NDC 76670-0003 Doctrust K

Sodium Flouride

NDC Product Code 76670-0003

NDC 76670-0003-1

Package Description: 60 mL in 1 TUBE

NDC Product Information

Doctrust K with NDC 76670-0003 is a a human over the counter drug product labeled by Dr.s Medi Co.,ltd.. The generic name of Doctrust K is sodium flouride. The product's dosage form is liquid and is administered via dental form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 K 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.


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.

  • WATER (UNII: 059QF0KO0R)

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.

Product Labeler Information

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

Labeler Name: Dr.s Medi Co.,ltd.
Labeler Code: 76670
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: 08-22-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Doctrust K Product Label Images

Doctrust K 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 fluoride

Inactive Ingredient

Hydroxyapatite, Curcuma extract, Xylitol, Centella asiatica extract, Houttuynia cordata extract, Green tea extract, Salvia officinalis extract, Eucalyptus globulus extract. Flavoring agent, Sodium cocoyl isethionate, Sodium cocoyl glutamate, Carboxymethylcellulose sodium, D-sorbitol solution, Enzymatically modified stevia, Purified water

Otc - Purpose

Helps protect against cavities

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Indications & Usage

- Adults and children 2 years or 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 yearsUse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).- Children under 2 years of age:Ask a dentist or physician.

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Dental use only

* Please review the disclaimer below.