Label: ANTIBACTERIAL HAND DISINFECTANT SOLUTION- ethyl alcohol liquid
Contains inactivated NDC Code(s)
NDC Code(s): 78433-201-01, 78433-201-02, 78433-201-03, 78433-201-04, view more78433-201-05, 78433-201-06, 78433-201-07, 78433-201-08, 78433-201-09, 78433-201-10, 78433-201-11, 78433-201-12
- Packager: KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 21, 2020
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredient
- INDICATIONS & USAGE
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.
DOSAGE & ADMINISTRATION
Harmful organisms affected by the product Type of Pest Application Area
Application dose Application Range Esherichia coli
murium, Bacillus cereus S.aereus.
It is used to clean
hands in public and personal areas. It
does not require
Use enough amount
of solution to keep
wet. Rub your hands
at least 30 seconds.
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 (%):
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
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:
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 / firstname.lastname@example.org
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)