NDC 72346-100 Medi I Tooth

Sodium Monofluorophosphate

NDC Product Code 72346-100

NDC 72346-100-02

Package Description: 1 TUBE in 1 CARTON > 70 g in 1 TUBE (72346-100-01)

NDC Product Information

Medi I Tooth with NDC 72346-100 is a a human over the counter drug product labeled by Medif Co.,ltd. The generic name of Medi I Tooth is sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2379031.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Medi I 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.


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)
  • SORBITOL (UNII: 506T60A25R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Medif Co.,ltd
Labeler Code: 72346
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: 08-01-2020 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: 12-31-2021 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.

Medi I Tooth Product Label Images

Medi I 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

Active Ingredient

Sodium Monofluorophosphate 0.38%

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

Purpose

Anticarries

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.

Keep Out Of Reach Of Children

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

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).

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

* Please review the disclaimer below.