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Product NDC Code | 76670-0010 | ||||
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Drug Name | Doctrust doublex tooth |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 245598 | ||||
Application Number | M021 | ||||
Labeler Name | DOCSMEDI OralBiome Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Sodium fluoride 0.22% (Total Fluoride Content 1,000 ppm Approx.)
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 doctor. ■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. ■ Children under 2 years: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Sodium Tocopheryl Acetate, Silicon Dioxide, Chitosan, Propolis Extract, D-sorbitol Solution, Sodium Carboxymethyl Cellulose, Licorice Extract, Ascorbic Acid, Camellia Sinensis Extract, Curcumin Extract, Xylitol, Enzymatically Modified Stevia, Sodium Cocoylglutamate, Sodium Bicarbonate, L-menthol, Peppermint Oil, Purified 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 ■ Helps protect against cavities
Purpose
Information about the drug product’s indications for use.PURPOSE Anticavity Toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.DOCTRUST DOUBLEX Tooth Sodium fluoride Sodium fluoride FLUORIDE ION Silicon Dioxide PROPOLIS WAX
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 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 ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions https://docsmedi.kr Tel: 82-031-922-2240, Fax: 82-43-883-2844
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 swallow and rinse mouth thoroughly after use ■ For children under 6 years of age, use small amounts of toothpaste. 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