NDC 81731-403 Bortek Foaming Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 81731-403

NDC 81731-403-01

Package Description: 1000 mL in 1 CONTAINER

NDC Product Information

Bortek Foaming Hand Sanitizer with NDC 81731-403 is a a human over the counter drug product labeled by Bortek Industries. The generic name of Bortek Foaming Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Bortek Industries

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.

Bortek Foaming Hand Sanitizer 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 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.

  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
  • WATER (UNII: 059QF0KO0R)

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: Bortek Industries
Labeler Code: 81731
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: 04-12-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Bortek Foaming Hand Sanitizer Product Label Images

Bortek Foaming Hand Sanitizer 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

Drug Facts

Otc - Active Ingredient

Active IngredientBenzalkonium Chloride 0.1% w/w

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • UsesHandwash to decrease bacteria on the skin that can potentially cause disease.Recommended for repeated use.

Warnings

WarningsFor external use only.

Otc - When Using

Keep out of eyes, ears or mouth. In case of contact, flush eyes with water,

Otc - Stop Use

  • Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • DirectionsPump sufficient amount of foam into palm of hand.We all surfaces of both hands thoroughly with product, including area under the finger nails until dry.

Inactive Ingredient

Inactive ingredientsCetrimonium chloride, lautrimonium chloride, phenoxyethanol, stearalkonium chloride, water.

Otc - Questions

Questions? Call 800.626.7835 or visit our website sweeperland.com

* Please review the disclaimer below.