Antibacterial Hand Disinfectant Solution

Manufacturer
KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-07-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:42

Label at a glance#

ProductAntibacterial Hand Disinfectant Solution
Active ingredientALCOHOL
Label structure9 sections

Storage and handling

Other information:  Things to consider while using and storing the product: Store in its original packaging upright in a cool dry place that does not receive sunlight. Do not store more than 4 boxes in a row.   Dispose of container P501 in accordance with local regulations.  Use the unpacked product within 1 month. Shelf life (25+/-2°C) of the product is 2 years. 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Content: Ethyl alcohol (CAS No: 64-17-5) %70, Alkyl dimethyl benzyl ammonium chloride (CAS No: 61789-71-7) % 0.2

OTC - PURPOSE SECTION

Purpose: Antiseptic

INDICATIONS & USAGE SECTION

Uses: Usage area and way: It is a disinfectant formulated for use in areas requiring high hygiene standards.

It's a hand rub product. No rinsing required. Special formula does not irritate or dry skin. It saves time

and ease of use. 

WARNINGS SECTION

Warnings: Symptoms of poisoning: Dizziness, nausea, redness of the skin. Ethyl alcohol LD50(OrAL Rat):

3450mg/kg, Dimethyl benzyl ammonium chloride LD50(OraL Rat): 410mg/kg First aid recommendations:

Respiratory: Fresh air should be taken and see a doctor immediately in case of weakness. Skin Contact:

No impact is expected. However, in case of redness, burning or itching on the skin, wash and rinse with

plenty of water. Contact your doctor if irritation persists. Eye contact: Wash with plenty of water while

keeping the eyelids open. Contact your doctor if eye irritation persists. Swallow: Rinse the mouth and

then drink 1-2 cups of water or milk. Do not vomit patient. see a doctor if symptoms persist. 

Show the product container or label to the doctor. Antidote and necessary information: It has no

specific antidote. Treatment is performed according to the symptoms. In cases of poisoning, call National

Poison Advisory Centre or your doctor. It can be poisonous to fish and aquatic organisms. It's toxic to bees.  

Risk statement and explanation: p305+P351+P338 In case of eye contact: Rinse carefully with water for a few

minutes. If you have contact lenses, remove them and keep rinsing. Do not use in areas where pregnant women, 

infants and people with respiratory problems are present.

Do not swallow.

Avoid prolonged contact to protect your skin. Keep away from foodstuffs.

Do not breathe directly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. It can cause allergies. 

DOSAGE & ADMINISTRATION SECTION

Directions:

    Harmful organisms affected by the product
 Type of Pest Application Area
Mananer &
 Application dose Application Range
 Esherichia coli
Salmonella, typhi
murium, Bacillus cereus S.aereus.
 It is used to clean
hands in public and personal areas. It
does not require
rinsing.
 Use enough amount
of solution to keep
your hands
wet. Rub your hands
at least 30 seconds.
 When. Required.

STORAGE AND HANDLING SECTION

Other information: Things to consider while using and storing the product: Store in its original

packaging upright in a cool dry place that does not receive sunlight.

Do not store more than 4 boxes in a row.  

Dispose of container P501 in accordance with local regulations. 

Use the unpacked product within 1 month. Shelf life (25+/-2°C) of the product is 2 years. 

Excipients and its amounts (%): 

INACTIVE INGREDIENT SECTION

Water % 27.5, Glycerine % 2.0, Carbomer %1.0

SPL UNCLASSIFIED SECTION

Quality in our chemistry

% 70 Alcohol

ATTENTION! ONLY FOR EXTERNAL USE. DO NOT DRINK

Type of product: Product related to human hygiene.

Manufacture date and lot no is on the package.

MADE IN TURKEY

Formulation: Liquid

Users Group: People

Keep away from children, food and animal feed. Do not use in cleaning of foodstuffs. Do not eat, drink,

or smoke during the application and preparation phase. Follow the instructions to avoid risks to human 

and environmental health.

Empty packaging way of dispose: Properly dispose of accordance the rule.

Ministry of Health License

Date and Number 04.06.2020/G181

Manufacturer and Licensee Firm and Name and Address:

KOCKAR

Makina Kimya san. ve Tic. A. S.

Tel: 0 264 418 18 67 - Fax: 418 48 69

Adres: Fatih Mh. 9008 Sk. No:121 Akyazi / SAKARYA 

www.wieberr.com.tr / info@wieberr.com.tr

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78433-201-012021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-022021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-032021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-042021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-052021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-062021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-072021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-082021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-092021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-102021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-112021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION
78433-201-122021-07-23C16284748780-1c7ccaba7-2aa5-fd44-e053-dadaa90aa01bWIEBERR ® ANTIBACTERIAL HAND DISINFECTANT SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78433-201-01Antibacterial Hand Disinfectant Solution5 mL in 1 BOTTLELIQUID51
78433-201-02Antibacterial Hand Disinfectant Solution10 mL in 1 BOTTLELIQUID101
78433-201-03Antibacterial Hand Disinfectant Solution50 mL in 1 BOTTLELIQUID501
78433-201-04Antibacterial Hand Disinfectant Solution100 mL in 1 BOTTLELIQUID1001
78433-201-05Antibacterial Hand Disinfectant Solution200 mL in 1 BOTTLELIQUID2001
78433-201-06Antibacterial Hand Disinfectant Solution250 mL in 1 BOTTLELIQUID2501
78433-201-07Antibacterial Hand Disinfectant Solution500 mL in 1 BOTTLELIQUID5001
78433-201-08Antibacterial Hand Disinfectant Solution750 mL in 1 BOTTLELIQUID7501
78433-201-09Antibacterial Hand Disinfectant Solution1000 mL in 1 BOTTLELIQUID10001
78433-201-10Antibacterial Hand Disinfectant Solution5000 mL in 1 BOTTLELIQUID50001
78433-201-11Antibacterial Hand Disinfectant Solution20000 mL in 1 CONTAINERLIQUID200001
78433-201-12Antibacterial Hand Disinfectant Solution1000000 mL in 1 CONTAINERLIQUID10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78433-201ANTIBACTERIAL HAND DISINFECTANT SOLUTION (ETHYL ALCOHOL) LIQUID [KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 12 package rows20200805_161c2319-71b6-44ba-b45d-c5a191a200db.zip

Products#

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
2183defb-dbf4-4eb1-b76a-d66635655d0f161c2319-71b6-44ba-b45d-c5a191a200db2020-07-21WarningsExact identifier
spl id: 2183defb-dbf4-4eb1-b76a-d66635655d0f
spl set id: 161c2319-71b6-44ba-b45d-c5a191a200db

Reported adverse events (FAERS/openFDA)#

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