NDC 22431-145 Antimicrobial Liquid Citrus

Benzalkonium Chloride

NDC Product Code 22431-145

NDC 22431-145-01

Package Description: 2000 mL in 1 BOTTLE

NDC 22431-145-02

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Antimicrobial Liquid Citrus with NDC 22431-145 is a a human over the counter drug product labeled by Blue Cross Laboratories. The generic name of Antimicrobial Liquid Citrus is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Blue Cross Laboratories

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Antimicrobial Liquid Citrus 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.

  • BENZALKONIUM CHLORIDE .3 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 LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Blue Cross Laboratories
Labeler Code: 22431
FDA Application Number: part333A 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: 06-21-2019 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: 12-31-2020 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.

Antimicrobial Liquid Citrus Product Label Images

Antimicrobial Liquid Citrus 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

Otc - Active Ingredient

Active Ingredient PurposeBenzalkonium Chloride 0.3% Antimicrobial

Otc - Purpose

Uses Antimicrobial hand soap

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental Ingestion, seek medical attention or contact a poison control center immediately.

Indications & Usage

  • When using this product do not use in or near eyes

Warnings

WarningsFor external use only

Dosage & Administration

  • Directions wet handsdispense a small amount of soap into the palm of the handWork up a lather, adding water as neededRinse and dry thoroughly

Inactive Ingredient

Inactive ingredients: Dodecylbenzenesulfonic Acid, Ninol 40-CO, Caustic Soda 50%, Sodium Laureth Sulfate, Fragrance, FD&C Red#40, FD&C Yellow #5

* Please review the disclaimer below.