Label: NAFRINSE UNIT DOSE FLUORIDE- sodium fluoride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 0273-8001-01 - Packager: Young Dental Manufacturing Co 1, LLC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated December 14, 2018
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- Inactives
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INGREDIENTS AND APPEARANCE
NAFRINSE UNIT DOSE FLUORIDE
sodium fluoride solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 20 mg in 10 mL Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) Potassium Sorbate (UNII: 1VPU26JZZ4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color Score Shape Size Flavor GRAPE (grape) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0273-8001-01 10 mL in 1 CUP; Type 0: Not a Combination Product 09/25/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/24/2017 Labeler - Young Dental Manufacturing Co 1, LLC. (006309355) Registrant - Medical Products Laboratories, Inc (002290302) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc 002290302 manufacture(0273-8001)