NDC 81197-000 Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent

Benzalkonium Chloride

NDC Product Code 81197-000

NDC CODE: 81197-000

Proprietary Name: Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent 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

  • 81197 - Ironcompany.com, Llc
    • 81197-000 - Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent

NDC 81197-000-08

Package Description: 800 PATCH in 1 BAG > 4.1 mL in 1 PATCH

NDC Product Information

Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent with NDC 81197-000 is a a human over the counter drug product labeled by Ironcompany.com, Llc. The generic name of Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Ironcompany.com, 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.

Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent 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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Ironcompany.com, Llc
Labeler Code: 81197
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: 12-15-2020 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.

Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent Product Label Images

Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent 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 Ingredients

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

• For hand sanitizing to decrease bacteria on the skin.


• Apply topically to the skin to help prevent cross contamination.


• Recommended for repeated use.


• Dries in seconds.

Warnings

• For external use only


• May irritate eyes

Keep Out Of The Reach Of Children

Unless under adult supervision

Directions

• Tear V notch on top of plastic bag.


• Pull first wipe from the center of roll up through opening of bag.


• Thread first wipe through the dispensing nozzle in lid of floor stand or dispenser.


• Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

Inactive Ingredients

Water (Aqua), Propylene Glycol, Polysorbate 20, Disodium Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate,


Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance.

* Please review the disclaimer below.