1.1% Sodium Fluoride Prescription Dental Cream

Description

DESCRIPTION Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. ACTIVE INGREDIENTS: Sodium Fluoride USP 1.1% (w/w) INACTIVE INGREDIENTS: Purified Water, Sorbitol, Hydrated Silica, Glycerin, Tetrapotassium Pyrophosphate, Flavor, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Titanium Dioxide, FD&C Blue No. 1.

What Is 1.1% Sodium Fluoride Prescription Dental Cream Used For?

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 SF 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 whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Dosage and Administration

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 SF 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, age 6-16, expectorate after use and rinse mouth thoroughly.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.

Contraindications

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

Pregnancy and Breastfeeding

Pregnancy Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a taratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood.

Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Overdosage

OVERDOSAGE 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., 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, 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., 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of SF 5000 Plus contains 2.5 mg fluoride. A 1.8 oz. tube contains 255 mg fluoride.

How Supplied

HOW SUPPLIED 1.8 oz. (51 g) net wt. tube NDC# 60258-150-01. You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Cypress Pharmaceutical, Inc. at 1-800-793-2145 or FDA at 1-800-FDA-1088 (Toll Free).