Otc - Active Ingredient
Active ingredients
Hydrated Silica 18.5%
Potassium Nitrate 5.0%
Sodium Fluoride 0.3152%
The following Structured Product Label (SPL) was submitted to the FDA by Rorobell for the product Rorobell Wawa Sensitive Teeth Tooth (NDC 81275-014). 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.
Active ingredients
Hydrated Silica 18.5%
Potassium Nitrate 5.0%
Sodium Fluoride 0.3152%
Purpose
Anti-plaque
Protection of sensitive teeth
Anti-cavity
Uses
■ Helps keep teeth white and strong.
■ Helps keep the oral cavity clean.
■ Helps freshen the oral cavity.
■ Helps eliminate bad breath.
■ Helps improve the appearance of teeth.
■ Helps prevent and relieve tooth sensitivity.
■ Helps remove dental plaque (anti-plaque).
■ Helps prevent cavities with fluoride.
Warnings
Do not use this product
■ Do not use this product if you are hypersensitive or allergic to any of its ingredients.
When using this product
■ Use this product only for brushing teeth.
Stop use and ask a physician, dentist, or pharmacist if
Bring the product information with you whenever possible when seeking medical advice.
■ Irritation develops after using this product.
■ Swelling of the mouth or face occurs. This may be a sign of a very rare allergic reaction.
Other warnings
■ This toothpaste contains 1,426 ppm fluoride.
■ Because this toothpaste contains potassium nitrate, consult a physician or dentist before use in children under 12 years of age.
■ Do not swallow this toothpaste. Rinse your mouth thoroughly after use.
■ Children under 6 years of age should use only a pea-sized amount of toothpaste under adult supervision to prevent sucking or swallowing the toothpaste.
■ If a child under 6 years of age swallows a large amount of this toothpaste, consult a physician or dentist immediately.
■ Tooth sensitivity may indicate an underlying condition that requires prompt treatment. If symptoms persist or worsen, consult a dentist.
■ Because this toothpaste contains more than 1,000 ppm fluoride, consult a physician or dentist before use in children under 6 years of age.
■ As with other oral care products, discontinue use if irritation develops.
Storage
■ Keep out of reach of children under 6 years of age.
■ Store this product in its original container with the cap tightly closed. Do not transfer it to another container, as doing so may result in accidental misuse or reduce the quality of the product.
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Directions
■ Brush teeth twice daily by applying an appropriate amount of toothpaste to a toothbrush.
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
Questions
■ Customer Service: +82-2-515-0529
■ https://rorobell.com
Inactive ingredients
Sorbitol, Water, Glycerin, Hydroxyapatite, Sodium Cocoyl Glutamate, Cellulose Gum, Xylitol, Glucosyl Stevioside, Mint Flavor, Mentha Spicata Herb Oil, Menthol, Mint Flavor46, Sodium Bicarbonate, Mentha Piperita Oil, Cooling Agent, Allantoin, Sodium Hyaluronate, Persea Gratissima Oil, Sodium Ascorbate, Tocopheryl Acetate, Allyl Isothiocyanate, Camellia Sinensis Leaf 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, Mentha Pulegium Oil, Cocos Nucifera Oil, Pearl Powder
ROROBELL WAWA Sensitive Teeth Toothpaste
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