Sodium Fluoride Cream

Sodium Fluoride Cream is used for:

Preventing dental caries.

Sodium Fluoride Cream is a fluoride-containing toothpaste. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.

Do NOT use Sodium Fluoride Cream if:

• you are allergic to any ingredient in Sodium Fluoride Cream
• you have trouble swallowing

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sodium Fluoride Cream:

Some medical conditions may interact with Sodium Fluoride Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Sodium Fluoride Cream. However, no specific interactions with Sodium Fluoride Cream are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sodium Fluoride Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sodium Fluoride Cream:

Use Sodium Fluoride Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Brush your teeth with a small amount of Sodium Fluoride Cream. Swish it around your mouth for about 1 minute and then spit it out. Do not swallow it. Do not eat, drink, or rinse your mouth for 30 minutes after using Sodium Fluoride Cream.
• If you miss a dose of Sodium Fluoride Cream, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sodium Fluoride Cream.

Important safety information:

• Do not exceed the dose recommended by your doctor or dentist.
• Notify your dentist if your teeth become spotted or stained.
• Caution is advised when using Sodium Fluoride Cream in CHILDREN; they may be more sensitive to its effects
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Sodium Fluoride Cream, discuss with your doctor the benefits and risks of using Sodium Fluoride Cream during pregnancy. It is not known if Sodium Fluoride Cream is found in breast milk. If you are or will be breast-feeding while you are using Sodium Fluoride Cream, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Sodium Fluoride Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Sodium Fluoride Cream. Seek medical attention right away if any of these SEVERE side effects occur:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.

Store Sodium Fluoride Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Fluoride Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Sodium Fluoride Cream, please talk with your doctor, pharmacist, or other health care provider.
• Sodium Fluoride Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sodium Fluoride Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.