Label: NAFRINSE UNIT DOSE FLUORIDE- sodium fluoride solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 0273-8001-01 - Packager: Young Dental Manufacturing Co 1, LLC.
- 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.
Drug Label Information
Updated December 14, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Inactives
- Warning:
- Directions
- PRINCIPAL DISPLAY PANEL
-
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)
