Otc - Active Ingredient
Active ingredients
Silica 7.0%
Hydrogen Peroxide (35%) 2.14%
Tocopheryl Acetate 0.2%
Rorobell Wawa Whitening Tooth Paste, Dentifrice
FDA Label NDC 81275-013
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 Whitening Tooth (NDC 81275-013). 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
Whitening
Anti-gingivitis
Indications & Usage
Uses
■ Helps whiten teeth.
■ Helps prevent cavities.
■ Helps eliminate bad breath.
■ Helps strengthen teeth.
■ Helps keep the oral cavity clean.
■ Helps freshen the oral cavity.
■ Helps improve the appearance of teeth.
■ Helps prevent gingivitis and periodontitis (pyorrhea).
■ Helps prevent periodontal disease.
■ Helps prevent gum disease.
■ Helps remove dental plaque (anti-plaque).
Warnings
Warnings
Precautions for Use
■ Do not use this product for any purpose other than brushing teeth.
■ If a large amount of this product is accidentally swallowed, follow the instructions of a pharmacist, dentist, or physician.
Storage Instructions
■ Keep out of reach of children. Children should use this product only under adult supervision.
■ Avoid direct sunlight. Keep the cap tightly closed and store at room temperature.
Whitening Toothpaste Warnings
■ Avoid using this product if you have mouth sores, severe cavities, or severe periodontal disease, as it may cause significant irritation.
■ If your gums become red or sore after use, discontinue use, as this whitening toothpaste may not be suitable for you.
■ This product contains hydrogen peroxide as its whitening active ingredient. The tube may swell due to the release of oxygen generated by hydrogen peroxide. This is a natural phenomenon and does not affect the quality of the product. You may also hear a sound as carbon dioxide escapes from the tube during use.
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
Water, Glycerin, Sodium Cocoyl Glutamate, Sodium metaphosphate, Xylitol, Grapefruit Flavor, Cellulose Gum, Glucosyl Stevioside, Xanthan gum, Menthol, Grapefruit Flavor20, Citric Acid, Alanine, Mentha Pulegium Oil, Citrus Paradisi Peel Oil, Disodium Pyrophosphate, Disodium EDTA, Allantoin, Sodium Hyaluronate, Persea Gratissima Oil, Sodium Ascorbate, Hydroxyapatite, Allyl Isothiocyanate, Camellia Sinensis Leaf Extract, Fragaria Vesca Fruit Extract, Rosmarinus Officinalis Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi Fruit Extract, Calendula Officinalis Flower Extract, Propolis Wax, Cocos Nucifera Oil, Mentha Piperita Oil, Papain, Pearl Powder
Package Label.Principal Display Panel
ROROBELL WAWA Whitening Toothpaste
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