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These highlights do not include all the information needed to use 3M ESPE Clinpro 5000 Anti-Cavity Toothpaste safely and effectively. See full prescribing information for Clinpro 5000 Anti-Cavity Toothpaste.3M ESPE Clinpro 5000 1.1% Sodium Fluoride Anti-C | Clinpro 5000 [3M ESPE Dental Products] | BioPortfolio

12:35 EST 27th January 2019 | 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.

• 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.

White toothpaste containing 1.1% sodium fluoride

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

• DO NOT SWALLOW. If more than a pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste is swallowed, contact a medical or dental professional or a poison control center.

• Keep out of reach of children under 6 years of age.

• Repeated ingestion of high levels of fluoride may cause dental fluorosis. For this reason, use in children with developing dentition requires special supervision to prevent swallowing. Prescribing dentists and physicians should consider risk of fluorosis when prescribing for use in children less than 6 years of age.

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.

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 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.

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; NDC 48878-3130-4 Spearmint Flavor; NDC 48878-3140-4 Bubble Gum Flavor).

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 Products2510 Conway AvenueSt. Paul, MN 55144-1000 USARevision date: 01/11/2012

Rx Only

3M, ESPE, and Clinpro are trademarks of 3M or 3M Deutschland GmbH.© 3M 2016. All rights reserved.

Principal Display Panel – Box Label

3M ESPE

NDC 48878-3120-4

Clinpro™ 5000

Vanilla Mint

1.1% Sodium Fluoride

Anti-Cavity Toothpaste

Innovative

Tri-Calcium

Phosphate

Exclusively from 3M ESPE

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

Rx Only

Principal Display Panel – Box Label

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 4oz (113g)

Rx Only

Principal Display Panel – Box Label

3M ESPE

NDC 48878-3140-4

Clinpro™ 5000

Bubble Gum

1.1% Sodium Fluoride

Anti-Cavity Toothpaste

Innovative

Tri-Calcium

Phosphate

Exclusively from 3M ESPE

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

Rx Only

Manufacturer

3M ESPE Dental Products

Active Ingredients

Source

Clinical Trials [98 Associated Clinical Trials listed on BioPortfolio]

Comparison of Three Toothpastes for the Prevention and Reduction of White Spot Lesions

The purpose of the study is to determine if Clinpro™ 5000, Clinpro™ Tooth Crème, or MI-Paste Plus has an effect on the formation and resolution of white spot lesions for patients unde...

Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars

This study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and fis...

RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment

evaluate the effect of a single application of Clinpro XT varnish on enamel demineralization adjacent to orthodontic brackets during fixed orthodontic treatment in comparison with acidulat...

Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment

The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination...

Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions

to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare...

PubMed Articles [168 Associated PubMed Articles listed on BioPortfolio]

Remineralizing Potential of Clinpro and Tooth Mousse Plus on Artificial Carious Lesions.

Calcium phosphate and fluoride (F) delivery systems claim to facilitate enamel remineralization.

Modification of a steel fiber with a graphene based bucky gel for headspace solid-phase microextraction of volatile aromatic hydrocarbons prior to their quantification by GC.

A graphene based bucky gel-coated stainless steel fiber was prepared and applied to headspace solid phase microextraction of volatile organic compounds. Graphene was mixed with an ionic liquid to prod...

Does magnification of SEM image influence quantification of particulate matters deposited on vegetation foliage.

The metrics used to quantify the particles on the leaf surface can serve as indicators for the quality of the atmospheric environment and is employed to evaluate the ecosystem services that plants can...

Analytical performance evaluation of the new GEM® Premier™ 5000 analyzer in comparison to the GEM® Premier™ 4000 and the RapidPoint® 405 systems.

Blood gas analysis (BGA) is essential for the diagnosis and management of acid-base imbalances. We evaluated and compared the analytical characteristics of the new GEM® Premier™ 5000 (GP5000) (Inst...

Analysis of running stability during 5000 m running.

In the analysis of human walking, the assessment of local dynamic stability (LDS) has been widely used to determine gait stability. To extend the concepts of LDS to the analysis of running biomechanic...

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