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Nafrinse Prescribing Information

Package insert / product label
Generic name: sodium fluoride and hydrofluoric acid
Dosage form: solution
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Jun 15, 2023.

Active Ingredients

Sodium Fluoride

Inactives

Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

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

Bubble 5Bubble 10

MintVery Berry

NAFRINSE UNIT DOSE MINT FLAVOR
sodium fluoride and hydrofluoric acid solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Product Characteristics
Color Score
ShapeSize
FlavorMINT (mint) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-8002-0110 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2017
NAFRINSE UNIT DOSE BUBBLE GUM
sodium fluoride and hydrofluoric acid solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Product Characteristics
Color Score
ShapeSize
FlavorBUBBLE GUM (bubble gum) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-8003-0110 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2017
NAFRINSE UNIT DOSE BUBBLE GUM
sodium fluoride and hydrofluoric acid solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8004
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Product Characteristics
Color Score
ShapeSize
FlavorBUBBLE GUM (bubble gum) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-8004-015 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2017
NAFRINSE UNIT DOSE VERRY BERRY
sodium fluoride and hydrofluoric acid solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8005
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Product Characteristics
Color Score
ShapeSize
FlavorBERRY (very berry) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-8005-0110 mL in 1 CUP; Type 0: Not a Combination Product08/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2017
Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
Registrant - Medical Products Laboratories, Inc (002290302)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc002290302manufacture(0273-8002, 0273-8003, 0273-8004, 0273-8005)