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| Product NDC Code | 59883-031 | ||||||
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| Drug Name | Fluoridex |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | DENTAL | ||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||
| RxCUI drug identifier | 637365, 847014 |
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| Labeler Name | DENT-MAT HOLDINGS, LLC. | ||||||
| Packages |
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Overdosage of FLUORIDEX
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
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 rarely been reported.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY A treatment dose (a thin ribbon) of Fluoridex 5000 ppm sodium fluoride toothpaste contains 2.5 mg fluoride. A 4 oz. tube contains 566 mg fluoride. Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
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.
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 Fluoridex toothpaste is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries. Daily Defense Mint: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol. Daily Defense Fruit: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Red No. 33, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol. Enhanced Whitening Mint: Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Laurel Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol.
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 • Follow these instructions or use as instructed by a dental professional.• Adults and children age 6 or older, apply a thin ribbon or pea-sized amount of Fluoridex toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute. After use: • Adults should expectorate. For best results, do not eat, drink, or rinse for 30 minutes. • Children, age 6 to 16, should expectorate after use and rinse mouth thoroughly. • Use twice daily as your normal dentifrice or as directed by your dental professional.
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 3 DOSAGE FORMS AND STRENGTHS • Daily Defense Mint: Green toothpaste containing 1.1% Sodium Fluoride (Mint). (3) • Daily Defense Fruit: Pink toothpaste containing 1.1% Sodium Fluoride (Fruit). (3) • Enhanced Whitening Mint: Green toothpaste containing 1.1% Sodium Fluoride (Mint). (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 Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
Spl product data elements
Usually a list of ingredients in a drug product.FLUORIDEX Sodium Fluoride POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Clean Mint
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no cParcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body w eight) did not result in impaired fertility and reproductive capabilities.
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 NDC59883-031-04 FLUORIDEX SENSITIVITY RELIEF Prescription-Strength Anticavity Toothpaste CLEAN MINT 1.1% Sodium Fluoride 5000 PPM 5% Potassium Nitrate Net Wt. 4 oz. (112 g) Rx Only sensitive_mint
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION ____________________________ These highlights do not include all the information needed to use Fluoridex toothpaste safely and effectively. See full prescribing information. Fluoridex 1.1% Sodium Fluoride toothpaste for oral use INDICATIONS AND USAGE _______________________________________________ Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. (1) DOSAGE AND ADMINISTRATION _________________________________________ • Apply a thin ribbon or pea-sized amount of Fluoridex toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute. (2) • After use, adults should expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Children, age 6-16, should expectorate after use and rinse mouth thoroughly. (2) • Use twice daily as your normal dentifrice or as directed by your dental professional. (2) DOSAGE FORMS AND STRENGTHS ______________________________________ • Daily Defense Mint: Green toothpaste containing 1.1% Sodium Fluoride (Mint). (3) • Daily Defense Fruit: Pink toothpaste containing 1.1% Sodium Fluoride (Fruit). (3) • Enhanced Whitening Mint: Green toothpaste containing 1.1% Sodium Fluoride (Mint). (3) CONTRAINDICATIONS ___________________________________________________ Do not use in children under 6 years of age unless recommended by a dentist or physician. (4) WARNINGS AND PRECAUTIONS _________________________________________ ● DO NOT SWALLOW. (5) ● Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. (5) ● Repeated ingestion of high levels of fluoride may cause dental fluorosis. (5) ● Do not use this product longer than 4 weeks unless recommended by a dentist or physician. (5) ADVERSE REACTIONS ___________________________________________________ Allergic reactions and other idiosyncrasies have rarely been reported. (6) To report SUSPECTED ADVERSE REACTIONS, contact DenMat, at 1-800-752-2564, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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 1. American Dental Association, Council on Dental Therapeutics, Fluoride compounds, In: Accepted Dental Therapeutics, Ed. 40, Chicago, ADA, 405-407, (1984). 2. Englander HR, et al., Clinical Anticaries Effect of Repeated Topical Sodium Fluroide Applications by Mouthpieces, JADA, 75, 638-644, (1967). 3. Englander HR, et al., Residual Anticaries Effect of Repeated Topical Sodium Fluoride Applications by Mouthpieces, JADA, 78, 783-787 (1969). 4. Englander HR, et al: JADA, 83:354-358, 1971.
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 Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate or well controlled clinical studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. 8.3 Nursing Mothers It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. 8.4 Pediatric Use The use of Fluoridex toothpaste in children age 6-16 as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. 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. Please refer to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections. 8.5 Geriatric Use Subjects referenced in clinical studies of 1.1% (w/v) sodium fluoride, included 15 percent age 65 and over, with 1 percent age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger clients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in clients with impaired renal function. Because elderly clients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
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 4 oz. (112 g) net wt. tube • Daily Defense Mint NDC 59883-016-04 • Daily Defense Fruit NDC 59883-015-04 • Enhanced Whitening Mint NDC 59883-020-04 Store at controlled room temperature 15°-30° C (59°-86° F)
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