NDC 70477-060 Mongdies Spearmint Adult Tooth

Sodium Monofluorophosphate

NDC Product Code 70477-060

NDC 70477-060-02

Package Description: 1 TUBE in 1 CARTON > 100 g in 1 TUBE (70477-060-01)

NDC Product Information

Mongdies Spearmint Adult Tooth with NDC 70477-060 is a a human over the counter drug product labeled by 360perspective Inc.. The generic name of Mongdies Spearmint Adult Tooth is sodium monofluorophosphate. 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: 1193319.

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.

Mongdies Spearmint Adult 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)

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: 360perspective Inc.
Labeler Code: 70477
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: 09-01-2021 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.

Mongdies Spearmint Adult Tooth Product Label Images

Mongdies Spearmint Adult 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 0.6%

Purpose

Anti-plaque

Warnings

1. For adults only. 2. Be careful not to swallow, and rinse mouth thoroughly after use. 3. If any abnormality occurs such as gums or mouth injuries with this toothpaste, discontinue use and consult a doctor or dentist.4. If a child under the age of 7 swallows a large amount, consult a doctor or dentist immediately. 5. Keep out of the reach of children under 7 years of age.

Keep Out Of Reach Of Children

Keep out of the reach of children under 7 years of age.

Uses

It Keeps teeth white and firm. It Keeps the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes the bad breath. It Increases the aesthetic effect. Removing plaque (anti-plaque), Prevention of gingivitis, periodontitis (gingivitis), periodontal disease, gum disease.

Directions

Apply a proper amount of toothpaste to the toothbrush and brush your teeth.

Inactive Ingredients

Silicon Dioxide, Sodium pyrophosphate, Pyridoxine hydrochloride, L-Menthol, glycerin, Camellia sinensis leaf extract, Rosemary extract, Mastic, Cellulose gum, Sodium methyl cocoyl taurate, Sorbitol solution, PARFUM, Sodium Chloride, Xylitol, Purified water, Calendula extract, Chamomile extract, Peppermint oil, Propolis extract, Scutellaria Baicalensis root extract, Enzyme treatment Stevia

* Please review the disclaimer below.