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

Active Ingredient                       

Ethyl Alcohol 85% w/w

INDICATIONS & USAGE

Uses

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS

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 or reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Apply to clean, dry hands, covering entire surface, including nails

Rub until dry

Supervise children in the use of this product

INACTIVE INGREDIENT

Inactive ingredients

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Cyclomethicone, Glycerin, Isohexa-decane, Myristyl Alcohol, PVP, Tetrahydroxypropyl Ethylenediamine, Water

PURPOSE

Purpose

Antiseptic

PRINCIPAL DISPLAY PANEL

BODE

Sterillium Comfort Gel

Health Care Personnel

Hand Antiseptic

85% w/w 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: 65616-003-07

1000ml 33.8 fl. oz.

INGREDIENTS AND APPEARANCE

STERILLIUM COMFORT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65616-003
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)
GLYCERIN (UNII: PDC6A3C0OX)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65616-003-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2009
2	NDC: 65616-003-09	475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/28/2009
3	NDC: 65616-003-07	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/28/2009
4	NDC: 65616-003-10	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/29/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2007	08/01/2023

Labeler - BODE Chemie GmbH (316039007)

Establishment
Name	Address	ID/FEI	Business Operations
BODE Chemie GmbH		316039007	manufacture(65616-003)