Label: FLUORISHIELD- sodium fluoride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 0273-8011-01 - Packager: Young Dental Manufacturing I, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 13, 2018
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- Inactives
- Warning:
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Directions
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.
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INGREDIENTS AND APPEARANCE
FLUORISHIELD
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8011 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 11 mg in 1 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0273-8011-01 114 g in 1 TUBE; Type 0: Not a Combination Product 09/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/21/2017 Labeler - Young Dental Manufacturing I, LLC (006309355) Registrant - Young Dental Manufacturing I, LLC (006309355) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 manufacture(0273-8011)
