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| Product NDC Code | 72346-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Medi i tooth |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 2379031 | ||||
| Application Number | part355 | ||||
| Labeler Name | MEDIF CO.,LTD | ||||
| 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 Sodium Monofluorophosphate 0.38%
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 ■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician ■ Children 2 to 6 years: Use only a pea-sized amount and supervise child’s brushing and rinsing (to minimize swallowing) ■ Children under 2 years: Ask a dentist or physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water, Sorbitol, Silica, Glycerin, Strawberry flavor, Xanthan gum, Sodium Cocoyl Glutamate, Xylitol, Stevioside, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Aloe Barbadensis Leaf Extract, Matricaria 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.Uses 1) Keep your teeth white and strong. 2) Keep your mouth clean. 3) Refresh the inside of the mouth. 4) To prevent tooth decay and remove bad breath. 5) Increase esthetic effect. 6) Removal of plaque(anti-plaque).
Purpose
Information about the drug product’s indications for use.PURPOSE Anticarries
Spl product data elements
Usually a list of ingredients in a drug product.Medi i Tooth Sodium Monofluorophosphate Sodium Monofluorophosphate FLUORIDE ION Water Sorbitol SILICON DIOXIDE Glycerin
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 the reach of children under 6 years age.
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 1) This toothpaste contains 500ppm fluoride. 2) Do not swallow and rinse mouth thoroughly after use. 3) If you experience any problems with your gums or mouth during use discontinue use and consult your doctor. 4) 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. 5) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. 6) Keep out of the reach of children under 6 years 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