Label: RESTORE AND DEFEND WHITENING TP- stannous fluoride paste, dentifrice

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

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Stannous fluoride 0.454% (0.15% w/v fluoride ion)

  • INACTIVE INGREDIENT

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

  • PURPOSE

    Anticavity, Antihypersensitivity

  • INDICATIONS & USAGE

    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 using 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/sensitivty still persists after 4 weeks of use

    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If more than used for brushing is accidentally 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 emal 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.

  • PRINCIPAL DISPLAY PANEL

    2821083R1

  • INGREDIENTS AND APPEARANCE
    RESTORE AND DEFEND WHITENING TP 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-256
    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
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White to white with Sl yellow hue) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-256-011 in 1 CARTON12/18/2024
    196 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/18/2024
    Labeler - Kroger (006999528)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead, Inc080046418manufacture(30142-256) , pack(30142-256)
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