The Nafrinse Solution brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.
Dye ( Only present in Mint and Very Berry flavors)
Purpose
Prevention of dental caries.
Warnings
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.
Nafrinse 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
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
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)
Fluoride Ion
2 mg in 1 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
MINT (mint)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0273-8002-01
10 mL in 1 CUP; Type 0: Not a Combination Product
08/28/2017
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
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)
Fluoride Ion
2 mg in 1 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
BUBBLE GUM (bubble gum)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0273-8003-01
10 mL in 1 CUP; Type 0: Not a Combination Product
08/28/2017
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
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)
Fluoride Ion
2 mg in 1 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
BUBBLE GUM (bubble gum)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0273-8004-01
5 mL in 1 CUP; Type 0: Not a Combination Product
08/28/2017
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
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)
Fluoride Ion
2 mg in 1 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
BERRY (very berry)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0273-8005-01
10 mL in 1 CUP; Type 0: Not a Combination Product
08/28/2017
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)