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
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated February 11, 2011
If you are a consumer or patient please visit this version.
- 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.Close
Topical neutral 1.1% sodium fluoride for use as a dental caries preventative in children and adults. This prescription product is not a dentifrice.Close
DO NOT SWALLOW. As with all medications, this product should be kept out of reach of children.Close
Accidental ingestion of a usual treatment dose (1-2mgF) is not harmful.Close
- STORAGE AND HANDLING
Store at temperature between 68º-77ºF (20º-25ºC).Close
Federal (U.S.A.) law prohibits dispensing without a prescription.Close
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.
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 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.
- SPL UNCLASSIFIED SECTION
MEDICAL PRODUCTS LABORATORIES, INC.
9990 Global Road • Phila., PA 19115-1083 800-523-0191 fax 215-677-7736 www.mplusa.comClose
- INGREDIENTS AND APPEARANCE
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10733-130 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 11 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45) 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)