HAND SANITIZER GEL- alcohol gel

HAND SANITIZER gel by

Drug Labeling and Warnings

HAND SANITIZER gel by is a Otc medication manufactured, distributed, or labeled by Cellicon Lab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 70.3% w/w

Purpose

Antimicrobial

Use

• Hand sanitizer to help decrease bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using the product

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water, Glycerin, Carbomer, Polyacrylate Crosspolymer-6, Octyldodeceth-16, Tromethamine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Butylene Glycol, t-Butyl Alcohol, 1,2-Hexanediol, Portulaca Oleracea Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81601-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.703 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
OCTYLDODECETH-16 (UNII: RJV574G0DE)
TROLAMINE (UNII: 9O3K93S3TK)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PURSLANE (UNII: M6S840WXG5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81601-001-01	65 mL in 1 TUBE; Type 0: Not a Combination Product	04/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/02/2021

Labeler - Cellicon Lab Inc. (689056488)

Registrant - Cellicon Lab Inc. (689056488)

Establishment
Name	Address	ID/FEI	Business Operations
Cellicon Lab Inc.		695097499	manufacture(81601-001)