NDC 78092-602 Securemax Antibacterial Hand Cleansing

Ethyl Alcohol, Benzalkonium Chloride

NDC Product Code 78092-602

NDC 78092-602-01

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-02

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-03

Package Description: 100 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-04

Package Description: 120 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-05

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-06

Package Description: 300 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-07

Package Description: 400 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-08

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-09

Package Description: 700 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-10

Package Description: 750 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-11

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-12

Package Description: 1500 mL in 1 BOTTLE, PLASTIC

NDC 78092-602-13

Package Description: 5000 mL in 1 CONTAINER

NDC 78092-602-14

Package Description: 10000 mL in 1 CONTAINER

NDC 78092-602-15

Package Description: 25000 mL in 1 CONTAINER

NDC 78092-602-16

Package Description: 30000 mL in 1 CONTAINER

NDC Product Information

Securemax Antibacterial Hand Cleansing with NDC 78092-602 is a a human over the counter drug product labeled by Atomizer Kozmetik Turizm Ve Yapi Sanayi Ticaret Anonim Sirketi. The generic name of Securemax Antibacterial Hand Cleansing is ethyl alcohol, benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Atomizer Kozmetik Turizm Ve Yapi Sanayi Ticaret Anonim Sirketi

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Securemax Antibacterial Hand Cleansing 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 70 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)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Atomizer Kozmetik Turizm Ve Yapi Sanayi Ticaret Anonim Sirketi
Labeler Code: 78092
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: 05-27-2020 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.

Securemax Antibacterial Hand Cleansing Product Label Images

Securemax Antibacterial Hand Cleansing 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

Ethyl Alcohol 70 %Benzalkonium Chloride 0.1 %Be sure to read the label before use.

Purpose

AntisepticAntibacterial

Use

  • To decrease bacteria on the skin and clean hands.Recommended for repeated use.

Warnings

For external use only. Flammable, keep away from fire or flame. Do not store above 40°C.Do not get into eyes.If contact occurs, rinse thoroughly with water.Discontinue use.If irritation or redness develops. If irritation persists for more than 72 hours, consult a doctor.

Directions

  • Apply to hands until thoroughly wet.Rub vigorously until dry.Supervise children in the use of this product.

Inactive Substances:

​29,15% Deionised water, 0,75% Glycerin.

Other

KILLS 99,9% OF BACTERIA* /RINSE-FREE /WITH MOISTURIZER /70 0ETHANOLSECUREMAX Antibacterial hand cleansing liquid has been developed especially to ensure effective protection of the hands against tested bacteria. It kills 99.9% of the tested bacteria (*). It has been proven to provide antibacterial protection against the microorganisms listed below (*).(*) Bacteria type tested under laboratory conditionsBacteria Type: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus hirae.Application Area and Usage: General Area-Hand and Skin. At least 3 ml solution is applied to the hand without dilution and rubbed until the hands are dry for 60 seconds. It is not necessary to rinse.Application Dose: Ready to Use.Application Range: It is used as often as desired.Poisoning Symptoms: None.Ethyl Alcohol: LD50: Acute oral-rat: 6200 mg/kg. Acute dermal rabbit: 7060 mg/kgBenzalkonium Chloride: LD50: (Acute oral-rat): 795 mg/kg., LD50:(Dermal rat)>5000 mg/kgAntidote and necessary information: There is no specific antidote known. Toxic for bees. It can be poisonous to fish and aquatic organisms.First Aid Measures:If inhaled: Remove patient to fresh air. If you feel unwell, consult a doctor. If swallowed: Rinse mouth with plenty of water and consult a doctor. In case of Eye Contact: If contact lenses are present, before washing the eyes, they should be removed. Open the eyelids and wash the eyes immediately with plenty of water. If the discomfort continues, consult a doctor. Hazard Statements and Descriptions: H225 Highly flammable liquid and vapour. H319 Causes serious eye irritation. Precautionary statements and Descriptions: P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground/bond container and receiving equipment. P241: Use explosion-proof electrical/ventilating/lighting/.../equipment. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/ shower. P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do - continue rinsing. P370+378: In case of fire: Use suitable fire extinguisher to extinguis​h. P337+P313: If eye irritation persists get medical advice/attention. P403+235: Store in a well-ventilated place. Keep cool. P501: Dispose of contents/container to in accordance with regional regulation. Keep away from children, food and animal feeds. Do not inhale vapors or particles. Do not eat or drink anything during application. Do not smoke. Store in the original packaging at a temperature below 30°C. Keep away from sunlight. Follow the instructions for use to avoid risks on human and environmental health. Use the opened product within 6 months. The shelf life of the product is 2 years under suitable storage conditions.ATTENTION USED EXTERNALLY, NOT DRINKING.Production Date:27/04/2020Expiry Date:27/04/2020ATOMİZER KOZMETİK TURİZM VE YAPI SAN. TİC. A.Ş.Esenevler Mah. Korupark Sok. No:1 Ümraniye/İstanbul, Turkey www.atomizer.com.trMADE IN TURKEY

* Please review the disclaimer below.