FDA.reportPublic FDA data

Sterillium Comfort Gel NDC 65616-009

Manufacturer
BODE Chemie GmbH | Kutol Products Company
Effective date
2025-04-30
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:00:10

Label at a glance#

ProductSterillium Comfort
Active ingredientALCOHOL
Label structure11 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.

Directions

RECENT MAJOR CHANGES SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 label2FSCG_HPHR_06container label2FSCG_HPHR_06

container labelBrev.jpgcontainer labelBrev.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041851ethanol 85 % Topical GelPSN8
1041851ethanol 0.85 ML/ML Topical GelSCD8
1041851ethanol 85 % Topical GelSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-009-06Sterillium Comfort1000 mL in 1 BOTTLE, PUMPGEL10008
65616-009-07Sterillium Comfort1000 mL in 1 BOTTLE, PUMPGEL10008
65616-009-09Sterillium Comfort475 mL in 1 BOTTLE, PUMPGEL4758
65616-009-10Sterillium Comfort50 mL in 1 BOTTLE, PLASTICGEL508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-009STERILLIUM COMFORT (ALCOHOL) GEL [BODE CHEMIE GMBH]8Current NDC, Legacy NDC, 4 package rows20250502_8efc9f4e-3b20-60ba-e053-2995a90af8b1.zip

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
65616-00965616-009-10, 65616-009-09, 65616-009-06, 65616-009-07

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
CYCLOMETHICONENMQ347994ZIACT
WATER059QF0KO0RIACT
LEVOMENOL24WE03BX2TIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
ISOPROPYL ALCOHOLND2M416302IACT
POVIDONE K90RDH86HJV5ZIACT
EDETOLQ4R969U9FRIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
MYRISTYL ALCOHOLV42034O9PUIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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 GmbH8efc9f4e-3b20-60ba-e053-2995a90af8b12025-04-30WarningsExact identifier
ndc (package): 65616-009-09
ndc (package): 65616-009-10
ndc (package): 65616-009-07
ndc (package): 65616-009-06
ndc (product): 65616-009
ndc11 (package): 65616000910
ndc11 (package): 65616000909
ndc11 (package): 65616000907
ndc11 (package): 65616000906
spl id: 3404a277-8586-6960-e063-6294a90ad27e
spl set id: 8efc9f4e-3b20-60ba-e053-2995a90af8b1

Reported adverse events (FAERS/openFDA)#

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