NDC 80171-002 Colemerg Antibacterial Hand Sanitizing Wipes

Benzalkonium Chloride

NDC Product Code 80171-002

NDC CODE: 80171-002

Proprietary Name: Colemerg Antibacterial Hand Sanitizing 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

  • 80171 - Colemerg Products Llc
    • 80171-002 - Colemerg Antibacterial Hand Sanitizing Wipes

NDC 80171-002-00

Package Description: 20 PATCH in 1 BAG > 3.2 mL in 1 PATCH

NDC Product Information

Colemerg Antibacterial Hand Sanitizing Wipes with NDC 80171-002 is a a human over the counter drug product labeled by Colemerg Products Llc. The generic name of Colemerg Antibacterial Hand Sanitizing Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Colemerg Products Llc

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.

Colemerg Antibacterial Hand Sanitizing 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.

  • BENZALKONIUM CHLORIDE 1.3 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)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Colemerg Products Llc
Labeler Code: 80171
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: 09-20-2020 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.

Colemerg Antibacterial Hand Sanitizing Wipes Product Label Images

Colemerg Antibacterial Hand Sanitizing 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

Active Ingredient

Benzalkonium Chloride 0.13 % w/v

Purpose

Antibacterial

Uses

  • For sanitizing to decrease bacteria on the skinRecommended for repeated use

Warnings

For external use only

Do Not Use:

Over large areas of the body if you are allegic to any of the ingredients.

When Using This Product

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

Irritation or rash develops and continues for more than 72 hours.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)

Directions

  • Remove lid and open the seal.Pull up the corner of the center sheet, twist it and thread through the dispenser slipt in the lid.Pull sheet out at an angle. When finished close lid flap to retain moisure.

Other Information:

  • Do not expose to direct sunlight, preferably place them in a cool placeDo not use on furnitureDo not flush down toilets, dispose in trash can

Inactive Ingredients:

Aqua/Water, Glycerin, Phenoxyethanol, Parfum/Fragrance, Polysorbate 20, Sodium PCA, Tetrasodium Edta, Ethylhexylglycerin, Citric Acid.

* Please review the disclaimer below.