The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Ionite R (NDC 53045-266). 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 indications and usage, dosage form and strength, contraindications, warnings and precautions, adverse reactions, description, how supplied/storage, ionite r sodium fluoride rinse, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Liquid containing 2% sodium fluoride
Avoid use in patients with known hypersensitivity to fluoride
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 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.
2.0% Neutral Sodium Fluoride
Dye Free
Fruit Punch
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
www.dharmaresearch.com
NDC 53045-266-64
Label Revision B, 10/29/13
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