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| Product NDC Code | 84516-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Cloveden tooth |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | M021 | ||||
| Labeler Name | Acuseplanet Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient(s) Sodium Monofluorophosphate 0.76%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Brushing the teeth with a suitable amount
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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)
Purpose
Information about the drug product’s indications for use.Purpose Anti-cavity
Spl product data elements
Usually a list of ingredients in a drug product.Cloveden Tooth Sodium Monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION GLYCERIN SORBITOL WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Carton Image
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.■ Keep out of the reach of children under 6 years of age.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ Airtight container, Store in room temperature (1~30℃)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API