Other
Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel
Manufactured by Dharma Research, Inc.
www.dharmaresearch.com
5220 N.W. 72 Avenue, Unit 15
Miami, FL 33166
1-877-833-3725
Ionite H Gel, Dentifrice
FDA Label NDC 53045-281
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Ionite H (NDC 53045-281). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, adverse reactions, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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
Gel containing 1.1% sodium fluoride and 5% potassium nitrate.
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.
Warnings And Precautions
Do not swallow.
Keep out of reach of children.
Read prescribing information fully before using this product. If product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away.
Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.
Do not use this product for longer than 4 weeks unless recommended by a dentist or physician.
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
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.
Active Ingredients
Sodium Fluoride, 1.1%; Potassium Nitrate, 5%
Inactive Ingredients
Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol
How Supplied/Storage
4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).
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)
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