NDC 76058-005 Dr.noah Maruftoothpaste

Sodium Monofluorophosphate

NDC Product Code 76058-005

NDC 76058-005-01

Package Description: 120 g in 1 TUBE

NDC Product Information

Dr.noah Maruftoothpaste with NDC 76058-005 is a a human over the counter drug product labeled by Sungwon Pharmaceutical Co., Ltd.. The generic name of Dr.noah Maruftoothpaste is sodium monofluorophosphate. The product's dosage form is paste and is administered via oral form.

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.

Dr.noah Maruftoothpaste 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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • 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.

  • 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: Sungwon Pharmaceutical Co., Ltd.
Labeler Code: 76058
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: 09-17-2021 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.

Dr.noah Maruftoothpaste Product Label Images

Dr.noah Maruftoothpaste 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 Fluoride

Inactive Ingredient

Precipitated Calcium Carbonate

Xanthangum

Sodium Chloride

Steviol Glycoside

Xylitol

D-Sorbitol Solution

Concentrated Glycerin

Sodium Cocoyl Glutamate

Sodium Cocoyl Isethionate

Bioactive Herb Complex-C

L-Menthol

Menthol Pulegium Oil

Peppermint Oil

Spearmint Oil

Sage Extract

Aloe Extract

Green Tea Extract

Water

Purpose

■ Keeps teeth white and strong■ Keep the oral cavity clean■ Prevents tooth decay and bad breath caused by fluoride■ Removing plaque, preventing gingivitis and periodontitis■ Periodontal Disease Prevention■ Gum Disease Prevention

Keep Out Of Reach Of Children

Keep out of reach of children.

Warning

For oral use only

When using this product
■ This toothpaste has a 1,000 ppm fluoride content■ Do not use other than brushing teeth and be careful not to swallowKeep out of reach of children■ if swallowed, seek medical help or contact the poison control center immediately

Uses

For oral use only

Indication & Usage Section

Brush thoroughly ofter each meal or at least twice a day, as directed by yourdoctorordendst

Do not swallow.
Do not use if seal is broken or missing.store in a cool, dry place.

* Please review the disclaimer below.