Sodium Fluoride And Potassium Nitrate
Westminster Pharmaceuticals, Llc
Human Prescription Drug
NDC 69367-318Sodium Fluoride And Potassium Nitrate is a human prescription drug labeled by 'Westminster Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Fluoride And Potassium Nitrate is 69367-318. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Sodium Fluoride And Potassium Nitrate drug includes Potassium Nitrate - 57.5 mg/mL Sodium Fluoride - 5.8 mg/mL . The currest status of Sodium Fluoride And Potassium Nitrate drug is Active.
Drug Information:
| Drug NDC: | 69367-318 |
| 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: | Sodium Fluoride And Potassium Nitrate |
| 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 And Potassium Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Westminster Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | POTASSIUM NITRATE - 57.5 mg/mL
SODIUM FLUORIDE - 5.8 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| 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: | 15 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| 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: | Westminster Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 637365
|
| 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: | 0369367318013
|
| UPC stands for Universal Product Code. |
| UNII: | RU45X2JN0Z
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 |
|---|
| 69367-318-01 | 1 TUBE in 1 CARTON (69367-318-01) / 100 mL in 1 TUBE | 15 Jun, 2022 | 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:
Sodium fluoride and potassium nitrate sodium fluoride and potassium nitrate sodium fluoride fluoride ion potassium nitrate nitrate ion water sodium benzoate saccharin sodium titanium dioxide sodium pyrophosphate sorbitol fd&c blue no. 1 fd&c yellow no. 6 hydrated silica glycerin 1-methyl ether glycerin 2-methyl ether xanthan gum sodium lauryl sulfate
Indications and Usage:
Indications and usage a dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adult patients and children 12 years of age and older. 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 sodium fluoride 5000 ppm sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush. this prescription toothpaste should be used twice 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 fluorosis. (see warnings for exception.)
Warnings:
Warnings not for systemic treatment - do not swallow. keep out of the reach of children. children under 12 years of age, consult a dentist or physician. note: sensitive teeth may indicate a serious problem that may need prompt care by a dentist. see your dentist if the problem persists or worsens. do not use this product longer than 4 weeks unless recommended by a dentist or physician.
General Precautions:
General not for systemic treatment. do not swallow.
Dosage and Administration:
Dosage and administration follow these instructions unless otherwise instructed by your dental professional: adults and children 12 years of age or older, apply at least a 1 inch strip of sodium fluoride 5000 ppm sensitive onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. use twice daily, (morning and evening) or as recommended by a dentist or physician. make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or physician.
Contraindications:
Contraindications do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
Adverse Reactions:
Adverse reactions allergic reactions and other idiosyncrasies have been rarely reported. to report suspected adverse reactions, contact westminster pharmaceuticals, llc at 1-844-221-7294 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
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. there are no adequate and well-controlled 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.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients below the age of 12 years have not been established. please refer to the contraindications and warnings sections.
Geriatric Use:
Geriatric use no studies of sodium fluoride 5000 ppm sensitive have been conducted to determine whether subjects aged 65 and over respond differently from younger subjects.
Overdosage:
Overdosage accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. nausea, vomitting, 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 vomitting, 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 vomitting and admit immediately to a hospital facility. a treatment dose (a thin ribbon) of sodium fluoride 5000 ppm sensitive contains approximately 2.5 mg fluoride. a 3.4 fl oz (100 ml) tube contains approximately 575 mg fluoride.
Description:
Description self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate. active ingredients sodium fluoride 1.1% (w/w) potassium nitrate 5% inactive ingredients fd&c blue no.1, fd&c yellow, glycerin-1, glycerin-2, hydrated silica, peppermint, purified water, sls (stepanol wa 100), sodium benzoate, sodium saccharin, sorbitol 70%, tetrasodium pyrophosphate, titanium dioxide, xanthum gum.
Clinical Pharmacology:
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.
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 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
Read more... 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.
How Supplied:
How supplied 3.4 fl oz (100ml) net wt. tube ndc 69367-318-01 mild mint storage store at controlled room temperature, 20°-25°c (68°-77°f)
Package Label Principal Display Panel:
Principal display panel - 100 ml tube carton mild mint ndc 69367-318-01 rx only sodium fluoride 5000 ppm sensitive 1.1% sodium fluoride, 5% potassium nitrate prescription strength toothpaste for sensitive teeth 3.4 fl oz (100 ml) westminster pharmaceuticals principal display panel - 100 ml tube carton