worsens​. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist
    • pain / sensitivity still persists after 4 weeks

    Keep out of reach of children. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

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

    • 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 physician. Make sure to brush all sensitive areas of the teeth
    • Do not swallow
    • Children under 12 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

    Inactive ingredients water, glycerin, hydrated silica, sodium tripolyphosphate, sodium saccharin, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium lauryl sulfate, flavor

  • PRINCIPAL DISPLAY PANEL

    Carton label

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY   RESTORE AND DEFEND
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-251
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.454 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-251-191 in 1 CARTON12/01/2015
    196.4 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 finalpart35610/01/2014
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(69842-251)
View All Sections

Related Drugs

Search DailyMed Drugs