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, Dynamic Laboratories, Inc.. 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.

----------

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

wet hands thoroughly with product and allow to dry without wiping
supervise children under 6 years of age when using this product

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

image description

GEL SANITIZER BY KLEERSPEX 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77884-866
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77884-866-0260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/202005/14/2021
2NDC: 77884-866-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/202005/14/2021
3NDC: 77884-866-993800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/202005/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/17/202005/14/2021
Labeler - Kleerspex Group LLC (056361816)
Establishment
NameAddressID/FEIBusiness Operations
Dynamic Laboratories, Inc.963542493manufacture(77884-866)

Revised: 10/2021
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.