Otc - Active Ingredient
Active ingredients
Hydrated Silica 13.0%
Sodium Fluoride 0.22%
Tocopheryl Acetate 0.20%
Rorobell Wawa Tooth
FDA Label NDC 81275-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rorobell for the product Rorobell Wawa Tooth (NDC 81275-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-plaque
Anti-cavity
Anti-gingivitis
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).
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
Otc - Keep Out Of Reach Of Children
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Dosage & Administration
Directions
■ Brush teeth thoroughly with an appropriate amount of toothpaste.
Other Safety Information
Other Information
■ Store at 1°C to 30°C
■ Use within 36 months from the date of manufacture
■ Do not store in high/low temperatures or direct sunlight
Otc - Questions
Questions
■ Customer Service: +82-2-515-0529
■ https://rorobell.com
Inactive Ingredient
Inactive ingredients
Sorbitol, Water, Glycerin, Hydroxyapatite, Sodium Cocoyl Glutamate, Cellulose Gum, Natural Green Grape Flavor, Stevioside, Sodium Bicarbonate, Xylitol, Sodium Hyaluronate, Allyl Isothiocyanate, Camellia Sinensis Leaf Extract, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Citrus Paradisi Fruit Extract, Calendula Officinalis Flower Extract, Pearl Powder
Package Label.Principal Display Panel
ROROBELL WAWA Kids Toothpaste Natural Green Grape Flavor
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