FDA.reportPublic FDA data

Sterillium Med

Manufacturer
BODE Chemie GmbH | Kutol Products Company
Effective date
2025-04-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:00:10

Label at a glance#

ProductSterillium Med
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

For handwashing 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% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing 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

Glycerin, Isopropyl Alcohol, Myristyl Alcohol, 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 Med

HEALTHCARE

PERSONNEL HAND RUB

85% w/w ethyl alcohol with moisturizers

Kills> 99.999% of germs in 15 seconds without water.

Leaves hands feeling soft and healthy.

Dermatologically Tested.

Read Drug Facts panel before use.

Liquid formula with

95% natural ingredients

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65615--007-06

1000 mL 33.8 fl. oz.

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-007-03Sterillium Med500 mL in 1 BOTTLE, PUMPLIQUID5006
65616-007-06Sterillium Med1000 mL in 1 BOTTLE, PUMPLIQUID10006
65616-007-07Sterillium Med1000 mL in 1 BOTTLE, PUMPLIQUID10006
65616-007-08Sterillium Med50 mL in 1 BOTTLE, SPRAYLIQUID506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-007STERILLIUM MED (ALCOHOL) LIQUID [BODE CHEMIE GMBH]6Current NDC, Legacy NDC, 4 package rows20250502_8d80d5fd-7869-c551-e053-2995a90af2a9.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65616-00765616-007-03, 65616-007-06, 65616-007-08, 65616-007-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
MYRISTYL ALCOHOLV42034O9PUIACT
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 MedALCOHOLBODE Chemie GmbH8d80d5fd-7869-c551-e053-2995a90af2a92025-04-30WarningsExact identifier
ndc (package): 65616-007-06
ndc (package): 65616-007-03
ndc (package): 65616-007-07
ndc (package): 65616-007-08
ndc (product): 65616-007
ndc11 (package): 65616000703
ndc11 (package): 65616000708
ndc11 (package): 65616000706
ndc11 (package): 65616000707
spl id: 34048363-5c61-6d6e-e063-6294a90aa516
spl set id: 8d80d5fd-7869-c551-e053-2995a90af2a9

Reported adverse events (FAERS/openFDA)#

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