SECUREMAX Antibacterial Hand Cleansing Solution

Manufacturer
ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI
Effective date
2020-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:13

Label at a glance#

ProductSECUREMAX ANTIBACTERIAL HAND CLEANSING
Active ingredientALCOHOL, BENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70 %

Benzalkonium Chloride 0.1 %

Be sure to read the label before use.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Antibacterial

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

Inactive Substances:

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

KILLS 99,9% OF BACTERIA* /RINSE-FREE /WITH MOISTURIZER /70 0ETHANOL

SECUREMAX 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 conditions

Bacteria 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/kg

Benzalkonium Chloride: LD50: (Acute oral-rat): 795 mg/kg., LD50:(Dermal rat)>5000 mg/kg

Antidote 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:27/04/2020

Expiry Date:27/04/2020

ATOMİZER KOZMETİK TURİZM VE YAPI SAN. TİC. A.Ş.

Esenevler Mah. Korupark Sok. No:1 Ümraniye/İstanbul, Turkey www.atomizer.com.tr

MADE IN TURKEY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2372454benzalkonium chloride 0.1 % / ethanol 70 % Topical SolutionPSN1
2372454benzalkonium chloride 1 MG/ML / ethanol 0.7 ML/ML Topical SolutionSCD1
2372454benzalkonium chloride 0.1 % / ethanol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78092-602-012021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-022021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-032021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-042021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-052021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-062021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-072021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-082021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-092021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-102021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-112021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-122021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-132021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-142021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-152021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution
78092-602-162021-07-23C16284748780-1c7ccaba7-1086-fd44-e053-dadaa90aa01bSECUREMAX Antibacterial Hand Cleansing Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78092-602-01SECUREMAXANTIBACTERIAL HAND CLEANSING50 mL in 1 BOTTLE, PLASTICSOLUTION501
78092-602-02SECUREMAXANTIBACTERIAL HAND CLEANSING60 mL in 1 BOTTLE, PLASTICSOLUTION601
78092-602-03SECUREMAXANTIBACTERIAL HAND CLEANSING100 mL in 1 BOTTLE, PLASTICSOLUTION1001
78092-602-04SECUREMAXANTIBACTERIAL HAND CLEANSING120 mL in 1 BOTTLE, PLASTICSOLUTION1201
78092-602-05SECUREMAXANTIBACTERIAL HAND CLEANSING250 mL in 1 BOTTLE, PLASTICSOLUTION2501
78092-602-06SECUREMAXANTIBACTERIAL HAND CLEANSING300 mL in 1 BOTTLE, PLASTICSOLUTION3001
78092-602-07SECUREMAXANTIBACTERIAL HAND CLEANSING400 mL in 1 BOTTLE, PLASTICSOLUTION4001
78092-602-08SECUREMAXANTIBACTERIAL HAND CLEANSING500 mL in 1 BOTTLE, PLASTICSOLUTION5001
78092-602-09SECUREMAXANTIBACTERIAL HAND CLEANSING700 mL in 1 BOTTLE, PLASTICSOLUTION7001
78092-602-10SECUREMAXANTIBACTERIAL HAND CLEANSING750 mL in 1 BOTTLE, PLASTICSOLUTION7501
78092-602-11SECUREMAXANTIBACTERIAL HAND CLEANSING1000 mL in 1 BOTTLE, PLASTICSOLUTION10001
78092-602-12SECUREMAXANTIBACTERIAL HAND CLEANSING1500 mL in 1 BOTTLE, PLASTICSOLUTION15001
78092-602-13SECUREMAXANTIBACTERIAL HAND CLEANSING5000 mL in 1 CONTAINERSOLUTION50001
78092-602-14SECUREMAXANTIBACTERIAL HAND CLEANSING10000 mL in 1 CONTAINERSOLUTION100001
78092-602-15SECUREMAXANTIBACTERIAL HAND CLEANSING25000 mL in 1 CONTAINERSOLUTION250001
78092-602-16SECUREMAXANTIBACTERIAL HAND CLEANSING30000 mL in 1 CONTAINERSOLUTION300001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78092-602SECUREMAX ANTIBACTERIAL HAND CLEANSING (ETHYL ALCOHOL, BENZALKONIUM CHLORIDE) SOLUTION [ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI]1Legacy NDC, 16 package rows20200605_c6cbe63b-a81c-4f8f-b51f-e6b35e6c1bf8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a45387a7-c35c-405c-b4ef-155c1e4e7425c6cbe63b-a81c-4f8f-b51f-e6b35e6c1bf82020-05-27WarningsExact identifier
spl id: a45387a7-c35c-405c-b4ef-155c1e4e7425
spl set id: c6cbe63b-a81c-4f8f-b51f-e6b35e6c1bf8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.