Rorobell WaWa Tooth
Rorobell WaWa Tooth is an FDA drug label for the active ingredient SODIUM MONOFLUOROPHOSPHATE manufactured by ROROBELL 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 20260803.
- Generic name
- SODIUM MONOFLUOROPHOSPHATE
- Manufacturer
- ROROBELL
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 81275-010
- Application
- M021
- Label effective
- 20260803
About this product
Rorobell WaWa Tooth is an FDA-registered drug product whose active ingredient is SODIUM MONOFLUOROPHOSPHATE. It is labelled by ROROBELL taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 81275-010, application M021, label effective 20260803. It is one of 59 FDA drug label records sharing the active ingredient SODIUM MONOFLUOROPHOSPHATE. 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 MONOFLUOROPHOSPHATE are most often described in connection with: oral cavity, keeps teeth, clean freshens, helps prevent, removes bad, breath improves, prevents gingivitis, periodontitis pyorrhea. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses ■ Keeps teeth white and strong. ■ Keeps the oral cavity clean. ■ Freshens the oral cavity. ■ Helps prevent cavities with fluoride and removes bad breath. ■ Improves the appearance of teeth. ■ Prevents gingivitis, periodontitis (pyorrhea), periodontal disease, and gum disease. ■ Removes dental plaque (anti-plaque).
Dosage & Administration
Directions ■ Brush teeth thoroughly with an appropriate amount of toothpaste.
Warnings
WARNINGS ■ Contains 950 ppm of fluoride. ■ Do not swallow. Rinse your mouth thoroughly after use. ■ If you experience any problems with your gums or mouth during use, discontinue use and consult a physician or dentist. ■ Children under 6 years of age should use a small amount of toothpaste under adult supervision to minimize swallowing. ■ If a child under 6 years of age accidentally swallows a large a mount, consult a physician or dentist immediately. ■ Keep out of reach of children under 6 years of age.
More products with the same ingredient
SODIUM MONOFLUOROPHOSPHATEADVANCED WHITENING ANTI CAVITY FLUORIDE
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View labelCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT
View labelCOLGATE Baking Soda and Peroxide Whitening Brisk Mint
View labelCOLGATE Great Regular Flavor
View labelCOLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH
View labelCOLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE
View labelHow products containing SODIUM MONOFLUOROPHOSPHATE compare
FDA lists 59 drug label records with SODIUM MONOFLUOROPHOSPHATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Colgate-Palmolive Company | 17 |
| — | — | Tom's of Maine, Inc. | 14 |
| — | — | Universal Distribution Center LLC | 4 |
| — | — | White Glo USA Inc | 4 |
| — | — | Wessco International | 3 |
Frequently asked questions
What is Rorobell WaWa Tooth used for?
Uses ■ Keeps teeth white and strong. ■ Keeps the oral cavity clean. ■ Freshens the oral cavity. ■ Helps prevent cavities with fluoride and removes bad breath. ■ Improves the appearance of teeth. ■ Prevents gingivitis, periodontitis (pyorrhea), periodontal disease, and gum disease. ■ Removes dental plaque (anti-plaque).
Who makes Rorobell WaWa Tooth?
ROROBELL is the labeler of record for Rorobell WaWa Tooth. 59 FDA label records share the active ingredient SODIUM MONOFLUOROPHOSPHATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Rorobell WaWa Tooth 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 Rorobell WaWa Tooth 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.
Are there other products containing SODIUM MONOFLUOROPHOSPHATE?
Yes. 59 FDA drug label records list SODIUM MONOFLUOROPHOSPHATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Rorobell WaWa Tooth 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.