NDC 70477-080 Mongdies Raspberry Baby Tooth

Silicon Dioxide

NDC Product Code 70477-080

NDC 70477-080-02

Package Description: 1 TUBE in 1 CARTON > 100 g in 1 TUBE (70477-080-01)

NDC Product Information

Mongdies Raspberry Baby Tooth with NDC 70477-080 is a a human over the counter drug product labeled by 360perspective Inc.. The generic name of Mongdies Raspberry Baby Tooth is silicon dioxide. The product's dosage form is paste, dentifrice and is administered via topical form.

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 Raspberry Baby 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.

  • SORBITOL (UNII: 506T60A25R)
  • XYLITOL (UNII: VCQ006KQ1E)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)

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
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: 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 Raspberry Baby Tooth Product Label Images

Mongdies Raspberry Baby 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

Silicon Dioxide 15%

Purpose

Anti-plaque

Warnings

1. For babies under 3 years old. 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 the mouth clean and refresh the inside of the mouth. It prevents the cavity and removes plaque.

Directions

Apply a rice sized amount and gently brush baby’s teeth.

Inactive Ingredients

D-Sorbitol Solution, Carboxymethylcellulose sodium, Xylitol, Steviol Glucoside, Sodium methyl cocoyl Taurate, Chitosan, Ascorbic Acid, Pyridoxine Hydrochloride, Rosemary Extract, Chamomile Extract(2), Strawberry Extract, Calendula Extract, Eucalyptus Oil, Orange Oil, Raspberry Flavor HF-AF11842, Purified Water

* Please review the disclaimer below.