NAFRINSE UNIT DOSE FLUORIDE- sodium fluoride solution

NAFRINSE UNIT DOSE FLUORIDE by

Drug Labeling and Warnings

NAFRINSE UNIT DOSE FLUORIDE by is a Prescription medication manufactured, distributed, or labeled by Young Dental Manufacturing Co 1, LLC., Medical Products Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NAFRINSE UNIT DOSE FLUORIDE 
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0273-8001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	20 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (grape)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0273-8001-01	10 mL in 1 CUP; Type 0: Not a Combination Product	09/25/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/24/2017

Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)

Registrant - Medical Products Laboratories, Inc (002290302)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc		002290302	manufacture(0273-8001)