Label: FLUORISHIELD- sodium fluoride gel 

  • NDC Code(s): 10733-130-04
  • Packager: Medical Products Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 02/11

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  • SPL UNCLASSIFIED SECTION

    Your dentist has selected for you FluoriShield, a 1.1% Sodium Fluoride product that was specially developed to prevent tooth decay which can occur from xerostomia (dry mouth). Dry mouth can result from radiation therapy, systemic diseases, medications which affect the salivary glands and mouth breathing. Clinical trials have shown that application of topical fluoride gel in the presence of good oral hygiene can prevent or significantly reduce tooth decay which is related to dry mouth.  FluoriShield topical fluoride gel can be applied with a custom carrier or tray, directly brushed on, or used with an over denture. Your dentist will prescribe the method that is best suited for your individual needs. The gel is easily dispensed when the bottle is inverted for storing.

    STORE INVERTED FOR EASY REMOVAL OF CONTENTS.

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  • Description:

    Topical neutral 1.1% sodium fluoride for use as a dental caries preventative in children and adults. This prescription product is not a dentifrice.

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  • Warnings:

    DO NOT SWALLOW. As with all medications, this product should be kept out of reach of children.

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  • Overdose:

    Accidental ingestion of a usual treatment dose (1-2mgF) is not harmful.

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  • STORAGE AND HANDLING

    Store at temperature between 68º-77ºF (20º-25ºC).

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  • CAUTION:

    Federal (U.S.A.) law prohibits dispensing without a prescription.

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  • INSTRUCTIONS

    Custom Carriers or Trays

    Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of FluoriShield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel.  Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

    Tray

    Brush On

    Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Apply a thin ribbon of gel to the toothbrush and spread evenly with the applicator tip of the fluoride bottle. Brush all tooth surfaces and allow fluoride to remain in place for one (1) minute or longer (as directed by your doctor). Clean carriers with cold water. Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

    Brush

    Overdentures

    Brush all tooth surfaces.  Clean your dentures. Adults and children 6 years of age or older: Apply one (1) or two (2)drops of FluoriShield to each tooth area in your denture and place the dentures in your mouth. Leave in place for one (1) minute or longer (as directed by your doctor).Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

    Denture
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  • SPL UNCLASSIFIED SECTION

    MEDICAL PRODUCTS LABORATORIES, INC.

    9990 Global Road • Phila., PA 19115-1083 800-523-0191 fax 215-677-7736 www.mplusa.com

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  • INGREDIENTS AND APPEARANCE
    FLUORISHIELD 
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10733-130
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 11 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SACCHARIN SODIUM  
    HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10733-130-04 66 in 1 CARTON
    1 114 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 11/29/2009
    Labeler - Medical Products Laboratories, Inc. (002290302)
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