KLEEN HANDZ ANTISEPTIC HAND SANITIZER GEL 

KLEEN HANDZ ANTISEPTIC SANITIZER by

Drug Labeling and Warnings

KLEEN HANDZ ANTISEPTIC SANITIZER by is a Otc medication manufactured, distributed, or labeled by Kleerspex Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KLEEN HANDZ ANTISEPTIC SANITIZER- ethyl alcohol gel 
Kleerspex Group 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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KLEEN HANDZ ANTISEPTIC HAND SANITIZER GEL 

Drug Facts

Active ingredient

Ethyl Alcohol 73%

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 the 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

water, glycerin, hydroxypropylcellulose, lauryl lactate, myristyl lactate, cetyl lactate

Questions? 

+1-763-544-1851
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM–5:00 PM

Manufactured by: KleerSpex Group LLC, 668 Mendelssohn Ave N, Golden Valley, MN 55427.
Lot no :

Expiry :

KleerSpex

• a hydroalcoholic gel for reducing bacteria on hands
• delivers a luxurious smooth and silky skin feel
• dispenses easily and spreads quickly
• refreshes skin

Packaging

KLEEN HANDZ ANTISEPTIC SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77884-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
LAURYL LACTATE (UNII: G5SU0BFK7O)
MYRISTYL ACETATE (UNII: G9O55CT350)
CETYL ACETATE (UNII: 4Q43814HXS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77884-339-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/29/2020	05/14/2021
2	NDC: 77884-339-08	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/29/2020	05/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/29/2020	05/14/2021

Labeler - Kleerspex Group LLC (056361816)

Establishment
Name	Address	ID/FEI	Business Operations
Kleerspex Group LLC		056361816	manufacture(77884-339)

Revised: 10/2021

Document Id: db731c5e-00a5-4238-9f7c-298137c48135

34390-5

Set id: 489a1101-3176-4154-8ab9-c27c3098f4f3

Version: 2

Effective Time: 20211027