NAFRINSE UNIT DOSE FLUORIDE

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.

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.

NAFRINSE UNIT DOSE FLUORIDE sodium fluoride solution

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Fluoride Ion 20 mg in 10 mL

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM Potassium Sorbate ANHYDROUS CITRIC ACID

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0273-8001-01 10 mL in 1 CUP None

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	Operations
Medical Products Laboratories, Inc		002290302	manufacture (0273-8001)

Revised: 12/2018 Young Dental Manufacturing Co 1, LLC.