HAND SANITIZER GEL- alcohol gel
Cellicon Lab 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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81601-001_HAND SANITIZER GEL

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

Product Label

HAND SANITIZER GEL
alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Cellicon Lab Inc. (689056488)

Registrant - Cellicon Lab Inc. (689056488)

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