EtheDent

1.8 oz. (51 g) net wt. tube NDC# 58177-835-37.

STORAGE: Store at Controlled Room Temperature, 20 - 25°C (68-77°F).

REFERENCES:

1. Accepted Dental Therapeutics, Ed. 40, ADA, Chicago. P.405-407, 1984.
2. Englander HR, Keyes et al: JADA 75:638-644, 1967.
3. Englander HR, et al: JADA 78:783-787. 1969.
4. Englander HR, et al: JADA 83:354-358, 1971.

Manufactured by: Sheffield Laboratories, New London, CT 06320 for ETHEX Corporation, St. Louis, MO 63043. Rev. 3/02. FDA rev date: n/a

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

In the U.S.

• APF Gel
• Aquafresh
• CaviRinse
• Control Rx
• Denta 5000 Plus
• Dentagel
• Dentall 1100 Plus
• EtheDent
• Fluorabon
• Fluor-A-Day
• Fluoridex Daily Defense
• Fluoridex Daily Defense Enhanced Whitening

In Canada

• Fluorosol
• Koala Pals Fluoride Tooth Gel - Berrylicious Flavor
• Pdf
• Pedi-Dent

Available Dosage Forms:

• Gel/Jelly
• Tablet, Chewable
• Paste
• Solution
• Tablet
• Liquid
• Cream
• Tablet, Enteric Coated
• Lozenge/Troche
• Suspension

Therapeutic Class: Cariostatic

Fluoride has been found to be helpful in reducing the number of cavities in the teeth. It is usually present naturally in drinking water. However, some areas of the country do not have a high enough level in the water to prevent cavities. To make up for this, extra fluoride may be added to the diet. Some children may require both dietary fluoride and topical fluoride treatments by the dentist. Use of a fluoride toothpaste or rinse may be helpful as well.

Taking extra oral fluoride does not replace good dental habits. These include eating a good diet, brushing and flossing the teeth often, and having regular dental checkups.

Fluoride may also be used for other conditions as determined by your doctor.

This medicine is available only with a prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. Doses of sodium fluoride that are too large or are taken for a long time may cause bone problems and teeth discoloration in children.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Older people are more likely to have joint pain, kidney problems, or stomach ulcers which may be made worse by taking large doses of sodium fluoride. You should check with your health care professional.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brown, white, or black discoloration of teeth or
• Joint pain or
• Kidney problems (severe) or
• Stomach ulcer—Sodium fluoride may make these conditions worse.

The level of fluoride present in the water is different in different parts of the U.S. If you move to another area, check with a health care professional in the new area as soon as possible to see if this medicine is still needed or if the dose needs to be changed. Also, check with your health care professional if you change infant feeding habits (e.g., breast-feeding to infant formula), drinking water (e.g., city water to nonfluoridated bottled water), or filtration (e.g., tap water to filtered tap water).

Do not take calcium supplements or aluminum hydroxide–containing products and sodium fluoride at the same time. It is best to space doses of these two products 2 hours apart, to get the full benefit from each medicine.

Inform your health care professional as soon as possible if you notice white, brown, or black spots on the teeth. These are signs of too much fluoride in children when it is given during periods of tooth development.