Label: TAKE HOME FLUORIDE COOL MINT- sodium fluoride gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Updated April 26, 2012

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  • INDICATIONS

    Helps prevent dental caries and hypersensitivity.

  • ACTIVE INGREDIENT

    Sodium Fluoride 1.1% (0.5% Fluoride Ion)

    OTHER INGREDIENTS

    Purified water, glycerin, Xylitol and other sweeteners. Contains FD&C Blue #1

  • DIRECTIONS

    Adults and children six years of age and older should brush with PATTERSON BRAND TAKE HOME FLUORIDE 1.1% NEUTRAL SODIUM FLUORIDE GEL, once at bedtime.

    1. Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered.
    2. Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes after use.
      Children 6 and older: expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste.
  • WARNINGS

    DO NOT SWALLOW. Supervision is required while children are using this product in order to avoid ingestion. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF INFANTS & CHILDREN.

  • PRECAUTIONS

    For Professional Use only. Federal (USA) law prohibits dispensing without a prescription. Store at controlled room temperature 68° -77° F (20° - 25°C).

  • SPL UNCLASSIFIED SECTION

    NDC# 5022710062

    Manufactured in the USA

    Questions? Call your dentist for more information.

    Distributed by
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    St. Paul, MN 55120

    Reorder# 088-6093 12/Case

  • PRINCIPAL DISPLAY PANEL - 56 gm Tube Label

    PATTERSON BRAND

    Take Home Fluoride
    1.1% Neutral Sodium Fluoride Gel

    Cool
    Mint

    Contains
    Xylitol
    Natural Sweetener

    Net Wt. 2 Oz (56gm)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    TAKE HOME FLUORIDE   COOL MINT
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50227-1006
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
    Xylitol (UNII: VCQ006KQ1E)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Glycerin (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Cool Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50227-1006-21 in 1 BOX, UNIT-DOSE
    156 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/15/1997
    Labeler - Patterson Dental Supply Inc (171843584)
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