sodium fluoride rinse
sodium fluoride rinse is an FDA drug label for the active ingredient SODIUM FLUORIDE RINSE manufactured by Rockland Cosmetics, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260520.
- Generic name
- SODIUM FLUORIDE RINSE
- Manufacturer
- Rockland Cosmetics, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69892-971
- Application
- M021
- Label effective
- 20260520
About this product
sodium fluoride rinse is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE RINSE. It is labelled by Rockland Cosmetics, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69892-971, application M021, label effective 20260520. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing SODIUM FLUORIDE RINSE are most often described in connection with: prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use aids in the prevention of dental cavities
Dosage & Administration
Directions Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor
Warnings
Warning for this product.
Adverse Reactions
Adverse Reactions Distributed by: Rockland Cosmetics, Inc. Hillburn, NY 10931 www.RocklandCosmetics.com Made in the U.S.A. with U.S. and foreign components. NSK New Square Kashrus
Frequently asked questions
What is sodium fluoride rinse used for?
Use aids in the prevention of dental cavities
Who makes sodium fluoride rinse?
Rockland Cosmetics, Inc. is the labeler of record for sodium fluoride rinse.
What form does sodium fluoride rinse come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is sodium fluoride rinse prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has sodium fluoride rinse been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.