FDA.reportPublic FDA data

Sterillium Foam

Manufacturer
BODE Chemie GmbH | Kutol Products Company
Effective date
2026-03-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:50:33

Label at a glance#

ProductSterillium Foam
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

Apply to clean, dry hands, covering entire surface, including nails Rub until dry 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 thoughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation and redness develop
  • conditions 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

  • Apply to clean, dry hands, covering entire surface, including nails
  • Rub until dry
  • Supervise children in the use of this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bis-PEG/PPG-20/20 Dimethicone, Cyclomethicone, Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water.

Uses

RECENT MAJOR CHANGES SECTION

• To decrease bacteria on the skin.

• Recommended for repeated use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sterillium

foam

Healthcare Personnel Hand Antiseptic

Kills > 99.999% of germs

in 15 seconds without water.

Dermatologically tested. Fragrance Free

Hand Antiseptic Foam

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 65616-006-03 500 mL 16.91 fl. oz

container labelcontainer label

container labelFcontainer labelF

carton 4 labelcarton 4 label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2200822ethanol 85 % Topical FoamPSN9
2200822ethanol 0.85 ML/ML Topical FoamSCD9
2200822ethanol 85 % Topical FoamSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-134031678089529GTIN-13: 4031678089529
EAN-13: 4031678089529
GTIN storage (14 digits): 04031678089529		carton 4 label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-006-03Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-06Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-07Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-11Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-11Sterillium Foam2 in 1 CARTONLIQUID29
65616-006-12Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-12Sterillium Foam4 in 1 CARTONLIQUID49
65616-006-13Sterillium Foam500 mL in 1 BOTTLE, PUMPLIQUID5009
65616-006-13Sterillium Foam8 in 1 CARTONLIQUID89
65616-006-14Sterillium Foam2 in 1 CARTONLIQUID29
65616-006-14Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-15Sterillium Foam4 in 1 CARTONLIQUID49
65616-006-15Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-16Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-16Sterillium Foam8 in 1 CARTONLIQUID89
65616-006-17Sterillium Foam4 in 1 CARTONLIQUID49
65616-006-17Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-18Sterillium Foam1000 mL in 1 BOTTLE, PUMPLIQUID10009
65616-006-18Sterillium Foam8 in 1 CARTONLIQUID89

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65616-00665616-006-03, 65616-006-06, 65616-006-11, 65616-006-12, 65616-006-13, 65616-006-14, 65616-006-15, 65616-006-16, 65616-006-17, 65616-006-18, 65616-006-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BIS-PEG/PPG-20/20 DIMETHICONE05W209DSBSIACT
ISOPROPYL ALCOHOLND2M416302IACT
MYRISTYL ALCOHOLV42034O9PUIACT
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-12-08monthly-update2026-06-03 17:45:32

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 FoamALCOHOLBODE Chemie GmbH93680cd8-609f-48f2-e053-2995a90aa3552026-03-16WarningsExact identifier
ndc (package): 65616-006-13
ndc (package): 65616-006-11
ndc (package): 65616-006-06
ndc (package): 65616-006-14
ndc (package): 65616-006-12
ndc (package): 65616-006-16
ndc (package): 65616-006-18
ndc (package): 65616-006-15
ndc (package): 65616-006-07
ndc (package): 65616-006-17
ndc (package): 65616-006-03
ndc (product): 65616-006
ndc11 (package): 65616000603
ndc11 (package): 65616000613
ndc11 (package): 65616000607
ndc11 (package): 65616000606
ndc11 (package): 65616000618
ndc11 (package): 65616000611
ndc11 (package): 65616000615
ndc11 (package): 65616000616
ndc11 (package): 65616000617
ndc11 (package): 65616000614
ndc11 (package): 65616000612
spl id: 4d2a68b7-91b6-27e1-e063-6394a90a07f7
spl set id: 93680cd8-609f-48f2-e053-2995a90aa355

Reported adverse events (FAERS/openFDA)#

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