Fraiche 5000 Previ 1.1 %-3 % dental gel

Generic name:
Sodium fluoride/hydroxyapatite gel - dental

Brand name(s)
Fraiche 5000 Kids Plus , Fraiche 5000 Previ

This medication is used to prevent cavities and to reduce pain from sensitive teeth (dentinal hypersensitivity). Sodium fluoride and hydroxyapatite work by making the teeth stronger and more resistant to decay caused by acid and bacteria. Hydroxyapatite may also coat sensitive areas of the teeth.

Do not use this medication for children younger than 6 years unless directed by the doctor/dentist. Ask the doctor/dentist for more details about using this product safely for children. Caregivers/parents should watch the child to make sure the child does not swallow the medication while brushing.

Use this medication as directed by your doctor/dentist, usually twice daily (once in the morning and once in the evening).

Use this medication in place of your regular toothpaste unless otherwise directed by your doctor/dentist. Apply at least a 1-inch (2.5 centimeters) strip of the medication to a soft-bristled toothbrush, and brush your teeth for at least 1 minute. Spit out the medication after use and rinse your mouth thoroughly.

Do not swallow the medication. Make sure to brush all sensitive areas of the teeth.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Do not use this medication for longer than 4 weeks unless directed by your doctor/dentist. Sensitive/painful teeth may sometimes be a symptom of a serious problem that needs attention from a dentist.

Tell your doctor/dentist if your symptoms last or get worse.

Mouth/gum irritation may rarely occur. If this effect lasts or gets worse, tell your doctor/dentist or pharmacist promptly.

Tell your doctor/dentist right away if your teeth become stained or pitted. This is often a result of too much fluoride.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor/dentist or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor/dentist or pharmacist if you are allergic to sodium fluoride or hydroxyapatite; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor/dentist or pharmacist your medical history, especially of:

• mouth problems (such as sores, mucositis)

Tell your doctor if you are pregnant before using this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may be harmful if swallowed in large amounts. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: nausea/vomiting, increased saliva, stomach pain/cramping, muscle weakness, shaking.

Do not share this medication with others.

Using this medication does not replace good dental habits. Continue to floss your teeth regularly as directed by your dentist, and have regular dental checkups.

Sensitive teeth can be caused by damage to the hard outside surface of the tooth (enamel). Avoid acidic food/drinks (such as ginger ale, limes/lemons, citrus-based drinks, coffee), which can damage the tooth enamel. Consult your doctor/dentist for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.