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| Product NDC Code | 53045-281 | ||||
|---|---|---|---|---|---|
| Drug Name | Ionite h |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 637365 | ||||
| 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. Do not use in pediatric patients under 12 unless directed by a dentist or physician.
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 H Neutral Fluoride Gel is a flavored, pH neutral 1.1% sodium fluoride, 5% potassium nitrate gel that aids in the prevention of dental decay and hleps to treat sensitive teeth.
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.DOSAGE AND ADMINISTRATION Use twice per day (morning and evening) in place of regular toothpaste or as recommended by a dentist or physician. Adults and children 12 years of age and older: Twist off cap and remove foil seal. Apply at least a 1 inch strip gel onto a soft bristle tooth brush. Brush teeth thoroughly for at least 1 minute, spit out, and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician.
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 FORMS AND STRENGTHS Gel containing 1.1% sodium fluoride and 5% potassium nitrate.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol
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 fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.
Spl product data elements
Usually a list of ingredients in a drug product.Ionite H Sodium Fluoride, Potassium Nitrate SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION .ALPHA.-TOCOPHEROL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETIC ACID GLYCERIN SODIUM HYDROXIDE SODIUM POLYMETAPHOSPHATE TRICALCIUM PHOSPHATE water 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 H NDC 53045-281-04 Home Care 1.1% Neutral Fluoride Gel with Xylitol and Vitamin E Bubble Gum Rx Only Made in USA Gluten Free Dye Free Re-order#: 56-00141 4.3 oz. (122 g) 20150802 281 NaFKNO3 BubGum RevA
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.Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel
ACTIVE INGREDIENTS Sodium Fluoride, 1.1%; Potassium Nitrate, 5%
Manufactured by Dharma Research, Inc. www.dharmaresearch.com 5220 N.W. 72 Avenue, Unit 15 Miami, FL 33166 1-877-833-3725
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 4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).
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