DENTA 5000 PLUS BRAND OF 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM

DENTA 5000 PLUS BRAND OF 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM

Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients.

Sodium Fluoride 1.1% (w/w)

Water, Sorbitol, Hydrated Silica, Glycerin, Tetrapotassium Pyrophosphate, Flavor, PEG 12, Sodium Lauryl Sulfate, Carboxymethylcellulose Gum, Sodium Saccharin, Titanium Dioxide, FD&C Blue #1

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.

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 Denta 5000 Plus 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 in areas where drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

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

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 can not perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the dental cream, which could cause dental fluorosis. Read directions carefully before using.
Keep out of reach of infants and children.

Not for systemic treatment. DO NOT SWALLOW.

Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce emesis, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of Denta 5000 Plus contains 2.5 mg fluoride. A 1.8 oz. tube contains 255 mg fluoride.

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 Denta 5000 Plus 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, ages 6-16, expectorate after use and rinse mouth thoroughly.

Rx only

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.

Revision Date: 9/18

Rising                                                                        NDC 64980-305-50

Denta 5000 Plus

1.1% SODIUM FLUORIDE Prescription Dental Cream

5000 ppm Fluoride Plus Mild Cleaning System
Spearment

NET WT. 1.8 OZ (51 g)                                            Rx only

Denta-5000-Plus-51g-Carton