ALCOCLEAN HAND SANITIZER- ethyl alcohol 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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AlcoClean HAND SANITIZER

Drug Facts

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine.

Directions

Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using.

Warning

Flammable. Keep away from flames. Keep out of eyes. In case of eye contact immediately flush eyes with water then contact physician. If swallowed, contact physician. For external use only. Do not store above 110°F.

Keep out of reach of children.

Other Information

Store at room temperature.

Made with 65% Alcohol

Kills 99.9% of germs!

Eliminates Harmful Bacteria
Leaves Hands Feeling Refreshed

GOOD MANUFACTURING PRACTICE

GMP

QUALITY PRODUCT

MADE IN THE USA

PCO FOODS

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

Packaging

IMAGE

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ALCOCLEAN HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-095-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/27/2020
Labeler - GADAL Laboratories, Inc (841305639)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639manufacture(53113-095)

Revised: 7/2020
Document Id: 05123524-843a-492b-b843-2ae86474c7a5
Set id: 2a370cac-47ae-47d3-b161-f9d705bbf667
Version: 2
Effective Time: 20200724
 
GADAL Laboratories, Inc