DentaGel

INDICATIONS AND USAGE: 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 DentaGel 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a 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: Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime. After use, adults expectorate gel. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly.

CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel, which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.

ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.