FDA.reportPublic FDA data

Sterillium comfort

Manufacturer
BODE Chemie GmbH | Kutol Products Company
Effective date
2026-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:23

Label at a glance#

ProductSterillium comfort
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

• To decrease bacteria on the skin. • Recommended for repeated use.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 85 % v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• To decrease bacteria on the skin.

• Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

OTC - DO NOT USE SECTION

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

In case of contact, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hands thoroughly with product and allow to dry without wiping

• Supervise children in the use of this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C 10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, isopropyl alcohol, myristyl alcohol, PVP, tetrahydroxypropyl ethylenediamine, water

PACKAGE LABEL.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

container labelfgelcontainer labelfgel

container labelBgelcontainer labelBgel

case label4case label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041851ethanol 85 % Topical GelPSN2
1041851ethanol 0.85 ML/ML Topical GelSCD2
1041851ethanol 85 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-134031678087433GTIN-13: 4031678087433
EAN-13: 4031678087433
GTIN storage (14 digits): 04031678087433		case label4.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-010-07Sterillium comfort1000 mL in 1 BOTTLE, PUMPGEL10002
65616-010-09Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-17Sterillium comfort4 in 1 CARTONGEL42
65616-010-17Sterillium comfort1000 mL in 1 BOTTLE, PUMPGEL10002
65616-010-18Sterillium comfort1000 mL in 1 BOTTLE, PUMPGEL10002
65616-010-18Sterillium comfort8 in 1 CARTONGEL82
65616-010-20Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-20Sterillium comfort2 in 1 CARTONGEL22
65616-010-21Sterillium comfort4 in 1 CARTONGEL42
65616-010-21Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-22Sterillium comfort475 mL in 1 BOTTLE, PUMPGEL4752
65616-010-22Sterillium comfort8 in 1 CARTONGEL82

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65616-01065616-010-09, 65616-010-20, 65616-010-21, 65616-010-22, 65616-010-07, 65616-010-17, 65616-010-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
MYRISTYL ALCOHOLV42034O9PUIACT
CYCLOMETHICONENMQ347994ZIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
EDETOLQ4R969U9FRIACT
POVIDONE K90RDH86HJV5ZIACT
WATER059QF0KO0RIACT
ISOHEXADECANE918X1OUF1EIACT
LEVOMENOL24WE03BX2TIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterillium comfortALCOHOLBODE Chemie GmbH2d48dab8-f70a-a2b5-e063-6294a90a14562026-03-16WarningsExact identifier
ndc (package): 65616-010-21
ndc (package): 65616-010-17
ndc (package): 65616-010-09
ndc (package): 65616-010-18
ndc (package): 65616-010-20
ndc (package): 65616-010-22
ndc (package): 65616-010-07
ndc (product): 65616-010
ndc11 (package): 65616001022
ndc11 (package): 65616001009
ndc11 (package): 65616001021
ndc11 (package): 65616001018
ndc11 (package): 65616001020
ndc11 (package): 65616001017
ndc11 (package): 65616001007
spl id: 4cc0e8b6-8640-d9a6-e063-6294a90a9caf
spl set id: 2d48dab8-f70a-a2b5-e063-6294a90a1456

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.