ANTIBACTERIAL HAND DISINFECTANT SOLUTION- ethyl alcohol liquid

Antibacterial Hand Disinfectant Solution by

Drug Labeling and Warnings

Antibacterial Hand Disinfectant Solution by is a Otc medication manufactured, distributed, or labeled by KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

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

PURPOSE

Purpose: Antiseptic

INDICATIONS & USAGE

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

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.

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

DOSAGE & ADMINISTRATION

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

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 (%): 

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

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND DISINFECTANT SOLUTION 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78433-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78433-201-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
2	NDC: 78433-201-02	10 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/21/2020
3	NDC: 78433-201-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
4	NDC: 78433-201-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
5	NDC: 78433-201-05	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
6	NDC: 78433-201-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
7	NDC: 78433-201-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
8	NDC: 78433-201-08	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
9	NDC: 78433-201-09	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
10	NDC: 78433-201-10	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020
11	NDC: 78433-201-11	20000 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/21/2020
12	NDC: 78433-201-12	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/21/2020

Labeler - KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI (533111210)

Establishment
Name	Address	ID/FEI	Business Operations
KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI		533111210	manufacture(78433-201)