BENZOCLEAN HAND SANITIZER- benzalkonium chloride gel 
GADAL Laboratories, Inc

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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BENZOCLEANTM HAND SANITIZER

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use ▪ For handwashing to decrease bacteria on the skin.

Warnings For external use only. Do not use ▪ in the eyes Stop use and ask a doctor if ▪ irritation and redness develop ▪ if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions ▪ Place enough product in your palm to thoroughly cover your hands. ▪ Rub hands together briskly until dry. ▪ No rinsing required. No towels needed.

Other information Store at room temperature.

Inactive ingredients Water (Aqua), Aloe Barbadensis Leaf Juice, Disodium EDTA, DMDM Hydantoin, Fragrance, Glycerin, Hydroxyethylcellulose, Sodium Chloride, Tocopheryl Acetate.

ADVANCED

MOISTURIZING 

LONG-LASTING GEL

WITH ALOE VERA & VITAMIN E

KILLS 99.9% OF GERMS

*Kills Most Viruses

*Moisturizes & Leaves

Hands Feeling Smooth

MADE IN THE USA

GMP GOOD MANUFACTURING PRACTICE QUALITY PRODUCT 

Distributed by: PCO Foods • 1110 Powers Place Alpharetta, GA, 30009 • pcofoods.com Questions or comments: sales@pcofoods.com

Packaging

untitled

BENZOCLEAN HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-090-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2020
Labeler - GADAL Laboratories, Inc (841305639)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639manufacture(53113-090)

Revised: 7/2020
Document Id: d8c763e5-497e-4b5f-8b0c-a54b20b92a95
Set id: f0bbce8a-6b5a-4f4c-8041-701685b05648
Version: 1
Effective Time: 20200711
 
GADAL Laboratories, Inc