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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 USE

Do not use in or near the eyes or on mucous membranes.

In case of contact, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

Directions

• Apply to clean, dry hands, covering entire surface,including nails
• Rub until dry
• 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

BODE

Sterillium Comfort Gel

HEALTHCARE PERSONNEL

HAND ANTISEPTIC

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.

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INGREDIENTS AND APPEARANCE

STERILLIUM COMFORT 
alcohol gel

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65616-009-10	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2019
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/31/2019

Labeler - BODE Chemie GmbH (316039007)