NDC 79096-002 Biotop Professional Antiseptic Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 79096-002

NDC 79096-002-03

Package Description: 30 mL in 1 BOTTLE, PUMP

NDC 79096-002-05

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 79096-002-10

Package Description: 100 mL in 1 BOTTLE, PUMP

NDC 79096-002-12

Package Description: 120 mL in 1 BOTTLE, PUMP

NDC 79096-002-15

Package Description: 150 mL in 1 BOTTLE, PUMP

NDC 79096-002-18

Package Description: 180 mL in 1 BOTTLE, PUMP

NDC 79096-002-20

Package Description: 200 mL in 1 BOTTLE, PUMP

NDC 79096-002-25

Package Description: 250 mL in 1 BOTTLE, PUMP

NDC 79096-002-30

Package Description: 300 mL in 1 BOTTLE, PUMP

NDC 79096-002-50

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC 79096-002-70

Package Description: 70 mL in 1 BOTTLE, PUMP

NDC 79096-002-80

Package Description: 80 mL in 1 BOTTLE, PUMP

NDC Product Information

Biotop Professional Antiseptic Hand Sanitizer with NDC 79096-002 is a a human over the counter drug product labeled by G.v. Cosmetics Ltd. The generic name of Biotop Professional Antiseptic Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: G.v. Cosmetics 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.

Biotop Professional Antiseptic 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.

  • BENZALKONIUM CHLORIDE .1 g/100mL

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.

  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • BENZETHONIUM CHLORIDE (UNII: PH41D05744)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
  • .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.

Product Labeler Information

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

Labeler Name: G.v. Cosmetics Ltd
Labeler Code: 79096
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: 10-13-2020 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.

Biotop Professional Antiseptic Hand Sanitizer Product Label Images

Biotop Professional Antiseptic 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

Active Ingredient

Benzalkonium chloride 0.1%

Purpose

Antiseptic

Warnings

Flammable, keep away from fire/flameFor external use onlyDo not use • in children less than 2 months of age • on open skin woundsWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with waterStop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours

* Please review the disclaimer below.