NDC 73923-0110 Kosette Sanitizer Wipes

Benzalkonium Chloride

NDC Product Code 73923-0110

NDC 73923-0110-1

Package Description: 108 g in 1 CONTAINER

NDC 73923-0110-2

Package Description: 432 g in 1 CONTAINER

NDC Product Information

Kosette Sanitizer Wipes with NDC 73923-0110 is a a human over the counter drug product labeled by Firstcham Co., Ltd. The generic name of Kosette Sanitizer Wipes is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Firstcham Co., Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Kosette Sanitizer 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 g/100g

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)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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: Firstcham Co., Ltd
Labeler Code: 73923
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: 05-01-2020 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.

Kosette Sanitizer Wipes Product Label Images

Kosette Sanitizer 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 0.1%

Inactive Ingredient

Water, Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Tocopheryl acetate, Citric acid

Purpose

Antiseptic

Keep Out Of Reach Of Children

■ If swallowed, get medical help or contact a Posion Control Center right away

Uses

■ Instant hand antiseptic to decrease bacteria on the skin

Warnings

WarningsFor external use onlyStop use and ask a doctor if■ hypersensitivity symptoms such as erythema, itching and dermatitis happen■ skin irritation happensDo not use■ in combination with soap or antibacterial cleansing agents■ the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skinWhen using this product■ avoid using repeatedly in the same area, skin irritation may occur■ avoid getting into the eyes (if contact occurs, wash well with clean water)■ if following abnormal symptoms persist, discontinue use: Irritation around the eyes, ears, mucous membranes, including the mouth, skin irritation, and rashes

Directions

■ Wet hands thoroughly with product and allow to dry without wiping■ Do not flush

Other Information

■ Read the directions and warnings before use ■ Avoid freezing and excessive heat above 40 ℃ (104 ℉)

* Please review the disclaimer below.