ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

ANTISEPTIC HAND SANITIZER 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

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

▪ hand sanitizer to decrease bacteria on the skin

▪ recommended for repeated use

▪ for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

▪ in children less than 2 months of age

▪ on open skin wounds

When using this product

▪ do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

▪ irritation and redness develop

▪ condition persists for more than 72 hours

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

Directions

▪ wet hands thoroughly with product and allow to dry without wiping

▪ supervise children under 6 years of age when using this product to avoid swallowing

Other information

▪ store between 15-30°C (59-86°F)

▪ avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

carbomer, glycerin, water

Questions?

+1-410-441-4610

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Quality in our chemistry

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

Ministry of Health License Date and Number 27.03.2020-202079

Manufactured for:

KOÇKAR

Makina Kimya San. ve Tic. A.S.

Fatih Mh. 9008 Sk. No: 121

AkyazI, SAKARYA, TURKEY 54400

COUNTRY OF ORIGIN: TURKEY

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

Packaging

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78433-101
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78433-101-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
2	NDC: 78433-101-02	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
3	NDC: 78433-101-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
4	NDC: 78433-101-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
5	NDC: 78433-101-05	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
6	NDC: 78433-101-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
7	NDC: 78433-101-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
8	NDC: 78433-101-08	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
9	NDC: 78433-101-09	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
10	NDC: 78433-101-10	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
11	NDC: 78433-101-11	20000 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/07/2020
12	NDC: 78433-101-12	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/07/2020

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

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(78433-101)