NDC 74811-002 Premium Antibacterial Hand

Benzalkonium Chloride

NDC Product Code 74811-002

NDC 74811-002-01

Package Description: 240 mL in 1 BOTTLE, PUMP

NDC 74811-002-02

Package Description: 354 mL in 1 BOTTLE, PUMP

NDC Product Information

Premium Antibacterial Hand with NDC 74811-002 is a a human over the counter drug product labeled by Insolcorp, Llc. The generic name of Premium Antibacterial Hand is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Insolcorp, Llc

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Premium Antibacterial Hand 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
  • 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)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
  • COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
  • 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: Insolcorp, Llc
Labeler Code: 74811
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: 12-08-2020 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.

Premium Antibacterial Hand Product Label Images

Premium Antibacterial Hand 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%

Purpose

Antibacterial

Use

For washing to decrease bacteria on the skin

Warnings

For external use only

Otc - When Using

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. Incase of eye contact flush with water.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF irritation and redness develops

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, get medical help or contact a poision control


center right away.

Directions

Pump into dry hands and forearms, lather for atleast 15 seconds, rinse and dry.

Inactive Ingredients

Water, Caprylyl / Capryl Glucosides, Laurtrimonium Chloride, Cocamidoprpylamine Oxide, Citric Acid, Fragrance

* Please review the disclaimer below.