Sodium fluoride dental rinse

A dental caries preventative for weekly self-applied topical use.  Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in pediatric patients.  Neutral Sodium Fluoride 0.2% Dental Rinse provides a ready- to-use preparation for convenient administration and favorable compliance.  May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.  (See WARNINGS for exception.)

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

Teratogenic Effects: 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 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 litter size or fetal weight and did not increase frequency of skeletal or visceral malformations.  There are no adequate and well-controlled studies in pregnant women.  However, 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.

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.

In patients with mucositis, gingival tissues may be hypersensitive to flavor or alcohol present in formulation.  Allergic reactions and other idiosyncrasies are rarely reported.

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)has 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) has been ingested, induce vomiting 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 (10 mL or two teaspoonfuls) of Neutral Sodium Fluoride 0.2% Dental Rinse contains approximately 9 mg of fluoride one 16 fl oz bottle contains approximately 429 mg fluoride.

Plastic bottle with child-resistant closure containing 16 fl oz (473 mL) (NDC 60258-158-16).

Store at Controlled Room Temperature, 20-25oC (68-77oF).