Label: CLINPRO 5000- sodium fluoride paste, dentifrice
- NDC Code(s): 48878-3120-4
- Packager: 3M ESPE Dental Products
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Clinpro TM 5000 Anti-Cavity Toothpaste safely and effectively. See full prescribing information for Clinpro 5000 Anti-Cavity Toothpaste.
Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste
Initial U.S. Approval: None
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. (1)
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. (2)
DOSAGE FORMS AND STRENGTHS
White toothpaste containing 1.1% sodium fluoride (3)
Do not use in children under 6 years of age unless recommended by a dentist or physician. (4)
WARNINGS AND PRECAUTIONS
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
- FULL PRESCRIBING INFORMATION: CONTENTS*
- Sections or subsections omitted from the full prescribing information are not listed.
- 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.Close
- 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.Close
- 3 DOSAGE FORMS AND STRENGTHS
White toothpaste containing 1.1% sodium fluorideClose
- 4 CONTRAINDICATIONS
Do not use in children under 6 years of age unless recommended by a dentist or physician.Close
- 5 WARNINGS AND PRECAUTIONS
• 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.Close
- 6 ADVERSE REACTIONS
Allergic reactions and other idiosyncrasies have been rarely reported.Close
- 8 USE IN SPECIFIC POPULATIONS
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.
- 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 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. *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.
- 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.Close
- 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.Close
- 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.
- 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).
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.
St. Paul, MN 55144-1000
Revision date: 09/15/08
3M, ESPE, and Clinpro are trademarks of 3M or 3M ESPE AG.
© 3M 2008. All rights reserved.
- Principal Display Panel – Box Label
1.1% Sodium Fluoride
Exclusively from 3M ESPE
Contents: 1 Tube NET WT 4 oz (113g)
- Principal Display Panel – Tube Label
1.1% Sodium Fluoride
Exclusively from 3M ESPE
NET WT 4 oz (113g)Close
- INGREDIENTS AND APPEARANCE
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48878-3120 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) sodium fluoride 11 mg in 1 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) silicon dioxide (UNII: ETJ7Z6XBU4) glycerin (UNII: PDC6A3C0OX) polyethylene glycol (UNII: 3WJQ0SDW1A) sodium lauryl sulfate (UNII: 368GB5141J) titanium dioxide (UNII: 15FIX9V2JP) carboxymethylcellulose sodium (UNII: K679OBS311) saccharin sodium (UNII: SB8ZUX40TY) tricalcium phosphate (UNII: K4C08XP666) Product Characteristics Color Score Shape Size Flavor MINT (MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48878-3120-4 1 in 1 BOX 1 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2009 Labeler - 3M ESPE Dental Products (799975909)