ROROBELL WAWA Kids Tooth Natural Green Grape Flavor

HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE ORAL HUMAN OTC DRUG

ROROBELL WAWA Kids Tooth Natural Green Grape Flavor is an FDA drug label for the active ingredient HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE 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 20260806.

Generic name
HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE
Manufacturer
ROROBELL
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
81275-015
Application
N/A
Label effective
20260806

About this product

ROROBELL WAWA Kids Tooth Natural Green Grape Flavor 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 81275-015, label effective 20260806. 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.

What it is used for

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

Active ingredients

Active ingredients Hydrated Silica 13.0% Sodium Fluoride 0.22% Tocopheryl Acetate 0.20%

Indications & Usage

Uses ■ Keeps teeth white and strong. ■ Keeps the oral cavity clean. ■ Refreshes the oral cavity. ■ Prevents cavities by fluoride and removes bad breath. ■ Enhances the aesthetic effect. ■ Helps prevent gingivitis, periodontitis (pyorrhea), periodontal disease, and gum disease. ■ Prevention of tartar deposition. ■ Removes dental plaque (anti-plaque).

Dosage & Administration

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

Warnings

Warnings ■ This toothpaste contains 1,000 ppm fluoride. ■ Stop use and ask a doctor or dentist if irritation or other adverse reactions occur in the gums or mouth. ■ If more than the amount used for brushing is accidentally swallowed by a child under 6 years of age, get medical help or contact a Poison Control Center right away. ■ Do not swallow. Rinse mouth thoroughly after brushing. ■ Children under 6 years of age should use only a pea-sized amount under adult supervision to minimize swallowing. ■ Keep out of reach of children under 6 years of age

More products with the same ingredient

HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE

ROROBELL WAWA Gum Care Tooth

ROROBELL View label

How products containing HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE compare

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.

Dosage formProductsManufacturerProducts
— — ROROBELL 2
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Frequently asked questions

What is ROROBELL WAWA Kids Tooth Natural Green Grape Flavor used for?
Uses ■ Keeps teeth white and strong. ■ Keeps the oral cavity clean. ■ Refreshes the oral cavity. ■ Prevents cavities by fluoride and removes bad breath. ■ Enhances the aesthetic effect. ■ Helps prevent gingivitis, periodontitis (pyorrhea), periodontal disease, and gum disease. ■ Prevention of tartar deposition. ■ Removes dental plaque (anti-plaque).

Who makes ROROBELL WAWA Kids Tooth Natural Green Grape Flavor?
ROROBELL is the labeler of record for ROROBELL WAWA Kids Tooth Natural Green Grape Flavor. 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 Kids Tooth Natural Green Grape Flavor 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 Kids Tooth Natural Green Grape Flavor 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 Kids Tooth Natural Green Grape Flavor 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.