Label: WALGREENS RESTORE AND DEFEND- stannous fluoride paste, dentifrice

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

Drug Label Information

Updated February 22, 2024

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  • ACTIVE INGREDIENT

    Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) .... Anticavity/Antihypersensitivity

  • INACTIVE INGREDIENT

    glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

  • INDICATIONS & USAGE

    Adults and children 12 years of age and older: apply at least a 1-inch strip of the produc tonto 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.

  • DOSAGE & ADMINISTRATION

    Aids in the prevention of dental cavities. Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

  • WARNINGS

    When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth pay indicate a serious problem that may need prompt care by a dentist. Pain/sensitivity still persists after 4 weeks of use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If more than used for bushing is accidentally swallowed, get medical help or contact a poison control center right away.

  • PURPOSE

    Products containing stannous fluoride may produce surface staining of the teeth. Adquate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. This product is specifically formulated to help prevent staining. Store below 30C (86F).

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    WALGREENS RESTORE AND DEFEND 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1599
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1599-091 in 1 BOX10/28/2022
    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 DrugM02110/28/2022
    Labeler - Walgreens (008965063)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(0363-1599) , pack(0363-1599)
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