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.

grape-sol
(click image for full-size original)

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.

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