NDC 81105-002 Arabsabio Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 81105-002

NDC 81105-002-01

Package Description: 100 mL in 1 BOTTLE

NDC 81105-002-02

Package Description: 20 mL in 1 BOTTLE

NDC 81105-002-05

Package Description: 500 mL in 1 BOTTLE

NDC 81105-002-25

Package Description: 250 mL in 1 BOTTLE

NDC 81105-002-50

Package Description: 5000 mL in 1 CAN

NDC Product Information

Arabsabio Hand Sanitizer with NDC 81105-002 is a a human over the counter drug product labeled by Multiplex Bio-tech Private Limited. The generic name of Arabsabio Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Multiplex Bio-tech Private Limited

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.

Arabsabio Hand Sanitizer 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.

  • WATER (UNII: 059QF0KO0R)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Multiplex Bio-tech Private Limited
Labeler Code: 81105
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: 03-01-2021 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.

Arabsabio Hand Sanitizer 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

Otc - Active Ingredient

Benzalkonium Chloride 0.13%

Otc - Purpose

Hand & Skin Antiseptic

Indications & Usage

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin.


For external use only.

Otc - Do Not Use

Avoid contact with eyes.If eye contact occurs, rinse throughly with water.

Otc - Ask Doctor

If irritation or redness develops or persists for 72 hours.

Otc - Keep Out Of Reach Of Children

Children should be supervised when using this product

Dosage & Administration

Apply 5 to 6 drops each use to clearn and protect handsWork thoroughly onto hands and allow it to dry without wipingReapply as needed. Rpeat application increases effectiveness.

Inactive Ingredient

Glycerin, Vitamin E, Proprietary blend of Metabolites, Deionized water.

Otc - Questions

Call customer care cell: 080-2349-3692

* Please review the disclaimer below.