NDC 76725-102 Dr.clinic Antibacterial Cologne

Ethyl Alcohol, Benzalkonium Chloride

NDC Product Code 76725-102

NDC CODE: 76725-102

Proprietary Name: Dr.clinic Antibacterial Cologne 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: Ethyl Alcohol, 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 76725-102-01

Package Description: 100 mL in 1 BOTTLE

NDC 76725-102-02

Package Description: 240 mL in 1 BOTTLE

NDC 76725-102-03

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Dr.clinic Antibacterial Cologne with NDC 76725-102 is a a human over the counter drug product labeled by Makyaj Kozmetik Insaat Sanayi Ve Ticaret Limited Sirketi. The generic name of Dr.clinic Antibacterial Cologne is ethyl alcohol, benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Makyaj Kozmetik Insaat Sanayi Ve Ticaret 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.

Dr.clinic Antibacterial Cologne 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.

  • ALCOHOL 80 mL/100mL
  • 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.

  • 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: Makyaj Kozmetik Insaat Sanayi Ve Ticaret Limited Sirketi
Labeler Code: 76725
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: 05-06-2020 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’.

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Dr.clinic Antibacterial Cologne Product Label Images

Dr.clinic Antibacterial Cologne 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

Ethyl alcohol 80% (v/v)Benzalkonium Chloride 0.1% (v/v)

Purpose

Antibacterial

Inactive Ingredients

Deionized Water, Parfum

Use:

Antibacterial applied to the human body

Direction:

Take some Antibacterial cologne in your palm and rub your hands between fingers, all internal and external surfaces, nail parts until they are dry. It is used for hand cleaning. Do not rinse after use. It is necessary to use 60 seconds and 3 ml.

Warnings:

IN APPLICATION AND PREPARATION DO NOT EAT, DRINK, OR USE SMOKING. RISKS ON HUMAN AND ENVIRONMENTAL HEALTH TO AVOID, INSTRUCTIONS FOR USE FOLLOW. It is poisonous to bees. It can be poisonous to fish and aquatic organisms.Empty packaging disposal method: Do not empty into sewers or rivers.Used product: Do not discharge into sewers or rivers. Wastes not otherwise specifiedContaminated packaging: Do not reuse. Dispose according to local regulations.Symptoms of poisoning.Ethyl alcohol LD50 (oral): 10470 mg/kgFirst Aid MeasuresIn case of inhalation: In case of exposure, immediately remove the patient from the contaminated area.In case of eye contact: Rinse eyes immediately with clean water, keeping the eyelids open, for at least 15 minutes. Get help from an ophthalmologist.In case of swallowing: Rinse the mouth of the patient with water and drink water. Keep it calm. Do not induce vomiting.Antidote and necessary informationCALL 114NOUS PHONE OF NATIONAL POISON CONSULTING CENTER (UZEM) IN THE POISONING CONDITIONS. MATTERS TO BE CONSIDERED WHEN USING AND STORING THE PRODUCT HAZARDOUS EXPRESSION AND EXPLANATIONH225: Easily flammable liquid and vapor.GHS02 DANGER

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