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| Product NDC Code | 53045-265 | ||||
|---|---|---|---|---|---|
| Drug Name | Ionite r |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL, ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 251960 | ||||
| Labeler Name | Dharma Research, Inc. | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Avoid use in patients with known hypersensitivity to fluoride
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Ionite R Fluoride Oral Rinse is a flavored, pH neutral 2.0% sodium fluoride treatment rinse that aids in the prevention of dental decay. ACTIVE INGREDIENT: Sodium Fluoride, 2.0% INACTIVE INGREDIENTS: Flavor, Water, Sodium Benzoate, Sodium Citrate, Saccharin Sodium, Xylitol
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.DOSAGE FORM AND STRENGTH Liquid containing 2% sodium fluoride
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.INDICATIONS AND USAGE This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
Spl product data elements
Usually a list of ingredients in a drug product.Ionite R Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION Water SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM XYLITOL
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.Ionite R Sodium Fluoride Rinse 2.0% Neutral Sodium Fluoride Dye Free Spearmint With Xylitol Gluten Free Rx Only 64 fl. oz. (1.9 L) Manufactured by: Dharma Research, Inc., 5220 NW 72nd Avenue, Unit 15, Miami, FL, 33166 1-877-833-3725 NDC 53045-265-64 Label Revision B, 10/29/13 20131101FluorideRinseSpmnt
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED/STORAGE 64 fluid ounces (1.9 L) in a plastic bottle with dispensing pump included. Store at room temperature 59-86°F (15-30°C). Protect from freezing.
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