Active Ingredient
Sodium Monofluorophosphate 0.72%
Rorobell Wawa Tooth Paste, Dentifrice
FDA Label NDC 81275-010
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 81275-010). 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 active ingredient, inactive ingredients, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Calcium Carbonate, Dicalcium Phosphate Dihydrate, Aluminium Chlorohydrate, Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Thymus quinquecostatus Flavor, Menthol, Xylitol, Erythritol, Mentha Piperita (Peppermint) Oil, Hydroxyapatite, Sodium Copper Chlorophyllin, Allyl Isothiocyanate, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Grandis (Grapefruit) Fruit Extract, Taraxacum Officinale (Dandelion) Rhizome, Pistacia Lentiscus (Mastic) Gum
Purpose
Caries prevention
Warnings
■ Contains 950ppm of fluoride.
■ Do not swallow and rinse mouth thoroughly after use
■ If you experience any problems with your gums or mouth during use,
discontinue use and consult your doctor.
■ For children under 6 years of age, use small amounts of toothpaste. And use it
under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has
swallowed large quantities.
■ Keep out of the reach of children under 6 years of age.
Keep Out Of Reach Of Children
Keep out of the reach of children under 6 years of age.
Uses
■ Keep your teeth white and strong.
■ Keep your mouth clean.
■ Refresh the inside of the mouth.
■ Prevents tooth decay caused by fluoride and removes bad breath.
■ Increases aesthetic effect.
■ Prevention of gingivitis and periodontitis (alveolar fistula)
■ Prevention of periodontal disease
■ Prevention of gum disease
■ Prevention of plaque deposition, removal of plaque (anti-prag)
Directions
■ Brushing the teeth with a suitable amount
Other Information
Airtight container, Store in normal temperature (1~30℃)
Questions
02-515-0529
www.rorobell.com
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