Active ingredient

Ethyl Alcohol 85% v/v

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin.
Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not usein or near the eyes or on mucous membranes.

In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping
Supervise children in the use of this product

Inactive ingredients

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Cyclomethicone, Glycerin, Isohexadecane, Isopropyl Alcohol, Myristyl Alcohol, PVP, Tetrahydroxypropyl Ethylenediamine, Water.

BODE

Sterillium Comfort Gel

HEALTHCARE

PERSONNEL HAND RUB

85% v/v ethyl alcohol with moisturizers

Kills > 99.999% of germs

in 15 seconds without water.

Boosts skin moisture level.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-009-06

1000 mL 33.8 fl.oz. (1QT 1.8 FL OZ)

container label

STERILLIUM COMFORT
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65616-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	85 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POVIDONE K90 (UNII: RDH86HJV5Z)
EDETOL (UNII: Q4R969U9FR)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
MYRISTYL ALCOHOL (UNII: V42034O9PU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65616-009-10	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2019	02/28/2023
2	NDC:65616-009-09	475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/31/2019
3	NDC:65616-009-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	07/31/2019

Labeler - BODE Chemie GmbH (316039007)