NDC 73062-401 Benzalkonium Chloride

Dual Action Antimicrobial Wipes

NDC Product Code 73062-401

NDC 73062-401-01

Package Description: 150 CLOTH in 1 POUCH

NDC Product Information

Benzalkonium Chloride with NDC 73062-401 is a a human over the counter drug product labeled by Avro Enterprises Llc. The generic name of Benzalkonium Chloride is dual action antimicrobial wipes. 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.

Benzalkonium Chloride 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: Avro Enterprises Llc
Labeler Code: 73062
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: 10-26-2021 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.

Benzalkonium Chloride Product Label Images

Benzalkonium Chloride 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

Antimicrobial

Uses

For had washing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only. Do not use over large areas of the bosy or if you are allergic to any of these ingredients.

When Using This Product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If irritation or redness develops and persists for more than 72 hours.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • To use, peel back label, pull out wipe and firmly reseal label to maintain package moisture. Do not remove label.Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and throw away. After cleansing, dispose of wipe in a trash receptacle. Rub hands together briskly to dry.

Inactive Ingredients

Water, phenoxyethanol, decyl glucoside, potassium sorbate, sodium benzoate, disodium EDTA, citric acid, aloe barbadensis (aloe) leaf extract, fragrance.

* Please review the disclaimer below.