QUATRO SHIELD HAND SANITIZER by QUATRO SHIELD LLC / HARDAL GLOBAL CONSULTING LLC. / QUATRO KIMYA SANAYI TICARET LIMITED SIRKETI HAND SANITIZER

QUATRO SHIELD HAND SANITIZER by

Drug Labeling and Warnings

QUATRO SHIELD HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by QUATRO SHIELD LLC, HARDAL GLOBAL CONSULTING LLC., QUATRO KIMYA SANAYI TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

QUATRO SHIELD HAND SANITIZER- benzalkonium chloride liquid 
QUATRO SHIELD LLC

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.

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HAND SANITIZER

ACTIVE INGREDIENT/PURPOSE

BENZALKONIUM CHLORIDE 0.10%

PURPOSE

ANTISEPTIC

USES

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE.

RECOMMENDED FOR REPEATED USE.

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON THE EYES

WHEN USING

WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGH WITH WATER.

STOP USE AND ASK A DOCTOR

Stop use and ask a doctor if irritation and redness develop.

DRUG FACTS (CONTINUED)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

APPLY LIBERALLY TO THE HANDS AND GENTLY RUB UNTIL DRY.

INACTIVE INGREDIENTS

SILICA COMPLEX 3-(TRIMETHOXYSILYL) PROPYL DIMETHYL OCTADECYL AMMONIUM CHLORIDE, GLYCERIN, WATER

QUESTIONS

TELEPHONE: 1-888-QUATRO-5

MONDAY THROUGH FRIDAY 8:00 AM UNTIL 5:00 PM EST

WATER BASED FORMULA

QUATRO SHIELD

LONG-LASTING PROTECTION

ALCOHOL-FREE

HAND SANITIZER

KILLS 99.9% OF GERMS

100 ML

3.38 FL OZ

Kills more than 99.99% of many common harmful germs and bacteria that may cause ilnness.

Distributed by:

Quatro Shield LLC

67 Plaza Fabiana

Vega Alta, PR 00692

www.Quatroshield.com

Product of Turkey

QUATRO SHIELD HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78873-607
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white (WATER-LIKE, CLEAR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78873-607-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020	07/02/2020

Labeler - QUATRO SHIELD LLC (117550310)

Registrant - HARDAL GLOBAL CONSULTING LLC. (123584960)

Establishment
Name	Address	ID/FEI	Business Operations
QUATRO SHIELD LLC		117550310	label(78873-607)

Establishment
Name	Address	ID/FEI	Business Operations
QUATRO KIMYA SANAYI TICARET LIMITED SIRKETI		595805184	manufacture(78873-607)

Revised: 6/2020

Document Id: a95054ab-3366-7a7e-e053-2995a90a75a4

34390-5

Set id: a7a3bca6-e6aa-049d-e053-2a95a90ad79b

Version: 3

Effective Time: 20200630