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| Product NDC Code | 63783-502 | ||||
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| Drug Name | Neutramaxx 5000 tri-calcium phosphate |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 392038, 1191716 |
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| Labeler Name | Massco Dental A Division of Dunagin Pharmaceuticals | ||||
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Overdosage of NEUTRAMAXX 5000 Tri-Calcium Phosphate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSE: Accidential ingestion of large amounts of fluoride may result in acute burning of the mouth and sore tongue. Nausea, vomiting and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salvation, hematemesis and epigastric cramping and abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg of body weight (i.e. less than 2.3 mg fluoride/kg of body weight) have been ingested, induce emesis, give oral soluble calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more that 15 mg fluoride/kg of body weight (i.e. more than 6.9 mg fluoride/kg of 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.ADVERSE REASTIONS: Allergic reaction and other idosyncrasies have been rarely reported.
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 increases tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients 1.1 % Neutral Sodium Floride
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 preventive 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: Directions: Use As Directed This prescription dentifrice is recommended for adults and pediatric patients 6 years and older Apply a thin ribbon of NeutraMaxxtm 5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes. After brushing ADULTS - Expectorate, do not eat for 30 minutes. CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water. Rinse mouth thoroughly. Use at bedtime in place of your regular toothpaste or as directed by your dental professional. Follow these instructions unless otherwise instructed by you dental professional.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Filtered Water, Sorbitol, Hydrated Silica, Glycerin, PEG 8000, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Vanilla Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate
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: NeutraMaxx™ 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity 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 NeutalMaxx™ 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 whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorisis. (See WARNINGS for exceptions)
Purpose
Information about the drug product’s indications for use.Purpose For prevention of tooth decay, orthodontic decalcification and hypersensitivity.
Spl product data elements
Usually a list of ingredients in a drug product.NEUTRAMAXX 5000 Tri-Calcium Phosphate SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 8000 CARBOXYMETHYLCELLULOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE TITANIUM DIOXIDE SACCHARIN SODIUM TRIBASIC CALCIUM PHOSPHATE VANILLA MINT
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 carcinogensesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of boby weight. Epidemiological data provide no credible evidence for an assocoation between Fluoride, either naturally occuring or added to drinking water, and the 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. Invivo data 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 (5mg/kg of body weight) do not resule 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.NeutraMaxxC TCP VANILLA MINT NDS 63783 63783-502-04 VANILLA MINT FLAVOR ANTI-CAVITY TOOTHPASTE XYLITOL NeutraMaxx™ 5000 TRI-CALCIUM PHOSPHATE 1.1% Neutral Sodium Fluoride 5000 ppm Sweetened with Xylitol DOES NOT CONTAIN SODIUM LAURYL SULFATE RX ONLY Net wt. 4 oz (112 G) Manufactured By: MASSCO DENTAL A Division of Dunagin Pharmaceuticals, Rogers, AR 800-227-1296 • www.masscodental.net MasscoNeutraMaxTCP 502-1.jpg MasscoNeutraMaxTCP 502-2.jpg
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children. As with all medications, keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Comments? Section Call 1-479-787-5168 M-F 9am to 5 pm CST
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 product 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 high concentration of fluoride (96-137 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 NeutraMaxx™ in pediatric age group 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium Fluoride gets 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 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 Catagory B. It has shown that fluoride crosses the placenta of rats, bot only 0.01% of the amount administered in 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 body weight (rabbits) did not affect the litter size of fetal weight and did not increase the frequency of sheletal or visceral malformations. Epidemiologiical studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during 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 SUPPLIES: 4 oz. (112 gm) net wt. tube
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.
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 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot preform the brushing process without significant swallowing. Use in pediatric patients under 6 years requires special supervision to prevent repeated swallowing of the cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children. Warnings Do not swallow For topical use only As with all medications, keep out of reach of 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