NDC 79814-007 Mastikis Fresh Gargle

Cetylpyridinium Chloride

NDC Product Code 79814-007

NDC 79814-007-02

Package Description: 20 POUCH in 1 PACKAGE > 10 mL in 1 POUCH (79814-007-01)

NDC Product Information

Mastikis Fresh Gargle with NDC 79814-007 is a a human over the counter drug product labeled by Mastic Korea.co.ltd. The generic name of Mastikis Fresh Gargle is cetylpyridinium chloride. The product's dosage form is mouthwash and is administered via oral form.

Labeler Name: Mastic Korea.co.ltd

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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 Fresh Gargle 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.

  • CETYLPYRIDINIUM CHLORIDE .5 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XYLITOL (UNII: VCQ006KQ1E)
  • STEVIOSIDE (UNII: 0YON5MXJ9P)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)

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.
  • 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: Mastic Korea.co.ltd
Labeler Code: 79814
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-21-2020 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.

Mastikis Fresh Gargle Product Label Images

Mastikis Fresh Gargle 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

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis, Antiplaque

Use

Helps control plaque that leads to gingivitis

Warnings

Ask a dentist before use if


- gingivitis, bleeding, or redness persists for more than 2 weeks


- you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.

Stop Use And Ask A Dentist If

  • Gingivitis, bleeding, or redness persists for more than 2 weeksyou have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a daydo not swallow children 6 years to under 12 years of age: supervise usewhen used after brushing, rinse mouth with water firstchildren under 6 years of age: do not use consult a dentist or doctor

Other Information

  • This rinse is not intended to replace brushing or flossing

Inactive Ingredients

Glycerin, Xylitol, Steviol Glycoside, Trisodium Citrate, Ascorbic Acid, L-Menthol, Green Tea Extract, Mastic Oil, Lemon Mint Flavor, Sodium Benzoate, Hydrogenated Caster Oil, Deionized Water

* Please review the disclaimer below.