NDC 53942-299 Antispetic

Cetylpyridinium Chloride

NDC Product Code 53942-299

NDC 53942-299-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Antispetic with NDC 53942-299 is a a human over the counter drug product labeled by Demoulas Super Markets. The generic name of Antispetic is cetylpyridinium chloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Demoulas Super Markets

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Antispetic 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 .7 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)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Demoulas Super Markets
Labeler Code: 53942
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: 02-21-2012 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.

Antispetic Product Label Images

Antispetic 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

Claims

For better oral hygiene and fresher breath.

Active Ingredient

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, gleeding 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 or smptoms 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 swallowchildren 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

Other Information

  • This rinse is not intended to replace brushing or flossing

Inactive Ingredients

Water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, methylparaben, sucralose, propylparaben, blue1

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Rinse

Adverse Reaction

DISTRIBUTED BYDEMOULAS SUPER MARKETS, INC.875 EAST STREETTEWKSBURY, MA 01876

* Please review the disclaimer below.