NAFRINSE UNIT DOSE MINT FLAVOR (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE BUBBLE GUM (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE VERRY BERRY (

NAFRINSE UNIT DOSE MINT FLAVOR (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE BUBBLE GUM (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE VERRY BERRY (
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NDC 0273-8002-01, 0273-8003-01, 0273-8004-01, 0273-8005-01
Set ID 757f1c48-f4ed-4021-a08b-f29bbeec74ff
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Young Dental Manufacturing Co 1, LLC.
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredients

    Sodium Fluoride

  • Inactives  

    Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

    Dye ( Only present in Mint and Very Berry flavors)

  • Purpose

    Prevention of dental caries.

  • Warning:

    a) Do not swallow b) Do not eat, drink or rinse with water for 30 minutes after use. c) Instruct children under 12 years of age in the use of the product and in good brushing and rinsing habits to minimize swallowing d) Not recommended for use in children younger than 6 years of age.

  • Dosage and Administration:

    DIRECTIONS FOR USE: {Best Results • Use Early Morning)

    1. Each pupil receives one cup and one napkin. 2. Have the pupils remove the lids from the cups. 3. Have the pupils empty the contents of the cup into their mouths and swish thoroughly for one minute. 4. HOLD CUP AGAINST THE MOUTH. Spit solution back into the cup. 5. Have the pupils wipe their mouths with the napkin; then stuff the napkin slowly into the cup to absorb the solution. 6. Discard the cup with the napkin into the provided trash bag. a) Do not swallow b) Do not eat, drink or rinse with water for 30 minutes after use. c) Instruct children under 12 years of age in the use of the product and in good brushing and rinsing habits to minimize swallowing d) Not recommended for use in children younger than 6 years of age. ADDITIONAL INSTRUCTIONS/IMPORTANT: In order to avoid spillage of the solution from the cup, the children must be instructed to do the following: 1) When spitting the fluoride solution from the mouth back into the cup, the children must hold the cup close to the mouth, and spit slowly into the cup. 2) The napkins must be stuffed into the cups very slowly in order to avoid spillage.

  • Keep out of reach of children

    Keep out of reach of children

  • Product Label

    Bubble 5Bubble 10

    MintVery Berry

  • INGREDIENTS AND APPEARANCE
    NAFRINSE UNIT DOSE MINT FLAVOR 
    sodium fluoride and hydrofluoric acid solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-8002-0110 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2017
    NAFRINSE UNIT DOSE BUBBLE GUM 
    sodium fluoride and hydrofluoric acid solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUM (bubble gum) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-8003-0110 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2017
    NAFRINSE UNIT DOSE BUBBLE GUM 
    sodium fluoride and hydrofluoric acid solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUM (bubble gum) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-8004-015 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2017
    NAFRINSE UNIT DOSE VERRY BERRY 
    sodium fluoride and hydrofluoric acid solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (very berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0273-8005-0110 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2017
    Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
    Registrant - Medical Products Laboratories, Inc (002290302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, Inc002290302manufacture(0273-8002, 0273-8003, 0273-8004, 0273-8005)

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