INSTANT HAND SANITIZER GEL- ethyl alcohol gel

Instant Hand Sanitizer Gel by

Drug Labeling and Warnings

Instant Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 75%

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

• do not store in direct sunlight
• store below 50°C /105°F
• avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive ingredients carbomer, glycerin, triethanolamine, water

QUESTIONS

Questions? +1-917-471-1271
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

■ Antiseptic

■ Non Sticky

■ Scent Free

Distributed By

FRESH N CLEAR LLC

1 Passaic Ave Unit 6

Wood-Ridge, NJ, 07075

PRODUCT OF TURKEY

Email: info@freshnclear.com

nqa ISO 22718 Registered Quality Management

nqa ISO 9001 Registered Quality Management

U K A S MANAGEMENT SYSTEMS

N-114992/1              CE

N-114992

Packaging

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77550-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	750 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77550-101-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
2	NDC: 77550-101-51	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
3	NDC: 77550-101-52	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
4	NDC: 77550-101-53	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
5	NDC: 77550-101-54	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
6	NDC: 77550-101-55	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
7	NDC: 77550-101-56	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
8	NDC: 77550-101-57	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
9	NDC: 77550-101-58	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
10	NDC: 77550-101-59	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
11	NDC: 77550-101-60	1 in 1 BOX	05/19/2020
11		10000 mL in 1 CONTAINER; Type 0: Not a Combination Product
12	NDC: 77550-101-61	1 in 1 BOX	05/19/2020
12		20000 mL in 1 CONTAINER; Type 0: Not a Combination Product
13	NDC: 77550-101-62	1 in 1 BOX	05/19/2020
13		25000 mL in 1 CONTAINER; Type 0: Not a Combination Product
14	NDC: 77550-101-63	1 in 1 BOX	05/19/2020
14		30000 mL in 1 CONTAINER; 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	05/19/2020

Labeler - MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKETI (519846410)

Establishment
Name	Address	ID/FEI	Business Operations
MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKETI		519846410	manufacture(77550-101)