NDC 69653-030 Finefra Clinic Tooth 100g

Sodium Monoflurophosphate

NDC Product Code 69653-030

NDC 69653-030-02

Package Description: 1 TUBE in 1 CARTON > 100 g in 1 TUBE (69653-030-01)

NDC Product Information

Finefra Clinic Tooth 100g with NDC 69653-030 is a a human over the counter drug product labeled by Jewoo Medical Co,.ltd. The generic name of Finefra Clinic Tooth 100g is sodium monoflurophosphate. The product's dosage form is paste, dentifrice and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 545626.

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.

Finefra Clinic Tooth 100g 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.

  • 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.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Jewoo Medical Co,.ltd
Labeler Code: 69653
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: 05-01-2018 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.

Finefra Clinic Tooth 100g Product Label Images

Finefra Clinic Tooth 100g 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

Active ingredients: Sodium Monofluorophosphate 0.76%

Inactive Ingredient

Inactive ingredients:D-Sorbitol Solution, Silica, Purified Water, Dentaltype Silica, Glycerin, Mika, Sodium Cocoyl Glutamate, Mentha Piperita (Peppermint) Oil, Carboxymethylcellulose Sodium, Stevioside, Charcoal Powder, Menthol, Xylitol, Allantoine Chlorohydroxy Aluminum, Aminocaproic Acid, Glycyrrhiza, Glabra (Licorice) Root Extract, Gentiana Lutea Root Extract, Sophora, Flavescens Root Extract, Lavandula Angustifolia Extract, Rhatany Tincture, Rosemary Extract, Mastic Oil, Myrrh Tincture, Salvia Officinalis (Sage) Extract, Anethole, Aloe Barbadensis Leaf Extract, Eucalyptus Oil, Chamomilla Recutita (Matricaria) Flower Extract, Chitosan, Chamaecyparis Obtusa Oil, Propolis Extract, Scutellaria Root Extract, Carvone, Silver, Hydroxyapatite


Purpose: Anticavity


Warnings:Keep out of the reach of children under 6 years of age.If you accidentally swallow more than used for brushing, Seek professional help or contact a poison control center immediately.

Keep Out Of Reach Of Children

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


Uses:Aids in the prevention of cavities, plaque, and gingivitis.


Directions:Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Do not swallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

* Please review the disclaimer below.