Fluoride
Sodium Fluoride
Puretek Corporation
Human Prescription Drug
NDC 59088-104Fluoride also known as Sodium Fluoride is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Fluoride is 59088-104. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Fluoride drug includes Sodium Fluoride - .25 mg/1 . The currest status of Fluoride drug is Active.
Drug Information:
| Drug NDC: | 59088-104 |
| 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: | Fluoride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Puretek Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| 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 - .25 mg/1
|
| 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 Jun, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Jan, 2026 |
| 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: | 31 Dec, 2023 |
| 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: | PureTek Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198215
|
| 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. |
| UPC: | 0731477391772
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 59088-104-73 | 120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-104-73) | 01 Jun, 2011 | N/A | 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. |
Product Elements:
Fluoride sodium fluoride sodium fluoride fluoride ion croscarmellose sodium d&c red no. 27 magnesium stearate mannitol microcrystalline cellulose sucrose cherry flavor 104 light pink
Drug Interactions:
Drug interactions do not eat or drink dairy products within one hour of fluoride administration. incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride, which is poorly absorbed.
Indications and Usage:
Indications and usage for once daily self-applied systemic use as a dental caries preventive in pediatric patients. it has been established that ingestion of fluoridated drinking water (1 ppm f*) during the period of tooth development results in a significant decrease in the incidence of dental caries. fluoride chewable tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm f*.
Warnings:
Warnings prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. read directions carefully before using. keep out of the reach of children.
Dosage and Administration:
Dosage and administration dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.
Contraindications:
Contraindications fluoride chewable tablets 0.25 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm f* and should not be administered to pediatric patients under 3 years of age when the fluoride content of drinking water is 0.3 ppm f* or more. do not administer fluoride chewable tablets (any strength) to pediatric patients under age 6 months.
Adverse Reactions:
Adverse reactions allergic rash and other idiosyncrasies have rarely been reported. call your doctor for medical advice about side effects. you may report side effects to the fda at 1 (800) fda-1088.
Drug Interactions:
Drug interactions do not eat or drink dairy products within one hour of fluoride administration. incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride, which is poorly absorbed.
Use in Pregnancy:
Pregnancy teratogenic effects: 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.
Pediatric Use:
Pediatric use the use of fluoride chewable tablets 0.25 mg as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies on fluoride supplementation from birth through adolescence.
Geriatric Use:
Geriatric use fluoride chewable tablets 0.25 mg are not indicated for use in geriatric patients.
Overdosage:
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) has 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) has 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.
Description:
Description each fluoride chewable tablet 0.25 mg is erythrosine (fd&c red dye no.3) free. each tablet contains 0.25 mg f* from 55 mg sodium fluoride (naf). each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.25 mg and the following inactive ingredients: cherry flavor, croscarmellose sodium, d&c red no. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sucrose.
Clinical Pharmacology:
Clinical pharmacology sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process.
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 for male rats treated with 2.5 mg and 4.1 mg 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. this dose is at least 400 times greater than the recommended daily dose of fluoride chewable tablets. 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 in which humans are exposed. in vivo data is conflicting. some studies report chromosome damage in rodents while other studies using similar protocols report negative results. potential adverse reproductive e
Read more...ffects 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 doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. this dose is approximately 200 times greater than the recommended daily dose of fluoride chewable tablets.
How Supplied:
How supplied chewable tablets containing 0.25 mg fluoride are pink-colored, cherry flavor, un-scored, round, debossed â104â. available in bottles of 120âs. ndc: 59088-104-73
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