KOSETTE CARE HAND SANITIZER ALCOHOL-FREE- benzalkonium chloride gel

Kosette CARE Hand Sanitizer Alcohol-Free by

Drug Labeling and Warnings

Kosette CARE Hand Sanitizer Alcohol-Free by is a Otc medication manufactured, distributed, or labeled by Innovation Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.11%

Purpose

Antimicrobial

Uses

• To decrease bacteria on skin when soap and water is not available.
• Recommended for repeated use.

Warnings

• For external use only.

• When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water.

• Stop use and ask a doctor if skin irritation or redness develops and lasts.

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

Directions

• Place enough product in your palm to thoroughly cover your hands. Rub hands together until dry.
• Children under 6 years should be supervised when using this product.

Other information

• Read the directions and warnings before use.
• Store in a cool, dry and well-ventilated place.

Inactive ingredients

water(aqua), butylene glycol, propanediol, acrylates/c10-30 alkyl acrylate crosspolymer, caprylhydroxamic acid, caprylyl glyceryl ether, polyglyceryl-4 caprate, polyglyceryl-6 caprylate, potassium hydroxide, maltodextrin, moringa oleifera seed extract, frangrance(parfum)

Package Label - Principal Display Panel

Kosette

CARE

HAND SANITIZER

KILLS 99.9% OF GERMS

ALCOHOL-FREE

Safe for all, our gentle formula

effectively disinfects hands while

retaining skin's natural moisture

leaving it soft and smooth.

16.9 fl.oz / 500 ml

INGREDIENTS AND APPEARANCE

KOSETTE CARE HAND SANITIZER ALCOHOL-FREE 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73284-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0011 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)
POLYGLYCERIN-6 (UNII: M51422LRAM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73284-420-40	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Innovation Labs, Inc. (117109069)

Establishment
Name	Address	ID/FEI	Business Operations
Innovation Labs, Inc.		117109069	manufacture(73284-420)