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| Product NDC Code | 48878-3120 | ||||
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| Drug Name | Clinpro 5000 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 392038, 1006558 |
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| Labeler Name | Solventum US OpCo LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Clinpro 5000
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE 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.
| 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. | ||
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.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 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION 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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS White toothpaste containing 1.1% sodium fluoride White toothpaste containing 1.1% sodium fluoride ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 )
Spl product data elements
Usually a list of ingredients in a drug product.Clinpro 5000 sodium fluoride sodium fluoride fluoride ion Water Sorbitol Silicon Dioxide Glycerin Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Titanium Dioxide Carboxymethylcellulose Sodium Saccharin Sodium Tricalcium Phosphate MINT Clinpro 5000 sodium fluoride sodium fluoride fluoride ion Water Sorbitol Silicon Dioxide Glycerin Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Titanium Dioxide Carboxymethylcellulose Sodium Saccharin Sodium Tricalcium Phosphate SPEARMINT Clinpro 5000 sodium fluoride sodium fluoride fluoride ion Water Sorbitol Silicon Dioxide Glycerin Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Titanium Dioxide Carboxymethylcellulose Sodium Saccharin Sodium Tricalcium Phosphate BUBBLE GUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
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
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 Principal Display Panel – Box Label
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.15 REFERENCES National Research Council. Fluoride in drinking water: A scientific review of EPA's standards; National Academies Press 2006. IOM. Dietary Reference Intakes: The essential guide to nutrient requirements. National Academies Press 2006. Heindel JJ, et al. Developmental toxicity evaluation of sodium fluoride administered to rats and rabbits in drinking water. Fundam Appl Toxicol 1996;30(2):162-177. Poisindex. Toxicologic Management – Fluoride. Thomson Micromedex.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.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.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.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.
| 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 |
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.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.
| 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 |
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING 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 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.
Storage and handling
Information about safe storage and handling of the drug product.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API