Label: MEIJER DRY MOUTH- sodium fluoride paste, dentifrice

  • NDC Code(s): 41250-531-29
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium Fluoride (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use

    • aids in the prevention of dental cavities
  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children 12 years of age and under. 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 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.

    Children under 12 years of age: consult a dentist or physician. Once recommended, to minimize swallowing for children under 6,use a pea sized amount and supervise brushing until good habits are established.

  • STORAGE AND HANDLING

    Other information

    Store in a cool dry place. Keep tube capped when not in use.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide.

  • SPL UNCLASSIFIED SECTION

    DIST. BY

    MEIJER DISTRIBUTION INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • PRINCIPAL DISPLAY PANEL

    meijer™

    Dry Mouth Toothpaste

    Anticavity Toothpaste with Fluoride

    Fresh Mint

    Helps soothe dry mouth symptoms

    NET WT. 4.3 OZ (122 g)

    MeijerDrymouth 2821280R1

  • INGREDIENTS AND APPEARANCE
    MEIJER   DRY MOUTH
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-531
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-531-291 in 1 CARTON02/25/2019
    1122 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/25/2019
    Labeler - Meijer Distribution Inc (006959555)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(41250-531)
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