There are many brands and forms of fluoride topical available. Not all brands are listed on this leaflet.

Fluoride topical is used to help prevent cavities, tooth decay, and gum disease. Fluoride topical can also help strengthen tooth enamel, remove plaque bacteria from teeth and gums, and decrease painful tooth sensitivity.

Fluoride may also be used for purposes not listed in this medication guide.

Follow all directions on the label and package, or use exactly as prescribed by your dentist or doctor.

Read and carefully follow all Instructions for Use on the label of your fluoride topical product. Ask your dentist or call the product manufacturer if you do not understand these instructions.

Do not swallow fluoride topical. It is for use only on your teeth and gums.

Fluoride preventive treatment gel should not be used as a toothpaste for regular brushing.

Do not allow a young child to use fluoride topical without help from an adult.

Fluoride topical rinse or gel can stain your teeth. Regular brushing can help prevent this.

Do not eat or drink anything or rinse your mouth for 30 minutes after using fluoride topical.

Do not use fluoride topical rinse to treat tooth sensitivity for longer than 4 weeks unless your dentist or doctor tells you to.

Stop using fluoride topical and call your dentist or doctor if your tooth sensitivity does not improve, or if it gets worse.

Store at room temperature away from moisture and heat. Do not freeze. Avoid extreme heat.

Usual Adult Dose for Prevention of Dental Caries:

Apply a small amount of fluoride toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute.

After use, expectorate.

For best results, do not eat, drink, or rinse for 30 minutes.

Use twice daily as your normal dentifrice or as directed by your dental professional.

Usual Pediatric Dose for Prevention of Dental Caries:

Less than 6 years of age: Do not use unless recommended by a dentist or physician.

Age 6 to 17:
Apply a small amount of fluoride toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute.

Expectorate after use and rinse mouth thoroughly.

Use twice daily as your normal dentifrice or as directed by your dental professional.

You should not use fluoride topical if you are allergic to it.

If you are using a prescription toothpaste, tell your dentist or doctor if you have kidney disease.

Ask a doctor before using fluoride topical if you are pregnant or breastfeeding.

Do not use fluoride topical in a child without the advice of a doctor or dentist. Some forms of fluoride topical should not be used in children of certain ages.

Use the dose as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may result if you swallow large amounts of fluoride while using it.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, burning in the mouth, and sore tongue.

More serious overdose symptoms may include severe stomach cramps and coughing up blood.

Avoid swallowing fluoride topical. Spit it out after use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if your sensitivity does not improve, or if it gets worse.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.