Nafrinse
Name: Nafrinse
You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).
Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.
Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.
Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.
How should I take Nafrinse (fluoride)?
Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Take this medicine with a full glass of water.
Do not take fluoride with milk or other dairy products. Calcium can make it harder for your body to absorb fluoride.
Suck on the fluoride lozenge until it dissolves completely in your mouth. Do not chew the lozenge or swallow it whole.
The chewable forms of fluoride can be chewed, swallowed, dissolved in the mouth, added to drinking water or fruit juice, or added to water for use in infant formula or other food.
The fluoride drops can be taken by mouth undiluted, or mixed with fluid or food.
If you mix fluoride with food or water, drink or eat this mixture right away. Do not save it for later use.
It is important to take fluoride regularly to get the most benefit.
Store fluoride at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
What should I avoid while taking Nafrinse (fluoride)?
Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.
Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.
Inactives
Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring
Dye ( Only present in Mint and Very Berry flavors)
Product Label
Nafrinse UNIT DOSE MINT FLAVOR
sodium fluoride and hydrofluoric acid solution |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | 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 | | 1 | NDC:0273-8002-01 | 10 mL in 1 CUP | |
|
| 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 LABEL | 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 | | 1 | NDC:0273-8003-01 | 10 mL in 1 CUP | |
|
| 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 LABEL | 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 | | 1 | NDC:0273-8004-01 | 5 mL in 1 CUP | |
|
| 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 LABEL | 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 | | 1 | NDC:0273-8005-01 | 10 mL in 1 CUP | |
|
| 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) |
Revised: 08/2017 Young Dental Manufacturing Co 1, LLC.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Very upset stomach or throwing up.
For the Consumer
Applies to fluoride topical: dental cream, dental gel, dental paste, mouth/throat concentrate, mouth/throat liquid, mouth/throat paste, mouth/throat solution
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
