NDC 33992-0320 Assured Oral Health Fresh Mint

Cetylpyridinium Chloride

NDC Product Code 33992-0320

NDC 33992-0320-7

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Assured Oral Health Fresh Mint with NDC 33992-0320 is a a human over the counter drug product labeled by Greenbrier International, Inc.. The generic name of Assured Oral Health Fresh Mint is cetylpyridinium chloride. The product's dosage form is rinse and is administered via oral form.

Labeler Name: Greenbrier International, Inc.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

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.

Assured Oral Health Fresh 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.

  • CETYLPYRIDINIUM CHLORIDE .07 g/100mL

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.

  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SACCHARIN (UNII: FST467XS7D)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Greenbrier International, Inc.
Labeler Code: 33992
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: 10-21-2019 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.

Assured Oral Health Fresh 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

Other

For better oral hygiene and fresher breathDrug Facts

This rinse may cause temporary staining to the surface of the teeth. This is not harmful, and adequate brushing may prevent its occurrence.*This product is not manufactured or distributed by Proctor & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint.DISTRIBUTED BY: GREENBRIER INTERNATIONAL INC.500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Otc - Active Ingredient

Active ingredient
Cetylpyridinium chloride 0.07%

Otc - Purpose

PurposeAntigingivitis, Antiplaque

Indications & Usage

Usehelps control plaque that leads to gingivitis

Warnings

Warnings

Otc - Stop Use

  • Stop use and ask a dentist ifgingivitis, 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 symptoms of periodontitis, a serious form of gum disease.

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

  • Directionsadults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a daydo not swallowchildren 6 to under 12 years of age: supervise usewhen used after brushing. rinse mouth with water firstchildren under 6 years of age: do not use

Other Safety Information

  • Other informationthis rinse is not intended to replace brushing or flossing

Inactive Ingredient

Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

* Please review the disclaimer below.