Sodium Fluoride Toothpaste

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.

What Is Sodium Fluoride Toothpaste 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 TruGuard 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 TruGuard 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. Directions: Use As Directed This prescription dentifrice is recommended for adults and pediatric patients 6 years and older.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS: Allergic reaction and other idiosyncrasies have been rarely reported.

Contraindications

CONTRA INDICATIONS: 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 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 teratogen. 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 of 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 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 product 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 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 of 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 of 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.

How Supplied

HOW SUPPLIED : 4 oz. (112 gm) net wt. tube