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| Product NDC Code | 84516-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Cloveden sensitive care tooth |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 245598 | ||||
| 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 Fluoride 0.221%
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 ■ Apply an appropriate amount to a toothbrush twice a day (morning and evening) and brush your teeth by brushing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sorbitol, Hydrated Silica, Water, Hydroxyapatite, Potassium Nitrate, Glycerin, Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Methyl Cocoyl Taurate, Xylitol, Menthol, Stevioside, Mentha Pulegium Oil, Mentha Piperita Oil, Cooling Flavor, Mint Flavor, Sodium Chloride, Clove Mint Flaovr, Tocopheryl Acetate, Eugenia Caryophyllus (Clove) Flower Oil, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Calendula Officinalis Flower Extract
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) ■ Protection of sensitive teeth ■ Removal of plaque (anti-prag) ■ Prevention of Tooth decay by Fluoride ■ Keep your teeth white and strong ■ Keep your mouth clean ■ Refresh the inside of the mouth ■ Removes bad breath ■ Increases aesthetic effect
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 Sensitive Care Tooth Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION TRIBASIC CALCIUM PHOSPHATE WATER SORBITOL
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.If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.
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 ■ Do not do the following while using this products Do not use it except for brushing teeth. ■ Other precautions to be taken when using non-medical products 1) The fluoride content of this toothpaste is 1,000 ppm (the total content must be 1,000 ppm or less). 2) If used by children under the age of six, use a small amount of toothpaste about the size of peas per use, and have it used under the guidance of a guardian to prevent washing or swallowing. 3) If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately. ■ Storage precautions 1) Store out of reach of children under the age of six. 2) Remove the non-drug from the original container and store it in another container, which can cause accidents or poor product quality due to misuse, so put it in the original container and keep it closed tightly.
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