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These highlights do not include all the information needed to use Clinpro 5000 Anti-Cavity Toothpaste safely and effectively. See full prescribing information for Clinpro 5000 Anti-Cavity Toothpaste.Initial U.S. Approval: None Clinpro 5000 1.1% Sod | Clinpro 5000

05:29 EDT 27th August 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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

White toothpaste containing 1.1% sodium fluoride

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

Allergic reactions and other idiosyncrasies have been rarely reported.

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. 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. There is no conclusive evidence of fluoride developmental effects in humans.

The Institute of Medicine established a fluoride Upper Limit of 10 mg/day for pregnant women.

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.

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. 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.

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.

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.

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

No studies of Clinpro 5000 Anti-Cavity Toothpaste have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.

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.

*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.
Treatment Recommendations for Overdose of Clinpro 5000 Anti-Cavity Toothpaste4
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 2 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 2 teaspoons) 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.

Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste is a self-applied fluoride dentifrice for the prevention of dental caries. Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin and tri-calcium phosphate.

Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste aids in the prevention of tooth decay. Fluoride delivered from Clinpro 5000 inhibits the demineralization of sound teeth and enhances the remineralization (i.e., repair) of demineralized teeth. During tooth brushing, fluoride is taken up by teeth and dental plaque. Fluoride is taken up with calcium and phosphate by demineralized teeth resulting in an improved tooth structure than contains more fluoride and less carbonate than naturally occurring tooth structure and is more resistant to acid challenge. Additionally, calcium fluoride is formed on the crystal structure of teeth. As the pH of the mouth drops, fluoride is released from calcium fluoride and aids in the remineralization of teeth. Fluoride taken up into plaque alters the activity of cariogenic bacteria. Fluoride inhibits the process by which cariogenic bacteria metabolize carbohydrates resulting in less acid and adhesive polysaccharide production by the bacteria.

Clinpro 5000 Anti-Cavity Toothpaste is supplied as a white dentifrice paste in a 4 oz. (113 gm) plastic tube (NDC 48878-3120-4 Vanilla Mint Flavor and NDC 48878-3130-4 Spearmint Flavor).

Storage

This product is designed to be stored and used at room temperature. Shelf life at room temperature is 24 months. Ambient temperatures routinely higher than 27C/80F, or lower than 10C/50F may reduce shelf life. See outer package for expiration date.

Manufactured for: 3M ESPE Dental Products3M CenterBuilding 275-2SE-03St. Paul, MN 55144-1000U.S.A.1-800-634-2249

Revision date: 09/24/2010 Rx Only44-0007-4699-8

3M, ESPE, and Clinpro are trademarks of 3M or 3M ESPE AG.© 3M 2010. All rights reserved.

3M ESPE

NDC 48878-3130-4

Clinpro™ 5000

Spearmint

1.1% Sodium Fluoride

Anti-Cavity Toothpaste

Innovative

Tri-Calcium

Phosphate

Exclusively from 3M ESPE

Contents: 1 Tube NET WT 4 oz (113g)

Rx Only

IMAGE cli08-0004-01.jpg

3M ESPE

NDC 48878-3130-4

Clinpro™ 5000

Spearmint

1.1% Sodium Fluoride

Anti-Cavity Toothpaste

Innovative

Tri-Calcium

Phosphate

Exclusively from 3M ESPE

Rx Only

NET WT 4 oz (113g)

IMAGE cli08-0004-02.jpg

Manufacturer

3M ESPE Dental Products

Active Ingredients

Source

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