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Product NDC Code | 82662-060 | ||||
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Drug Name | Toosty original cool mint toothpaste |
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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 | Headquarter Co., Ltd | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS 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 ■ Use adequate amount of toothpaste on a toothbrush to brush your teeth and rinse off with water.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Precipitated Calcium Carbonate, Dicalcium Phosphate Digydrated, Aluminium Chlorohydroxy Allantoinate, Sodium Pyrophosphate, Sodium Monofluorophosphate, D-Sorbitol Solution, Concentrated Glycerin, Sodium Carboxymethylcellulose, Silicon Dioxide, Xylitol, Stevioside, Lufa Extract, L-Menthol, Menthol Pulegium Oil, Peppermint Oil, Jasmine Mint Flavor, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Water
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.Uses ■ Premium toothpaste for freshen bad breath and prevent dental plaque ■ It contains tartar-inhibiting ingredient "TSPP (Sodium Pyrophosphate)" to prevent tartar from accumulating (KFDA certified ingredient) ■ It contains natural surfactant derived from coconut, which makes your mouth less dry and keeps your mouth moist ■ 14 Hazardous Ingredients-Free (paraben, synthetic preservative, microbeads, synthetic surfactant, mineral oil, triclosan, human harmful scent, PEG/PG, saccharin, polypropylene, MIT/CMIT, polyethylene, artificial pigment) ■ Vegan toothpaste officially certified by the Korea Institute of Vegan Certification ■ Keep your teeth white and strong ■ Keep the mouth clean ■ Refresh the mouth ■ Fluorine prevents tooth decay and removes bad breath ■ increase the aesthetic effect ■ Prevention of gingivitis (diastolic fistula), prevention of periodontal disease, prevention of gum disease, prevention of tartar deposition, and removal of plaque (anti-plaque)
Purpose
Information about the drug product’s indications for use.PURPOSE Antiplaque
Spl product data elements
Usually a list of ingredients in a drug product.Toosty Original Cool Mint Toothpaste Sodium Monofluorophosphate Sodium Monofluorophosphate FLUORIDE ION Calcium Carbonate ANHYDROUS DIBASIC CALCIUM PHOSPHATE ALCLOXA
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton
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 REACH OF CHILDREN Keep out of reach of children under the age of 6
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ Store in room temperature (1-30℃ or 33.8-86℉)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ■ www.toosty.kr
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 ■ The fluoride content of this toothpaste is 1000 PPM ■ Be careful not to swallow, and rinse the mouth thoroughly after use ■ If the use of this toothpaste causes abnormalities, such as damage to the gums or mouth, stop using it and consult with a doctor or dentist ■ When used by a child under the age of 6, a small amount of toothpaste the size of a pea at a time shall be used under the guidance of the guardian to prevent sucking or swallowing ■ If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately ■ Keep out of reach of children under the age of 6
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