Label: MEIJER RESTORE AND DEFEND SENSITIVE- stannous fluoride paste, dentifrice

  • NDC Code(s): 41250-530-19
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

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

  • PURPOSE

    Purpose

    Anticavity/Antihypersensitivity

  • INDICATIONS & USAGE

    Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities
  • WARNINGS

    Warnings

    If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

    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 of use

    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 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.
    • Minimize swallowing
    • Spit out after brushing
    • Children under 12 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    DIST. BY

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    meijer™

    WHITENING

    Restore & Defend Toothpaste

    For sensitive teeth and cavity protection

    Builds protective coating on sensitive areas of teeth

    NET WT 3.4 OZ (96.4 g)

    MeijerRestoreWhiten2821277R1

  • INGREDIENTS AND APPEARANCE
    MEIJER  RESTORE AND DEFEND SENSITIVE
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-530
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-530-191 in 1 CARTON02/25/2019
    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 DrugM02102/25/2019
    Labeler - Meijer Distribution Inc (006959555)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(41250-530)
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