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| Product NDC Code | 64980-306 | ||||
|---|---|---|---|---|---|
| Drug Name | Denta 5000 plus |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 392038, 630196 |
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| Labeler Name | Rising Pharmaceuticals, Inc. | ||||
| Packages |
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Overdosage of Denta 5000 Plus
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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 emesis, 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. A treatment dose (a thin ribbon) of Denta 5000 Plus contains 2.5 mg fluoride. A 1.8 oz. tube contains 255 mg fluoride.
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.ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 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.CLINICAL PHARMACOLOGY: 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.CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years 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.DESCRIPTION: Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients.
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.DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Denta 5000 Plus to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16, expectorate after use and rinse mouth thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Sorbitol, Hydrated Silica, Glycerin, Tetrapotassium Pyrophosphate, Flavor, PEG 12, Sodium Lauryl Sulfate, Carboxymethylcellulose Gum, Sodium Saccharin, Titanium Dioxide, FD&C Blue #1
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.INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Denta 5000 Plus brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Spl product data elements
Usually a list of ingredients in a drug product.Denta 5000 Plus Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POTASSIUM PYROPHOSPHATE POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE TITANIUM DIOXIDE FD&C BLUE NO. 1 SACCHARIN SODIUM Denta 5000 Plus Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POTASSIUM PYROPHOSPHATE POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE TITANIUM DIOXIDE FD&C BLUE NO. 1 SACCHARIN SODIUM
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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 carcinogenesis 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 has 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 weight) 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 - 51 g Tube Rising NDC 64980-305-50 Denta 5000 Plus 1.1% SODIUM FLUORIDE Prescription Dental Cream 5000 ppm Fluoride Plus Mild Cleaning System Spearment NET WT. 1.8 OZ (51 g) Rx only PRINCIPAL DISPLAY PANEL - 51 g Tube Rising NDC 64980-306-50 2-Pack 2 x 1.8 OZ Tubes Denta 5000 Plus 1.1% SODIUM FLUORIDE Prescription Dental Cream 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 2 x 1.8 OZ (51 g) Rx only Denta-5000-Plus-2-pack-Carton Denta-5000-Plus-51g-Carton
PRINCIPAL DISPLAY PANEL - 51 g Tube Rising NDC 64980-306-50 2-Pack 2 x 1.8 OZ Tubes Denta 5000 Plus 1.1% SODIUM FLUORIDE Prescription Dental Cream 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 2 x 1.8 OZ (51 g) Rx only Denta-5000-Plus-2-pack-Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DENTA 5000 PLUS BRAND OF 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM
Active Ingredient: Sodium Fluoride 1.1% (w/w)
Rx only
Distributed by: Rising Pharmaceuticals, Inc. Manufactured by: Sheffield Pharmaceuticals, LLC Saddle Book, NJ 07663 New London, CT 06320 Revision Date: 9/18
| Rising Pharmaceuticals, Inc. | Sheffield Pharmaceuticals, LLC | ||||
| Saddle Book, NJ 07663 | New London, CT 06320 | ||||
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.REFERENCES: Accepted Dental Therapeutics, Ed. 40, ADA, Chicago. P. 405-407, 1984. Englander HR, Keyes et al: JADA 75:638-644, 1967. Englander HR, et al: JADA 78:783-787, 1969. Englander HR, et al: JADA 83:354-358, 1971.
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.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.
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.Pediatric Use: The use of Denta 5000 Plus in pediatric age groups 6 to 16 years 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. 2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
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.)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 tissue. 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. 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.
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.HOW SUPPLIED: Spearment 1.8 oz. (51g) net wt. tube (2) 1.8 oz. (51g) net wt. tubes (twin pack) NDC# 64980-305-50 NDC# 64980-306-50 STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F)
| 1.8 oz. (51g) net wt. tube (2) 1.8 oz. (51g) net wt. tubes (twin pack) | NDC# 64980-305-50 NDC# 64980-306-50 |
Storage and handling
Information about safe storage and handling of the drug product.STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F)
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS: Not for systemic treatment. DO NOT SWALLOW. 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 carcinogenesis 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 has 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 weight) did not result in impaired fertility and reproductive capabilities. 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 tissue. 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. 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. 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. Pediatric Use: The use of Denta 5000 Plus in pediatric age groups 6 to 16 years 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. 2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently can not perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the dental cream, which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.
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