NAFRINSE UNIT DOSE MINT FLAVOR: Package Insert and Label Information

NAFRINSE UNIT DOSE MINT FLAVOR- sodium fluoride solution
NAFRINSE UNIT DOSE BUBBLE GUM- sodium fluoride solution
NAFRINSE UNIT DOSE VERRY BERRY- 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.

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 5
(click image for full-size original)
Bubble 10
(click image for full-size original)

Mint
(click image for full-size original)
Very Berry
(click image for full-size original)

NAFRINSE UNIT DOSE MINT FLAVOR
sodium fluoride and hydrofluoric acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8002
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
Potassium Sorbate
ANHYDROUS CITRIC ACID
Product Characteristics
Color Score
Shape Size
Flavor MINT (mint) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-8002-01 10 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2017
NAFRINSE UNIT DOSE BUBBLE GUM
sodium fluoride and hydrofluoric acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8003
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
Potassium Sorbate
ANHYDROUS CITRIC ACID
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM (bubble gum) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-8003-01 10 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2017
NAFRINSE UNIT DOSE BUBBLE GUM
sodium fluoride and hydrofluoric acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8004
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
Potassium Sorbate
ANHYDROUS CITRIC ACID
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM (bubble gum) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-8004-01 5 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2017
NAFRINSE UNIT DOSE VERRY BERRY
sodium fluoride and hydrofluoric acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8005
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
Potassium Sorbate
ANHYDROUS CITRIC ACID
Product Characteristics
Color Score
Shape Size
Flavor BERRY (very berry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-8005-01 10 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2017
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 (0273-8002), manufacture (0273-8003), manufacture (0273-8004), manufacture (0273-8005)

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

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