Data from FDA - Curated by EPG Health - Last updated 05 December 2017

Indication(s)

1 INDICATIONS AND USAGE 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. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS 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. (4)
Adverse reactions
6 ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. Allergic reactions and other idiosyncrasies have been rarely reported. (6) 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

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION • 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)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 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. 8.3 Nursing Mothers An extremely small proportion of fluoride in drinking water is transferred to breast milk. The Institute of Medicine established a fluoride Upper Limit of 10 mg/day for nursing 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 women who are nursing. 8.4 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. 8.5 Geriatric Use No studies of Clinpro 5000 Anti-Cavity Toothpaste have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.
Pregnancy and lactation
8.3 Nursing Mothers An extremely small proportion of fluoride in drinking water is transferred to breast milk. The Institute of Medicine established a fluoride Upper Limit of 10 mg/day for nursing 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 women who are nursing.

More information

Category Value
Agency product number 8ZYQ1474W7
Orphan designation No
Product NDC 48878-3140,48878-3130,48878-3120
Date Last Revised 10-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 392038
Storage and handling Storage This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date. Manufactured for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA Revision date: 01/11/2012 Rx Only 3M, ESPE, and Clinpro are trademarks of 3M or 3M Deutschland GmbH. © 3M 2016. All rights reserved.
Marketing authorisation holder 3M ESPE Dental Products