NDC 0135-0650 Parodontax Active Gum Health Clear Mint

Cetylpyridinium Chloride

NDC Product Code 0135-0650

NDC CODE: 0135-0650

Proprietary Name: Parodontax Active Gum Health Clear Mint What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cetylpyridinium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0135 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0135-0650-01

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Parodontax Active Gum Health Clear Mint with NDC 0135-0650 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Parodontax Active Gum Health Clear Mint is cetylpyridinium chloride. The product's dosage form is mouthwash and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1100924.

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.

Parodontax Active Gum Health Clear Mint 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • 2,3'-IMINODI-BENZOIC ACID (UNII: H1C37ZB0P3)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)

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.

Product Labeler Information

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

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
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: 01-03-2022 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.

Parodontax Active Gum Health Clear Mint 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 0.07% w/w

Purpose

Antigingivitis, Antiplaque

Uses

  • Helps prevent and reduce plaque that leads to •gingivitis, an early form of gum disease •bleeding gums

Stop Use And Ask A Dentist If

  • •irritation occurs •gingivitis, bleeding, or redness persists for more than 2 weeks •you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or 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 of age and older: measure twice up to 10 milliliters mark inside of cap. Vigorously swish 20 milliliters of the rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. Do not rinse with water. Do not drink from bottle. •children 6 years to under 12 years of age: supervisor use •children under 6 years of age: do not use

Other Information

  • •this rinse is not intended to replace brushing or flossing •may cause staining •Do not store above 25°C or 77°F

Inactive Ingredients (Mint)

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Inactive Ingredients (Clear Mint)

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid

Additional Information

*Kills plaque bacteria associated with gingivitis and odor-causing bacteria in a laboratory testDo not use if the printed seal on the capis broken or missing.ALWAYS FOLLOW THE LABELDistributed by: GSK Consumer HealthcareWarren, NJ 07059Trademarks owned by or licensed by GSK.©2021 GSK or licensor.1-855-328-5202

* Please review the disclaimer below.