FDA.reportPublic FDA data

Sterillium Rub Fragrance Free

Manufacturer
BODE Chemie GmbH | Kutol Products Company
Effective date
2025-04-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:59:09

Label at a glance#

ProductSterillium Rub Fragrance Free
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

surgical hand antiseptic significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

Dosage and administration

apply to clean, dry hands for the first use of the day, use a nail pick dispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles repeat procedure with other hand with hands still moist spread around the hand and lower 1/3 of the forearm reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces following ...

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

  • surgical hand antiseptic
  • significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

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.

OTC - WHEN USING SECTION

When using this productavoid contact with eyes. In case of contact with eyes, flush immediately 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

  • apply to clean, dry hands
  • for the first use of the day, use a nail pick
  • dispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles
  • repeat procedure with other hand
  • with hands still moist spread around the hand and lower 1/3 of the forearm
  • reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces
  • following application, rub hands until dry
  • hands should remain moist for entire application time, approx. 1.5 minutes.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, isopropyl alcohol,myristyl alcohol, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BODE

Sterillium Rub

Fragrance-Free

Procedural Rub

SURGICAL HAND RUB

85% w/w ethyl alcohol with emollients

Indication: Significantly reduces the number

of micro-organisms on the hands and forearms

prior to surgery or patient care.

Fast-actng. Dermatologically tested.

Gentle to skin.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-008-06

1000 mL 33.8 fl.oz.

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-008-06Sterillium Rub Fragrance Free1000 mL in 1 BOTTLE, PUMPLIQUID10006
65616-008-07Sterillium Rub Fragrance Free1000 mL in 1 BOTTLE, PUMPLIQUID10006
65616-008-08Sterillium Rub Fragrance Free50 mL in 1 BOTTLE, SPRAYLIQUID506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-008STERILLIUM RUB FRAGRANCE FREE (ALCOHOL) LIQUID [BODE CHEMIE GMBH]6Current NDC, Legacy NDC, 3 package rows20250416_8e73359b-af12-955c-e053-2a95a90a76b6.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
65616-00865616-008-06, 65616-008-08, 65616-008-07

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
MYRISTYL ALCOHOLV42034O9PUIACT
GLYCERINPDC6A3C0OXIACT
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 Rub Fragrance FreeALCOHOLBODE Chemie GmbH8e73359b-af12-955c-e053-2a95a90a76b62025-04-14WarningsExact identifier
ndc (package): 65616-008-08
ndc (package): 65616-008-07
ndc (package): 65616-008-06
ndc (product): 65616-008
ndc11 (package): 65616000808
ndc11 (package): 65616000806
ndc11 (package): 65616000807
spl id: 32be39e9-0c20-1413-e063-6394a90a1dea
spl set id: 8e73359b-af12-955c-e053-2a95a90a76b6

Reported adverse events (FAERS/openFDA)#

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