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Closys fluoride rinse - Medication Information

Product NDC Code 58578-1234
Drug Name

Closys fluoride rinse

Type Brand
Active Ingredients
Sodium fluoride .05 g/100ml
Route ORAL
Dosage Form RINSE
RxCUI drug identifier 240698
Application Number M021
Labeler Name Rowpar Pharmaceuticals, Inc.
Packages
Package NDC Code Description
58578-1234-1 1 bottle in 1 box (58578-1234-1) / 473 ml in 1 bottle
58578-1234-2 100 ml in 1 bottle (58578-1234-2)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS: Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit out · do not swallow the rinse · do not eat or drink for 30 minutes after rinsing • instruct children under 12 years of age in good rinsing habits (to minimize swallowing) · supervise children as necessary until capable of using without supervision · Children under 6 years of age: consult a dentist or doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
USE: Aids in the prevention of dental cavities

Purpose

Information about the drug product’s indications for use.
PURPOSE Anticavity

Spl product data elements

Usually a list of ingredients in a drug product.
CloSYS Fluoride Rinse Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER CHLORINE DIOXIDE SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE ANHYDROUS CITRIC ACID PEPPERMINT SUCRALOSE 473 mL Bottle Label Carton Label 100 mL Bottle Label

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Packaging 473ml Inner Label 473 mL Carton 100 ml Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
OTHER INFORMATION: Do not use if safety seal is broken or missing

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-800-643-3337

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNING:

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API