Label: CVS PHARMACY RESTORE AND DEFEND- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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

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 ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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 DrugM02110/01/2014
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(69842-251)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!