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- sodium fluoride and hydrofluoric acid solution 
Young Dental Manufacturing Co 1, LLC.

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.

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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

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)

Revised: 12/2018
Document Id: 91d550c5-993f-4059-b369-c4401dfc80f2
Set id: 757f1c48-f4ed-4021-a08b-f29bbeec74ff
Version: 2
Effective Time: 20181214
 
Young Dental Manufacturing Co 1, LLC.