ANTISEPTIC HAND SANITIZER- alcohol liquid

ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

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

1,3-butandiol, glycerin, isopropyl alcohol, lanolin, fragrance, water

SPL UNCLASSIFIED SECTION

Import Company: Purple Dice LLC

+1-971-235-1506

Monday-Friday 9:00 AM - 5:00 PM

Manufactured by: NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED
SIRKETI, AYTOP GIDA SITE I BLOK, NO:14-1 B GAZI MAHALLESI SARK CADDESI GULGONCASI SOKAK,
SULTANBEYLI, Istanbul (Anatolia), Turkey 34920

COUNTRY OF ORIGIN: TURKEY

Packaging

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79455-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LANOLIN (UNII: 7EV65EAW6H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79455-001-01	0.03 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
2	NDC: 79455-001-02	0.05 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
3	NDC: 79455-001-03	0.1 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
4	NDC: 79455-001-04	0.25 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
5	NDC: 79455-001-05	0.5 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
6	NDC: 79455-001-06	0.7 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
7	NDC: 79455-001-07	1 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
8	NDC: 79455-001-08	2 L in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
9	NDC: 79455-001-09	5 L in 1 CAN; Type 0: Not a Combination Product	07/13/2020
10	NDC: 79455-001-10	10 L in 1 CAN; Type 0: Not a Combination Product	07/13/2020
11	NDC: 79455-001-11	20 L in 1 DRUM; Type 0: Not a Combination Product	07/13/2020
12	NDC: 79455-001-12	30 L in 1 DRUM; Type 0: Not a Combination Product	07/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/13/2020

Labeler - NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI (355742649)

Establishment
Name	Address	ID/FEI	Business Operations
NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI		355742649	manufacture(79455-001)