NAFRINSE UNIT DOSE FLUORIDE- sodium fluoride 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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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.

grape-sol

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)

Revised: 12/2018
Document Id: 2ba94fad-a133-4af0-8129-721741f6f949
Set id: 8eeaca73-0a28-4cbd-901d-cfc278ef1a9f
Version: 2
Effective Time: 20181214
 
Young Dental Manufacturing Co 1, LLC.