NDC 78564-002 Bittol Anti-bacterial Liquid

Benzalkonium Chloride

NDC Product Code 78564-002

NDC CODE: 78564-002

Proprietary Name: Bittol Anti-bacterial Liquid What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 78564-002-01

Package Description: 250 mL in 1 BOTTLE

NDC 78564-002-02

Package Description: 500 mL in 1 BOTTLE

NDC 78564-002-03

Package Description: 1000 mL in 1 BOTTLE

NDC Product Information

Bittol Anti-bacterial Liquid with NDC 78564-002 is a a human over the counter drug product labeled by Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi. The generic name of Bittol Anti-bacterial Liquid is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi

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.

Bittol Anti-bacterial Liquid 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 1.3 mg/mL

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)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • MYRISTAMINE OXIDE (UNII: J086PM3RRT)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
Labeler Code: 78564
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: 09-20-2020 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.

Bittol Anti-bacterial Liquid Product Label Images

Bittol Anti-bacterial Liquid 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 Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

  • For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When Using This Product:

Do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If:

Irritation and redness develops and last more than 72 hours.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

Directions:

The pump to get some up Bittol Antibacterial Liquid Soap on your hand,lather it and wash your hands with very will.

Inactive Ingredients:

Aqua/Water, Lauramine Oxide, PEG-150 Distearate, Cetrimonium Chloride, Myristamine Oxide, Coco-Glucoside, Glyceryl Oleate, Glycerin, Parfum/Fragrance, Disodium EDTA, Sodium Chloride, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow 5.

* Please review the disclaimer below.