FDA.reportPublic FDA data

Sterillium rub fragrance-free

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 rub fragrance-free
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

• surgical hand antiseptic • significantly reduces the number of microorganisms 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 spead 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...

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 microorganisms 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 spead 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

Sterillium

rub

fragrance-free

PROCEDURAL RUB

Surgical hand rub

Fast-acting. Dermatologically tested.

Gentle to skin.

Hand Antiseptic Rub

85% w/w ethyl alcohol with moisturizers

Surgical hand antiseptic. Significantly reduces

the number of microorganisms on the hands

and forearms prior to surgery or patient care.

Read drug facts panel before use.

Designed in Germany. Made in USA.

Lot:

Use by:

BODE

NDC 65616-011-03

500 mL 16.91 fl. oz

container labelFPcontainer labelFP

container labelBPcontainer labelBP

carton labelcarton label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-134031678087686GTIN-13: 4031678087686
EAN-13: 4031678087686
GTIN storage (14 digits): 04031678087686		carton label.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
65616-011-03Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-06Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-07Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-11Sterillium rub fragrance-free2 in 1 CARTONLIQUID22
65616-011-11Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-12Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-12Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-13Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-13Sterillium rub fragrance-free8 in 1 CARTONLIQUID82
65616-011-14Sterillium rub fragrance-free2 in 1 CARTONLIQUID22
65616-011-14Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-15Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-15Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-17Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-17Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-18Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-18Sterillium rub fragrance-free8 in 1 CARTONLIQUID82

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
65616-01165616-011-11, 65616-011-12, 65616-011-13, 65616-011-14, 65616-011-15, 65616-011-03, 65616-011-06, 65616-011-07, 65616-011-17, 65616-011-18

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
MYRISTYL ALCOHOLV42034O9PUIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
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 rub fragrance-freeALCOHOLBODE Chemie GmbH2bc46854-fe65-782b-e063-6294a90a79af2026-03-16WarningsExact identifier
ndc (package): 65616-011-11
ndc (package): 65616-011-03
ndc (package): 65616-011-13
ndc (package): 65616-011-12
ndc (package): 65616-011-17
ndc (package): 65616-011-07
ndc (package): 65616-011-18
ndc (package): 65616-011-06
ndc (package): 65616-011-15
ndc (package): 65616-011-14
ndc (product): 65616-011
ndc11 (package): 65616001107
ndc11 (package): 65616001117
ndc11 (package): 65616001111
ndc11 (package): 65616001103
ndc11 (package): 65616001113
ndc11 (package): 65616001114
ndc11 (package): 65616001115
ndc11 (package): 65616001112
ndc11 (package): 65616001118
ndc11 (package): 65616001106
spl id: 4d2a8460-ac82-4556-e063-6294a90a5f34
spl set id: 2bc46854-fe65-782b-e063-6294a90a79af

Reported adverse events (FAERS/openFDA)#

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