Generic Name: sodium fluoride
Dosage Form: oral liquid
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.
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.
DOSAGE FORM AND STRENGTH
Liquid containing 2% sodium fluoride
Avoid use in patients with known hypersensitivity to fluoride
Warnings and Precautions
Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.
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 R 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
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.
Ionite R Sodium Fluoride Rinse
2.0% Neutral Sodium Fluoride
64 fl. oz. (1.9 L)
Dharma Research, Inc., 5220 NW 72nd Avenue, Unit 15, Miami, FL, 33166
Label Revision B, 10/29/13
sodium fluoride liquid
|Labeler - Dharma Research, Inc. (078444642)|
|Registrant - Dharma Research, Inc. (078444642)|
|Dharma Research, Inc.||078444642||manufacture(53045-266)|