Sf
1.1% Sodium Fluoride
Cypress Pharmaceutical, Inc.
Human Prescription Drug
NDC 60258-151Sf also known as 1.1% Sodium Fluoride is a human prescription drug labeled by 'Cypress Pharmaceutical, Inc.'. National Drug Code (NDC) number for Sf is 60258-151. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Sf drug includes Sodium Fluoride - 11 mg/g . The currest status of Sf drug is Active.
Drug Information:
| Drug NDC: | 60258-151 |
| 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: | Sf |
| 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: | 1.1% Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cypress Pharmaceutical, Inc. |
| 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: | SODIUM FLUORIDE - 11 mg/g
|
| 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: | 01 Dec, 1999 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 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: | Cypress Pharmaceutical, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 392038
|
| 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 |
|---|
| 60258-151-01 | 1 TUBE in 1 CARTON (60258-151-01) / 56 g in 1 TUBE | 01 Dec, 1999 | 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:
Sf 1.1% sodium fluoride sodium fluoride fluoride ion hydroxyethyl cellulose (140 mpa.s at 5%) saccharin sodium methylparaben sorbitol water poloxamer 407 propylparaben fd&c blue no. 1 fresh mint
Indications and Usage:
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 sf 1.1% brush-on gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. this prescription dental gel should be used once daily following use of a 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 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 perform the brushing process without significant swallowing. use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel which could cause dental fluorosis. read directions carefully before using. if using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. keep this product out of the reach of children. in case of accidental overdosage, seek professional assistance or contact a poison control center immediately.
Dosage and Administration:
Dosage and administration follow these instructions unless otherwise instructed by your dental professional: 1. after brushing thoroughly with toothpaste, rinse as usual. adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime. 2. after use, adults expectorate gel. for the best results, do not eat, drink, or rinse for 30 minutes. pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly.
Contraindications:
Contraindications do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Adverse Reactions:
Adverse reactions allergic reactions and other idiosyncrasies have been rarely reported.
Use in Pregnancy:
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 in utero development may result in skeletal fluorosis which becomes evident in childhood.
Pediatric Use:
Pediatric use the use of sf 1.1% brush-on gel 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.
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 and 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 sf 1.1% brush-on gel contains 2 mg flouride. a 2 oz. tube contains 266 mg fluoride.
Description:
Description self-topical neutral fluoride gel containing 1.1% (w/v) sodium fluoride for use as a dental caries preventive in pediatric patients and adults. this prescription product is not a dentifrice. active ingredient: sodium fluoride, usp 1.1% (w/v).
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 2 oz. (56g) net wt. plastic tube. flavor: fresh mint ndc 60258-151-01
Package Label Principal Display Panel:
Principal display panel - 56 g tube carton fresh mint rx only ndc 60258-151-01 sf 1.1% gel 1.1% sodium fluoride brush-on gel (non-abrasive formula) cypress pharmaceutical, inc. net wt. 2 oz. (56 g) principal display panel - 56 g tube carton