DISINFECTING WIPES- alcohol cloth

DISINFECTING WIPES by

Drug Labeling and Warnings

DISINFECTING WIPES 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

Ethanol 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 15-30C (59-86F)
• avoid freezing and excessive heat above 40C (104F)

Inactive ingredients 

10mg glycerin, 10mg Butylene glycol, 10mg Perfume, ,365mg Aqua 10 mg Lanolin

SPL UNCLASSIFIED SECTION

Kills 99,99% of Germs

Import Company:

Hand Sanitizer, LLC

On Time Inventory

850 Kaliste Saloom Rd, Lafayette, La 70508.

www.handsanitizerllc.com

Manufactured: Necm Kimya Akaryakıt Ürünleri Medikal Malzemeler San. ve Tic. Ltd. Şti.

COUNTRY OF ORIGIN TURKEY

Open lid and pull out the first wipe.

Pull wipe apart at the perforated seam.

Keep container tighthy closed to keep wipes from drying out.

Do Not Flush

Packaging

INGREDIENTS AND APPEARANCE

DISINFECTING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79455-002
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
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79455-002-01	1 in 1 PACKET	07/13/2020
1		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 79455-002-02	50 in 1 CONTAINER	07/13/2020
2		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 79455-002-03	70 in 1 CONTAINER	07/13/2020
3		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 79455-002-04	72 in 1 CONTAINER	07/13/2020
4		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 79455-002-05	80 in 1 CONTAINER	07/13/2020
5		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC: 79455-002-06	100 in 1 CONTAINER	07/13/2020
6		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
7	NDC: 79455-002-07	120 in 1 CONTAINER	07/13/2020
7		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
8	NDC: 79455-002-08	150 in 1 CONTAINER	07/13/2020
8		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
9	NDC: 79455-002-09	200 in 1 PAIL	07/13/2020
9		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
10	NDC: 79455-002-10	250 in 1 PAIL	07/13/2020
10		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
11	NDC: 79455-002-11	350 in 1 PAIL	07/13/2020
11		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
12	NDC: 79455-002-12	400 in 1 PAIL	07/13/2020
12		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
13	NDC: 79455-002-13	750 in 1 PAIL	07/13/2020
13		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
14	NDC: 79455-002-14	1000 in 1 PAIL	07/13/2020
14		5 mL in 1 PACKAGE; Type 0: Not a Combination Product

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(79455-002)