Antimicrobial Hand Purifier by Quantum Fluids LLC / Kleen Concepts Drug Facts

Antimicrobial Hand Purifier by

Drug Labeling and Warnings

Antimicrobial Hand Purifier by is a Otc medication manufactured, distributed, or labeled by Quantum Fluids LLC, Kleen Concepts. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KLEEN ANTIMICROBIAL HAND PURIFIER- ethyl alcohol liquid 
Quantum Fluids 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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Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Hand & Skin Antiseptic

Uses

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin.

Warnings

For external use only.

Flammable. Keep away from heat and flame.

*Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

If irritation or redness develops, and/or you have open wounds or serious burns.

* If irritation or redness develops

* Have open wounds or serious burns

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

* Spray enough product in your palm to thoroughly cover your hands.

* Rub hands together briskly until dry.

* Children under 6 years of age should be supervised when using this product.

Purified water, 1-Octaecanaminium,N,N-dimethyl-N-(3-trihydroxysilyl)-propyl)-cloride, Fragrance

Kleen Antimicrobial Hand Purifier

Destroys/Defends/Protects

24HR Extended Protection

Water resistant

1 application = 2,880 applications of the leading heand sanitizer

A revolutionary technology that eliminates 99.99% of Germs

Kleen Concepts Powered by CleanQ technologies

Distributed by:

Quantum Fluids LLC, 208 Hewitt Dr. Suite 103-113, Woodaway, TX 76712

(c)2020 Quantum Fluids, LLC. All Rights Reserved.

xx oz (zzzml) NDC: 79418-002-xx

KLEEN ANTIMICROBIAL HAND PURIFIER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79418-002
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
WATER (UNII: 059QF0KO0R)
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79418-002-02	59.15 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2020	10/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/19/2020	10/29/2020

Labeler - Quantum Fluids LLC (117560791)

Registrant - Quantum Fluids LLC (117560791)

Establishment
Name	Address	ID/FEI	Business Operations
Kleen Concepts		012989797	manufacture(79418-002) , pack(79418-002) , repack(79418-002)

Establishment
Name	Address	ID/FEI	Business Operations
Quantum Fluids LLC		117560791	label(79418-002) , relabel(79418-002)

Revised: 10/2020

Document Id: b2eb24e5-d9e9-d54f-e053-2a95a90a0f62

34390-5

Set id: ad3ffc2d-ebf0-6727-e053-2995a90aeba8

Version: 5

Effective Time: 20201030