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Ionite R

Generic: Sodium Fluoride

Verified·Apr 23, 2026
Manufacturer
Pascal International
NDC
53045-265
RxCUI
251960
Route
DENTAL
ICD-10 indication
Z29.3

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About Ionite R

Ionite R is a prescription-strength oral rinse concentrate containing 0.63% stannous fluoride, primarily indicated for the prevention of dental caries, control of gingival inflammation, and relief of dentinal hypersensitivity. It works by remineralizing tooth enamel, inhibiting the metabolic activity of plaque bacteria, and occluding dentinal tubules to reduce sensitivity. Unlike tray-applied gels, this medication is typically diluted with water and used as a daily rinse.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Ionite R. Official source: DailyMed (NLM) · Label effective Nov 6, 2020

Indications and usage
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.
Contraindications
CONTRAINDICATIONS Avoid use in patients with known hypersensitivity to fluoride
Warnings and precautions
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.
Adverse reactions
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

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Prior authorization & coverage

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Medicare Part D

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.