EtheDent

EtheDent

INDICATIONS

A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 EtheDent™ brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

DOSAGE AND ADMINISTRATION

Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of EtheDent™ (sodium fluoride) to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime. 2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

HOW SUPPLIED

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

Last reviewed on RxList: 3/26/2008
This monograph has been modified to include the generic and brand name in many instances.

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