GEL Hand Sanitizer by KleerSpex

Gel SANITIZER BY Kleerspex by

Drug Labeling and Warnings

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

Drug Details [pdf]

GEL SANITIZER BY KLEERSPEX- isopropyl 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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GEL Hand Sanitizer by KleerSpex

Drug Facts

Active ingredient 

Isopropyl Alcohol 75% v/v 

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
on 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

Other information 

store between 15-30°C (59-86°F)
avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients 

acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera leaf juice, aminomethylpropanol, fragrance, glycerin, water

Questions? 

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

a hydroalcoholic gel for reducing bacteria on hands
delivers a luxurious smooth and silky skin feel
dispenses easily and spreads quickly
refreshes skin
kills most illness-causing germs
made in USA

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

Expiry:

Packaging

GEL SANITIZER BY KLEERSPEX 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77884-668
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77884-668-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	05/14/2021
2	NDC: 77884-668-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	05/14/2021
3	NDC: 77884-668-99	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	05/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/17/2020	05/14/2021

Labeler - Kleerspex Group LLC (056361816)

Establishment
Name	Address	ID/FEI	Business Operations
Kleerspex Group LLC		056361816	relabel(77884-668) , repack(77884-668)

Revised: 10/2021

Document Id: 36a69d5a-f751-41ff-8295-f68d4525e3a8

34390-5

Set id: c7c0b8fa-46ea-4088-aa09-2be471db23a6

Version: 2

Effective Time: 20211027