NDC 79814-009 Mastikis Mastic Gumcare

Silicon Dioxide, Aminocaproic Acid

NDC Product Code 79814-009

NDC 79814-009-02

Package Description: 1 TUBE in 1 CARTON > 120 g in 1 TUBE (79814-009-01)

NDC Product Information

Mastikis Mastic Gumcare with NDC 79814-009 is a a human over the counter drug product labeled by Mastic Korea.co.ltd. The generic name of Mastikis Mastic Gumcare is silicon dioxide, aminocaproic acid. The product's dosage form is paste, dentifrice and is administered via dental 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.

Mastikis Mastic Gumcare 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • XYLITOL (UNII: VCQ006KQ1E)
  • STEVIOSIDE (UNII: 0YON5MXJ9P)
  • SODIUM ASCORBATE (UNII: S033EH8359)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CITRUS PARADISI SEED (UNII: 12F08874Y7)
  • LICORICE (UNII: 61ZBX54883)
  • SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • WATER (UNII: 059QF0KO0R)

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.

Product Labeler Information

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

Labeler Name: Mastic Korea.co.ltd
Labeler Code: 79814
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: 08-10-2021 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.

Mastikis Mastic Gumcare Product Label Images

Mastikis Mastic Gumcare 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

Otc - Active Ingredient

Silicon Dioxide 16%Aminocaproic Acid 0.1%

Inactive Ingredient

D-Sorbitol Solution, Glycerin, Carboxymethylcellulose Sodium, Corn Starch, Xylitol, Steviol Glycoside, Sodium Ascorbate, Hydroxyapatite, Sodium Bicarbonate, L-Menthol, Mastic Oil, Mentha Oil, Olive Oil, Eucalyptus Oil, Grapefruit Seed Extract, Glycyrrhiza Extract, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Deionized Water

Otc - Keep Out Of Reach Of Children

Keep out of Reach of Children.

Otc - Purpose

Anti-cavityAnti-gingivitis

Warnings

Ask a dentist before use if you have - bleeding or redness lasting more than 2 weeks pain, swelling, pus, losse teeth, or more spacing between teeth- These may be signs of periodontitis, a serious form of gum disease

Indications & Usage

- Healthier teeth and gums, and better oral hygiene.- Anti-caries, anti-plaque, anti-gingivitis- Prevents periodontal and gum disease

Dosage & Administration

Brush teeth with a pea-sized amount

* Please review the disclaimer below.