Label: NAFRINSE PACKETS GRAPE- sodium fluoride powder

  • 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  

    Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

    Dye 

  • Warning:

    This Packet contains sodium fluoride powder, contents poisonous if swallowed. keep away from children. Store in a dry place at controlled room temperature. For professional use only.

    DO NOT SWALLOW

    MISSUSE If child swallows dispensed amount of mouth rinse in a cup:

    1. Do not panic -this amount should not hurt the child

    2. In rare cases the child may feel slightly nauseous.

    The child may have a serving of milk or ice cream to relieve the nausea. EMERGENCY TREATMENT If a child swallows more than one dispensed amount in a cup or powder contents of the fluoride mouth rinse packet call the Poison Control Center at 800-222-1222

  • Directions

    Mix contents with stated amount of tap water until dissolved (read directions on jug label) Makes an 0.2 % solution of sodium fluoride mouthrinse aftert dilution. Swish 10 ml (2 teaspoons) around vigorously in the mouth for one minute and then spit out. To be used once a week.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NAFRINSE PACKETS GRAPE 
    sodium fluoride powder
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8015
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 g  in 1 g
    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:0273-8015-0250 in 1 PACKAGE09/21/2017
    12 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/21/2017
    Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
    Registrant - Young Dental Manufacturing Co 1, LLC. (006309355)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, Inc.002290302manufacture(0273-8015)
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