ROROBELL WAWA Gum Care Tooth

ROROBELL WAWA Gum Care Tooth is an FDA-registered drug product whose active ingredient is HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE. It is labelled by ROROBELL taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 81275-011, label effective 20260803. It is one of 2 FDA drug label records sharing the active ingredient HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE. 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.

Across FDA labelling, products containing HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE are most often described in connection with: oral cavity, helps prevent, keeps teeth, clean refreshes, fluoride removes, bad breath, aesthetic effect, gingivitis periodontitis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ■ Keeps teeth white and strong. ■ Keeps the oral cavity clean. ■ Refreshes the oral cavity. ■ Helps prevent cavities with fluoride. ■ Removes bad breath. ■ Enhances the aesthetic effect. ■ Helps prevent gingivitis, periodontitis (pyorrhea), and periodontal disease. ■ Removes dental plaque (anti-plaque).

Directions ■ Brush teeth thoroughly with an appropriate amount of toothpaste.

Warnings ■ The fluoride concentration of this toothpaste is 1,450 ppm. ■ Do not swallow. Rinse your mouth thoroughly after use. ■ If irritation or any abnormality occurs, such as damage to the gums or inside of the mouth, discontinue use and consult a physician or dentist. ■ For children 6 years of age and under, use only a pea-sized amount under adult supervision to minimize swallowing. Do not allow the child to suck or swallow the toothpaste. ■ If a child 6 years of age and under accidentally swallows a large amount, consult a physician or dentist immediately. ■ Keep out of reach of children 6 years of age and under. ■ This toothpaste contains more than 1,000 ppm fluoride. Consult a physician or dentist before use by children 6 years of age and under.

FDA lists 2 drug label records with HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE 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.

What is ROROBELL WAWA Gum Care Tooth used for?
Uses ■ Keeps teeth white and strong. ■ Keeps the oral cavity clean. ■ Refreshes the oral cavity. ■ Helps prevent cavities with fluoride. ■ Removes bad breath. ■ Enhances the aesthetic effect. ■ Helps prevent gingivitis, periodontitis (pyorrhea), and periodontal disease. ■ Removes dental plaque (anti-plaque).

Who makes ROROBELL WAWA Gum Care Tooth?
ROROBELL is the labeler of record for ROROBELL WAWA Gum Care Tooth. 2 FDA label records share the active ingredient HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, 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 Gum Care 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 Gum Care 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 HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE?
Yes. 2 FDA drug label records list HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE 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 Gum Care 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.