Sodium Fluoride; Potassium Nitrate Dental Gel or Paste

What is this medication?

SODIUM FLUORIDE; POTASSIUM NITRATE (SOE dee um FLOOR ide; poe TASS i um nye trate) prevents tooth decay. It may also be used to reduce gum and tooth sensitivity. It works by making your teeth stronger. It also calms the nerves in your teeth, which reduces pain. Fluoride is a mineral that plays an important role in the health of your teeth and bones.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): FLUORIDEX, FluoriMax 5000, Fraiche 5000, PreviDent 5000 Booster Enamel Protect, PreviDent 5000 Sensitive, Sensodyne, Sensodyne Deep Clean + Whitening, Sensodyne Pronamel, Wentworth Sodium Fluoride

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Stained, mottled, or pitted teeth
• An unusual or allergic reaction to fluoride, potassium nitrate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is applied to the teeth. Follow these instructions unless your dentist tells you otherwise: Apply at least 1 inch of paste to a soft-bristled toothbrush. Brush thoroughly twice daily for at least 1 minute. After using, spit the paste out and rinse your mouth. Do not swallow the paste.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your dentist for regular checks on your teeth.

Do not swallow this toothpaste. It has prescription-strength fluoride in it. The toothpaste you buy at the store has a much lower amount of fluoride in it. Regular swallowing of this paste can cause your teeth to change color. Report any changes in tooth color, such as new or unusual staining or spotting of the teeth.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in tooth color

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Irritation inside the mouth or throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep the container tightly closed. Throw away any unused paste after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.