NDC 73242-0040 Kosette Salt Tooth

Sodium Monofluorophosphate

NDC Product Code 73242-0040

NDC 73242-0040-1

Package Description: 100 g in 1 TUBE

NDC Product Information

Kosette Salt Tooth with NDC 73242-0040 is a a human over the counter drug product labeled by Dong Il Pharms Co.,ltd. The generic name of Kosette Salt Tooth is sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Dong Il Pharms Co.,ltd

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.

Kosette Salt 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 MONOFLUOROPHOSPHATE .76 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.

  • XYLITOL (UNII: VCQ006KQ1E)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SORBITOL (UNII: 506T60A25R)

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: 05-01-2020 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 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.

Kosette Salt Tooth Product Label Images

Kosette Salt 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 MONOFLUOROPHOSPHATE

Otc - Purpose

ANTI-CAVITY

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician

Warnings

Storage method1. Keep it at room temperature in a classified container. 2. Cover and store at room temperature. 3. Store in a not moisture and cool place. 4. Air may come out during use of this product, but there is no problem with its weight.Usage Precautions1. Be careful not to swallow. Rinse mouth thoroughly after use2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.5. Keep out of the reach of children under 6 years of age.

Inactive Ingredient

D-Sorbitol Solution, WATER, SILICON DIOXIDE, CONCENTRATED GLYCERIN, SODIUM COCOYL GLUTAMATE, POLYETHYLENE GLYCOL 1500, CARBOXYMETHYLCELLULOSE SODIUM, PEPPERMINT OIL, ACTIVE CARBON, L-MENTHOL, CITRUS PARADISI (GRAPEFRUIT) SEED EXTRACT, XYLITOL, SODIUM CHLORIDE, ENZYMATICALLY MODIFIED STEVIA, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALOE EXTRACT, SAGE EXTRACT

Dosage & Administration

For dental use only

* Please review the disclaimer below.