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Sodium Fluoride Drops | Sodium Fluoride [Method Pharmaceuticals, LLC] | BioPortfolio

13:36 EST 27th January 2019 | BioPortfolio

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SODIUM FLUORIDE- sodium fluoride solution/ drops

S odium Fluoride Drops 0.5 mg/mL

GRAPE FLAVORED

Each mL of Sodium Fluoride Drops contains 0.5 mg Fluoride ion (F) from 1.1 mg Sodium Fluoride (NaF). For use as a dental caries preventive in pediatric patients. Sugar Free, Alcohol Free, Dye Free and Gluten Free.

Supplement Facts

Serving Size: 1 mL

Servings Per Container: 50

      Amount per serving       % Daily Value

Fluoride (as Sodium Fluoride)                   0.5 mg             **

** Daily Value not established.

Active Ingredients: Sodium Fluoride (0.11% w/v).

Other Ingredients: Glycerin, methylparaben, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

* 1.0 ppm = 1 mg/Liter

† 1.1 mg Sodium Fluoride contains 0.5 mg Fluoride ion

Fluoride Supplement Dose Schedule approved by the American Dental Association, American Academy of Pediatrics and American Academy of Pediatric Dentistry.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF   CHILDREN.

FLUORIDE SUPPLEMENT DOSAGE SCHEDULES
AGE Fluoride Ion Level in Drinking Water (ppm)*
  < 0.3 ppm 0.3 - 0.6 ppm > 0.6 ppm
Birth to 6 months None None None
6 months to 3 years Half dropperful 0.25 mg F (1/2 mL) None None
3 to 6 years One dropperful 0.5 mg F (1 mL)† Half dropperful 0.25 mg F (1/2 mL) None
6 to 16 years Two dropperfuls 1 mg F (2 mL) One dropperful 0.5 mg F (1 mL) None

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.

As a supplemental source of Fluoride. It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries.1 Sodium Fluoride Drops were developed to provide systemic Fluoride for use as a supplement

in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water Fluoride level does not exceed 0.6 ppm F.

Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.

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 infants and children.

See "Overdosage" section. Incompatibility of Fluoride with dairy foods has been reported due to formation of Calcium Fluoride which is poorly absorbed. Not for use in the eyes.

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or Method Pharmaceuticals, LLC at 877-250-3427.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Prolonged daily ingestion of excessive Fluoride may result in varying degrees of dental fluorosis. The total amount of Sodium Fluoride in a bottle of 50 mL (0.5 mg/mL) Sodium Fluoride Drops (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes. If overdose is suspected, call 1-800-222-1222 (American Association of Poison Control Centers), your local poison control center (www.aapcc.org), or emergency room immediately for treatment recommendations.

Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F) age 6 months to 3 years: one half dropperful (1/2 mL); age 3 to 6 years, one dropperful (1 mL); age 6 to 16 years, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: age 6 months to 3 years, Fluoride supplementation not indicated; age 3 to 6 years, one half dropperful (1/2 mL); age 6 to 16 years, one dropperful (1 mL).

50 mL bottles (58657-322-50)

1. Accepted Dental Therapeutics, Ed. 40. American Dental

Association, Chicago, 1984:399-402.

2. Jakush, J, New Fluoride Schedule Adopted. ADA News.

May 16, 1994:12-14.

Manufactured by: Method Pharmaceuticals, LLCFort Worth, TX 76118

Rev. 07/2018

NDC 58657-322-50SodiumFluorideDropsSodium Fluoride Oral Solution, USP0.5 mg/mLGRAPE FLAVORED1.69 FL. OZ. (50 mL)

Manufacturer

Method Pharmaceuticals, LLC

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Clinical Trials [1981 Associated Clinical Trials listed on BioPortfolio]

Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

The study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who were referred to the investigators' clinic. Patients who completed dental treatment under ge...

In Situ Caries Model of Fluoride Toothpastes

This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model

Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices

The purpose of this study is to evaluate and compare the stain build up of two stannous fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels, with a m...

Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma

The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients con...

A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity

The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduc...

PubMed Articles [1964 Associated PubMed Articles listed on BioPortfolio]

Sodium fluoride and silver diamine fluoride-coated tooth surfaces inhibit bacterial acid production at the bacteria/tooth interface.

This study aimed to evaluate whether coating tooth surfaces with sodium fluoride (NaF) or silver diamine fluoride (SDF) inhibits bacteria-induced pH reductions at the bacteria/tooth interface.

Streptococcus mutans transcriptome in the presence of sodium fluoride and sucrose.

Considering the diverse mechanisms by which fluoride could affect oral bacteria, this study evaluated the effect of sodium fluoride onStreptococcus mutans transcriptome in the presence of sucrose.

Sodium Fluoride Arrests Renal G2/M Phase Cell-Cycle Progression by Activating ATM-Chk2-P53/Cdc25C Signaling Pathway in Mice.

Excessive fluoride intake can induce cytotoxicity, DNA damage and cell-cycle changes in many tissues and organs, including the kidney. However, the underlying molecular mechanisms of fluoride-induced ...

A Clinical Investigation of a Dual Zinc plus Arginine Dentifrice in Reducing Established Dental Plaque and Gingivitis Over a Six-Month Period of Product Use.

The objective of this single-center, double-blind, parallel-group, randomized six-month clinical study was to evaluate the clinical efficacy of a new Dual Zinc plus Arginine dentifrice (Colgate-Palmol...

Comparative cariostatic efficacy of a novel Nano-silver fluoride varnish with 38% silver diamine fluoride varnish a double-blind randomized clinical trial.

To evaluate the clinical cariostatic efficacy of a concocted 5% Nano-silver incorporated Sodium fluoride (NSSF) dental varnish with 38% Silver diamine fluoride (SDF) in preventing the progression of d...

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