ALCOCLEAN HAND SANITIZER- ethyl alcohol gel

AlcoClean Hand Sanitizer by

Drug Labeling and Warnings

AlcoClean Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ALCOCLEAN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-095-08	236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/27/2020

Labeler - GADAL Laboratories, Inc (841305639)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	manufacture(53113-095)