NDC 0869-0299 Antiseptic
Cetylpyridinium Chloride Rinse Oral

Product Information

Product Code0869-0299
Proprietary Name 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.
Antiseptic
Non-Proprietary Name 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.
Cetylpyridinium Chloride
Product Type 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.
Human Otc Drug
Dosage FormRinse - A liquid used to cleanse by flushing.
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.
Vi-jon, Llc
Labeler Code0869
FDA Application Number 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.
part356
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-05-1995
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 0869-0299-86

Package Description: 1 L in 1 BOTTLE, PLASTIC

Product Details

Antiseptic is a human over the counter drug product labeled by Vi-jon, Llc. The generic name of Antiseptic is cetylpyridinium chloride. The product's dosage form is rinse and is administered via oral form.


What are Antiseptic Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)


* Please review the disclaimer below.

Antiseptic Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Claim



swan

Alcohol-Free

ANTISEPTIC RINSE

ANTIGINGIVITIS/

ANTIPLAQUE MOUTHRINSE

For better oral hygiene

and fresher breath


Active Ingrediet



Cetylpyridinium chloride 0.07%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



for this product


Stop Use And Ask A Dentist If



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

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

if more than used for rinsing is accidentally swallowed, tet 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 day
  • do not swallow
  • children 6 yeard to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other Information



 •this rinse is not intended to replace brushing or flossing


Inactive Ingredients



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


Disclaimer



This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurence.

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint


Adverse Reactions



Distributed by: Vi-Jon, Inc., St. Louis, MO 63114

299.005/299AK


Principal Display Panel



NDC 0869-0229-86

Sealed with printed neckband for your protection

Swan

Alcohol-Free

ANTISEPTIC RINSE

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

ZESTY MINE

  • Kills germs
  • Helps prevent plaque
  • Helps prevent gingivitis
  • Helps keep teeth feeling clean
  • Freshens breath
  • No burn of  alcohol
  • Compare to Crest Pro-health Multi Protection Alcohol Free Rinse Refreshing Clean Mint

    1 LITER (33.8 FL OZ)


* Please review the disclaimer below.