NDC 80473-010 Ikoo Care Hand Sanitizing Sheets

Benzalkonium Chloride

NDC Product Code 80473-010

NDC 80473-010-01

Package Description: 80 CLOTH in 1 PACKET

NDC Product Information

Ikoo Care Hand Sanitizing Sheets with NDC 80473-010 is a a human over the counter drug product labeled by Beauty-lab Llc. The generic name of Ikoo Care Hand Sanitizing Sheets is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Beauty-lab 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.

Ikoo Care Hand Sanitizing Sheets 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 .001 1/1

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)

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: Beauty-lab Llc
Labeler Code: 80473
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: 09-01-2020 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.

Ikoo Care Hand Sanitizing Sheets Product Label Images

Ikoo Care Hand Sanitizing Sheets 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 Ingredients

Citric acid, Disodium EDTA, Glycerin, Phenoxyethanol, Polysorbate 20, Sodium Benzoate, Tocopheryl acetate, Water(Aqua)

Purpose

Antiseptic

Warnings

For external use only--------------------------------------------------------------------------------------------------------Stop use and ask a doctor if■ hypersensitivity, skin irritation, or rash develops and persists--------------------------------------------------------------------------------------------------------Do not use■ in combination with soap or antibacterial cleansing agents--------------------------------------------------------------------------------------------------------When using this product■ avoid using repeatedly in the same area as skin irritation may occur■ avoid getting into the eyes (if contact occurs, wash well with clean water)■ if the following abnormal symptoms persist (irritation around the eyes, ears, mucous membranes, including the mouth, and skin rashes), discontinue use

Keep Out Of Reach Of Children

■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

■ Hand antiseptic to reduce bacteria that can potentially cause disease■ Instant antiseptic to decrease bacteria on the skin

Directions

■ Take a sheet from the package (more if needed), wipe hands and skin thoroughly, then let dry completely.

Other Information

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

Questions?

+ 1 (469) 676 9468

* Please review the disclaimer below.