NDC 73527-0002 Onetooth Clinic Tooth

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

NDC Product Code 73527-0002

NDC CODE: 73527-0002

Proprietary Name: Onetooth Clinic 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: Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate 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.

NDC Code Structure

  • 73527 - Cone Medical Co., Ltd.

NDC 73527-0002-1

Package Description: 20 g in 1 TUBE

NDC Product Information

Onetooth Clinic Tooth with NDC 73527-0002 is a a human over the counter drug product labeled by Cone Medical Co., Ltd.. The generic name of Onetooth Clinic Tooth is silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate. The product's dosage form is paste and is administered via dental form.

Labeler Name: Cone Medical 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.

Onetooth Clinic 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 PYROPHOSPHATE .5 g/100g
  • SILICON DIOXIDE 14 g/100g
  • ALPHA-TOCOPHEROL ACETATE .1 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)
  • 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.

Product Labeler Information

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

Labeler Name: Cone Medical Co., Ltd.
Labeler Code: 73527
Marketing Category: UNAPPROVED DRUG OTHER - 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: 03-01-2021 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.

Onetooth Clinic Tooth Product Label Images

Onetooth Clinic 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

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

Otc - Purpose

For dental healthFor dental care

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Brushing the teeth with a suitable amount

Warnings

  • Do not swallow and rinse mouth thoroughly after use If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.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. Consult a physician or dentist immediately if a child under 6 years old hasswallowed large quantities. Keep out of the reach of children under 6 years of age.

Inactive Ingredient

D-Sorbitol Solution, Concentrated Glycerin, Carboxymethylcellulose Sodium, Hydroxyapatite, Medicinal Carbon, Chitosan, Titanium Oxide and Mica, Zeolite, Xylitol, Steviol Glycoside, Papain, Grapefruit Seed Extract, L-Menthol, Mentha Oil, Propolis Extract, Chamomile Extract, Rosemary Extract, Sage Extract, Aloe Extract, Glycyrrhiza Extract, Lavender Oil, Horsetail Extract, Sodium Cocoyl Glutamate, Lauroyl Amidopropyl Dimethyl Glycine Solution, Deionized Water

Dosage & Administration

For dental use only

* Please review the disclaimer below.