NDC 73242-0100 Doctrust 2x Tooth

Sodium Fluoride

NDC Product Code 73242-0100

NDC CODE: 73242-0100

Proprietary Name: Doctrust 2x Tooth What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Fluoride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 73242 - Dong Il Pharms Co.,ltd

NDC 73242-0100-1

Package Description: 100 g in 1 TUBE

NDC Product Information

Doctrust 2x Tooth with NDC 73242-0100 is a a human over the counter drug product labeled by Dong Il Pharms Co.,ltd. The generic name of Doctrust 2x Tooth is sodium fluoride. The product's dosage form is paste and is administered via dental form.

Labeler Name: Dong Il Pharms Co.,ltd

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Doctrust 2x Tooth Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM FLUORIDE .22 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.
  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dong Il Pharms Co.,ltd
Labeler Code: 73242
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-14-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Doctrust 2x Tooth Product Label Images

Doctrust 2x Tooth Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Sodium Flouride

Otc - Purpose

Keep your teeth white and strong.

Keep your mouth clean.

Refresh the inside of the mouth.

Prevents tooth decay and bad breath by fluoride

Increase esthetic effect.

Removal of plaque (anti-plaque)

Prevention of gingivitis and periodontitis

Periodontal Disease Prevention

Prevention of gum disease

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Brushing the teeth with a suitable amount

Warnings

(1) Contains 1000ppm of 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 itunder the supervision of a guardian to avoid sucking or swallowing.

(5) Consult a physician or dentist immediately if a child under 6 years old

hasswallowed large quantities.

(6) Keep out of the reach of children under 6 years of age.

Inactive Ingredient

Tocopherol Acetate, Silicon Dioxide, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Chitosan, Propolis Extract, Glycyrrhiza Extract Powder, Ascorbic Acid, Green Tea Extract, Curcuma xanthorrhiza Extract, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, Sodium Bicarbonate, L-Menthol, Peppermint Oil, Water

Dosage & Administration

For dental use only

* Please review the disclaimer below.