Active Ingredient(s)

Alcohol 80.16 % v/v. 73.68 % m/m Purpose: Antiseptic

Purpose

Topical Antiseptic

Use

Hand Sanitizer for the hygienic treatment of hands by
friction. For use when soap and water unavailable.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

001 L (000 mL) NDC: 82122-005-01

1000 ml - 1 liter Label

KLEAN 4 IN 1 HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82122-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73.68 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.35 g in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.8 g in 100 g
WATER (UNII: 059QF0KO0R)	24.68 g in 100 g
METHYL GLUCETH-20 (UNII: J3QD0LD11P)	0.13 g in 100 g
PEG-90 DIISOSTEARATE (UNII: YAE61SLW68)	0.25 g in 100 g
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.11 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82122-005-01	857 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/30/2021

Labeler - DepilatoCosmetics SAS (275215360)

Registrant - DepilatoCosmetics SAS (275215360)

Name	Address	ID/FEI	Business Operations
Establishment
DepilatoCosmetics SAS		275215360	manufacture(82122-005)

KLEAN 4 IN 1 Hand Sanitizer