NDC 33992-8991 Benzalkonium Chloride

Benzalkonium Chloride

NDC Product Code 33992-8991

NDC 33992-8991-1

Package Description: 369 g in 1 BOTTLE

NDC Product Information

Benzalkonium Chloride with NDC 33992-8991 is a a human over the counter drug product labeled by Greenbrier International, Inc.. The generic name of Benzalkonium Chloride is benzalkonium chloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Greenbrier International, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Benzalkonium Chloride 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 1.2 mg/g

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.

  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • LAURIC MONOETHANOLAMIDE (UNII: 098P2IGT76)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-150 STEARATE (UNII: 7BSG7DF10Q)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • 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.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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: Greenbrier International, Inc.
Labeler Code: 33992
FDA Application Number: part333E 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: 08-25-2020 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.

Benzalkonium Chloride Product Label Images

Benzalkonium Chloride 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 IngredientBenzalkonium chloride 0.12%

Otc - Purpose

PurposeAntibacterial

Use In Specific Populations

  • UsesFor handwashing to decrease bacterial on the skin

Warnings

WarningsFor external use only.When using this product avoid contact with eyes. In case of eye contact, fluse with water.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Dosage & Administration

  • DirectionsPump into hands, wet as need.Lather vigorously for at least 15 secondsWash skin, rinse thoroughly and dry.

Inactive Ingredient

Inactive Ingredientswater, sodium laureth sulfate, cocamide methyl MEA, sodium chloride, peg-150 distearate, fragrance, citric acid, methylisothiazolinone, red 40, yellow 5, blue 1

Indications & Usage

DISTRIBUTED BY:GREENBRIER INTERNATIONAL, INC.500 VOLVO PARKWAY, CHESAPEAKE, VA 23320MADE IN CHINA

* Please review the disclaimer below.