Neutramaxx 5000 Tri-calcium Phosphate
Sodium Fluoride
Massco Dental A Division Of Dunagin Pharmaceuticals
Human Prescription Drug
NDC 63783-502Neutramaxx 5000 Tri-calcium Phosphate also known as Sodium Fluoride is a human prescription drug labeled by 'Massco Dental A Division Of Dunagin Pharmaceuticals'. National Drug Code (NDC) number for Neutramaxx 5000 Tri-calcium Phosphate is 63783-502. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Neutramaxx 5000 Tri-calcium Phosphate drug includes Sodium Fluoride - 1.1 g/112g . The currest status of Neutramaxx 5000 Tri-calcium Phosphate drug is Active.
Drug Information:
| Drug NDC: | 63783-502 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Neutramaxx 5000 Tri-calcium Phosphate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Neutramaxx 5000 |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Tri-Calcium Phosphate |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Massco Dental A Division Of Dunagin Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Paste, Dentifrice |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM FLUORIDE - 1.1 g/112g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Aug, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 21 Jan, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Massco Dental A Division of Dunagin Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 392038
1191716
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 8ZYQ1474W7
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63783-502-04 | 112 g in 1 TUBE (63783-502-04) | 01 Aug, 2011 | 31 Dec, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose for prevention of tooth decay, orthodontic decalcification and hypersensitivity.
Product Elements:
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
Indications and Usage:
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)
Warnings:
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
Dosage and Administration:
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.
Adverse Reactions:
Adverse reastions: allergic reaction and other idosyncrasies have been rarely reported.
Use in Pregnancy:
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.
Pediatric Use:
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.
Overdosage:
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.
Description:
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.
Clinical Pharmacology:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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 repo
Read more...rted 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.
How Supplied:
How supplies: 4 oz. (112 gm) net wt. tube
Package Label Principal Display Panel:
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
Further Questions:
Questions? comments? section call 1-479-787-5168 m-f 9am to 5 pm cst