STERILLIUM COMFORT- alcohol gel

Sterillium comfort by

Drug Labeling and Warnings

Sterillium comfort by is a Otc medication manufactured, distributed, or labeled by BODE Chemie GmbH, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 85 % v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use in 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

PRINCIPAL DISPLAY PANEL

Sterillium

comfort gel

Healthcare personnel Hand Rub

Kills > 99.999% of germs

in 15 seconds without water.

Boosts skin moisture level.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Hand Antiseptic Gel

85 % v/v ethyl alcohol with moisturizers

To decrease bacteria on the skin.

Recommended for repeated use.

Read drug facts panel before use.

Designed in Germany. Made in USA.

Lot:

Use by:

BODE

NDC: 65616-010-09

475 mL 16.06 fl. oz

INGREDIENTS AND APPEARANCE

STERILLIUM COMFORT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65616-010
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65616-010-09	475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/03/2025
2	NDC: 65616-010-20	2 in 1 CARTON	02/03/2025
2		475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 65616-010-21	4 in 1 CARTON	02/03/2025
3		475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4	NDC: 65616-010-22	8 in 1 CARTON	02/03/2025
4		475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	02/03/2025

Labeler - BODE Chemie GmbH (316039007)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(65616-010)