Clinpro 5000 Drug Information

Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.

• Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist.
• Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes.
• After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water.
• Follow these instructions or use as directed by a dental professional. Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist. ( 2 ) Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes. ( 2 ) After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water. ( 2 )

Allergic reactions and other idiosyncrasies have been rarely reported. Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact 3M ESPE Dental Products Division at 1-800-634-2249 or www.3MESPE.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Pregnancy Fluoride crosses the placenta in women and has been measured in cord blood, amniotic fluid, and serum of newborn children, but without a consistent correlation to maternal serum fluoride levels. 1,2 There are no data to indicate an increased susceptibility to fluorosis during pregnancy. Developmental studies were conducted by the National Toxicology Program, with sodium fluoride administered in the drinking water to pregnant rats and rabbits. No developmental toxicity was observed, even at doses that caused maternal toxicity.

The No Adverse Effect Levels were about 29 mg/kg-day and 27 mg/kg-day for rabbits and rats, respectively. 3 There is no conclusive evidence of fluoride developmental effects in humans. 1,2 The Institute of Medicine established a fluoride Upper Limit of 10 mg/day for pregnant women. 2 Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water and other sources) when prescribing the product for use in pregnant women or women who may become pregnant.

Pediatric Use The primary adverse effects of fluoride are fluorosis of dental enamel and of the skeleton; these effects occur at exposures below those associated with other adverse health effects. The population most at risk for dental fluorosis is children during the period of tooth formation, i.e. from birth to 8 years of age. For this population, the Institute of Medicine established Fluoride Upper Limits of intake based on the risk of dental fluorosis.

In populations with permanent dentition, skeletal fluorosis is the greatest risk from excessive fluoride. For this population the Institute of Medicine (IOM) established Fluoride Upper Limits based on the risk of skeletal fluorosis. 2 Population IOM Fluoride Upper Limit Infants 0-6 months old 0.7 mg/day Infants 7-12 months old 0.9 mg/day Children 1-3 years old 1.3 mg/day Children 4-8 years old 2.2 mg/day Children > 8 years old 10 mg/day Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water and other sources) when prescribing the product for use in children.

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

Ingestion of large amounts of fluoride may result in abdominal pain, stomach upset, nausea, vomiting, and diarrhea. These symptoms may occur at overdosages of 5 mg/kg of body weight. Fluoride doses of 16 mg/kg have been fatal.

Treatment Recommendations for Overdose of Clinpro 5000 Anti-Cavity Toothpaste 4 Ingested fluoride dose Amount for 10 kg (22 pound) child* Recommended action to take Less than 5 mg/kg This equals less than ½ ounce (or less than 3 teaspoons). Do not induce vomiting. Give 1-2 glasses of milk and observe for symptoms of stomach upset. If symptoms persist more than a few hours, seek medical attention or contact a poison control center. 5 mg/kg or more This equals about ½ ounce (about 1 tablespoon) or more.

Do not induce vomiting. Give 1-2 glasses of milk and seek medical attention or contact a poison control center. 15 mg/kg This equals 1 ounce or ¼ of the tube. Seek immediate medical attention.

Do not induce vomiting. Give 1-2 glasses of milk. *The amount to reach the fluoride dose will be proportionately larger with older children and adults. A thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste weighs approximately 0.3 g and contains approximately 1.5 mg of fluoride ion.

A 4 oz. tube contains 564 mg of fluoride ion.