Otc - Active Ingredient
Active ingredients
Hydrated Silica 19.0%
Sodium Fluoride 0.32%
Tocopheryl Acetate 0.05%
Rorobell Wawa Gum Care Tooth Paste, Dentifrice
FDA Label NDC 81275-011
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 Gum Care Tooth (NDC 81275-011). 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.
■ 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).
Warnings
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.
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, Xylitol, Menthol, Thyme Flavor, Mentha Piperita Oil, Sodium Saccharin, Sodium Bicarbonate, Erythritol, Pistacia Lentiscus Gum Oil, Sodium Copper Chlorophyllin, Aloe Barbadensis Leaf Extract, Glycyrrhiza Uralensis Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi Fruit Extract, Taraxacum Officinale Extract, Allyl Isothiocyanate
Package Label.Principal Display Panel
ROROBELL WAWA Gum Care Toothpaste
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