Generic Name: sodium fluoride, potassium nitrate
Dosage Form: gel, dentifrice
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel
Indications and Usage for Ionite H
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.
Ionite H 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.
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.
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
Ionite H 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.
Sodium Fluoride, 1.1%; Potassium Nitrate, 5%
Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol
4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).
Manufactured by Dharma Research, Inc.
5220 N.W. 72 Avenue, Unit 15
Miami, FL 33166
1.1% Neutral Fluoride Gel
with Xylitol and Vitamin E
Made in USA
Gluten Free Dye Free
4.3 oz. (122 g)
sodium fluoride, potassium nitrate gel, dentifrice
|Labeler - Dharma Research, Inc. (078444642)|
|Dharma Research, Inc.||078444642||manufacture(53045-281)|