Otc - Active Ingredient
Active ingredient(s)
Sodium Monofluorophosphate 0.76%
Cloveden Tooth
FDA Label NDC 84516-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acuseplanet Inc for the product Cloveden Tooth (NDC 84516-010). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-cavity
Indications & Usage
Use(s)
■ Keep your teeth white and strong
■ Keep your mouth clean
■ Refresh the inside of the mouth
■ Prevent cavities and remove bad breath caused by fluorine.
■ Increases aesthetic effect
■ Prevention of gingivitis and periodontal inflammation (alveolar abscess)
■ Prevention of periodontal disease
■ Prevention of gum disease
■ Prevention of plaque deposition
■ Removal of plaque (anti-prag)
Warnings
Warnings
■ Fluorine content of this toothpaste is 1000 ppm
■ 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.
Otc - Keep Out Of Reach Of Children
■ Keep out of the reach of children under 6 years of age.
Dosage & Administration
Directions
Brushing the teeth with a suitable amount
Other Safety Information
Other Information
■ Airtight container, Store in room temperature (1~30℃)
Inactive Ingredient
Inactive ingredients
Sorbitol, Hydrated Silica, Water, Glycerin, Xylitol, Cellulose Gum, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Tetrasodium Pyrophosphate, Rubas Idaeus Fruit Extract, Menthol, Mentha Pulegium Oil, Stevioside, Tocopheryl Acetate, Mentha Piperita Oil, Citrus Limon (Lemon) Fruit Oil, Sodium Bicarbonate, Centella Asiatica Extract, Curcuma Longa Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Clove Mint Flaovr, Cooling Flavor, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Gardenia Yellow Color, Gardenia Blue Color
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