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

  • Label RSS
  • NDC Code(s): 50227-1006-2
  • Packager: Patterson Dental Supply Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/12

If you are a consumer or patient please visit this version.

  • INDICATIONS

    Helps prevent dental caries and hypersensitivity.

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  • ACTIVE INGREDIENT

    Sodium Fluoride 1.1% (0.5% Fluoride Ion)

    OTHER INGREDIENTS

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

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  • 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.
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  • 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.

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  • PRECAUTIONS

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

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  • 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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    TAKE HOME FLUORIDE   COOL MINT
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50227-1006
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Sodium Fluoride 5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Anhydrous Citric Acid  
    Saccharin Sodium Dihydrate  
    Xylitol  
    Xanthan Gum  
    Glycerin  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor MINT (Cool Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50227-1006-2 1 in 1 BOX, UNIT-DOSE
    1 56 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/15/1997
    Labeler - Patterson Dental Supply Inc (171843584)
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