NDC 80925-201 Honest-paste Kids

Dental Type Silica

NDC Product Code 80925-201

NDC 80925-201-01

Package Description: 60 g in 1 TUBE

NDC Product Information

Honest-paste Kids with NDC 80925-201 is a a human over the counter drug product labeled by Boonco Co., Ltd. The generic name of Honest-paste Kids is dental type silica. The product's dosage form is paste and is administered via dental form.

Labeler Name: Boonco 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.

Honest-paste Kids 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.

  • SILICON DIOXIDE 8 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ROSEMARY (UNII: IJ67X351P9)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • XYLITOL (UNII: VCQ006KQ1E)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CHAMOMILE (UNII: FGL3685T2X)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)

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.
  • 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: Boonco Co., Ltd
Labeler Code: 80925
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: 10-28-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Honest-paste Kids Product Label Images

Honest-paste Kids 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 Ingredients

Dental type silica 8%

Purpose

Anticavity

Use

Helps protect against cavities

Warnings

When using this product, avoid contact with eyes and lips. If contact occurs, rinse with water.

Stop Use And Ask A Dentist If

Irritation or redness develops.

Keep Out Of Reach Of Children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Children under 1 year: ask a dentist or physicianchildren under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing)

Inactive Ingredients

Glycerin, cellulose gum, ascorbic acid, rosemary extract, scutellaria root extract, green tea extract, xylitol, calendula extract, chamomile extract, enzyme treatment stevia, l-menthol, raspberry flavor, sorbitol, purified water

* Please review the disclaimer below.