NDC 82131-295 Homworks Antibacterial Hand Wipes

Benzalkonium Chloride

NDC Product Code 82131-295

NDC CODE: 82131-295

Proprietary Name: Homworks Antibacterial Hand Wipes 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.

Non-Proprietary Name: Benzalkonium Chloride 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.

NDC Code Structure

  • 82131 - Acadian Crossing Consumer Products, Llc.
    • 82131-295 - Homworks Antibacterial Hand Wipes

NDC 82131-295-80

Package Description: 80 CLOTH in 1 CANISTER

NDC Product Information

Homworks Antibacterial Hand Wipes with NDC 82131-295 is a a human over the counter drug product labeled by Acadian Crossing Consumer Products, Llc.. The generic name of Homworks Antibacterial Hand Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Homworks Antibacterial Hand Wipes 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.


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)
  • COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Acadian Crossing Consumer Products, Llc.
Labeler Code: 82131
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: 11-01-2021 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.

Homworks Antibacterial Hand Wipes Product Label Images

Homworks Antibacterial Hand Wipes 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

Drug Facts

Active Ingredient Benzalkonium Chloride 0.14% v/v

Otc - Purpose

PurposeAntimicrobial Agent

Use

Use • Reduce bacteria that can potentially cause disease.

Warnings

  • For External Use only: hands, general cleansing.Do not use • if you are allergic to any of the ingredients.
  • Does not replace wipes used for medical procedures.
  • When using this productDo not get into eyes. If contact occurs, rinse thoroughly with water.Avoid contact with broken skin.Stop use and ask doctor if irritation, rash or redness develops and continues 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.

Directions

Directions:• Adults and children over 2 years old: •Apply to hands

•Allow skin to dry without wiping
• Children under 2 years •Ask doctor before use• Single use wipes for hands. Close properly after dispensing to maintain purity.

Other Information

Keep out of light; store at room temperature 59ºF – 86ºF.

Inactive Ingredient

Water, Cocamidopropyl Dimethylamine, Glycerin, Cocamidopropyl Betaine, Fragrance.

Other Safety Information

Wipe Dimensions: 6” x 7.75” (15.2 cm x 19.6 cm)
www.HOM-works.com
Distributed by Acadian Crossing Consumer Products, LLC., San Antonio, TX 78232

* Please review the disclaimer below.