NAFRINSE UNIT DOSE FLUORIDE (SODIUM FLUORIDE) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC.]

NAFRINSE UNIT DOSE FLUORIDE (SODIUM FLUORIDE) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC.]
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NDC 0273-8001-01
Set ID 8eeaca73-0a28-4cbd-901d-cfc278ef1a9f
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Young Dental Manufacturing Co 1, LLC.
Generic Name
Product Class
Product Number
Application Number
  • Inactives  

    Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

    Dye 

  • Warning:

    For Topical use only.

    Federal (USA) law prohibits  dispensing without prescription

  • Directions

    Rinse for 1 minute and spit out. Do not swallow.

  • PRINCIPAL DISPLAY PANEL

    grape-sol

  • INGREDIENTS AND APPEARANCE
    NAFRINSE UNIT DOSE FLUORIDE 
    sodium fluoride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-8001-0110 mL in 1 CUP; Type 0: Not a Combination Product09/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/24/2017
    Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
    Registrant - Medical Products Laboratories, Inc (002290302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, Inc002290302manufacture(0273-8001)

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