Active Ingredient
Ethyl Alcohol 85% w/w
Sterillium Rub Fragrance-free Liquid
FDA Label NDC 65616-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bode Chemie Gmbh for the product Sterillium Rub Fragrance-free (NDC 65616-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
• surgical hand antiseptic
• significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
Warnings
For external use only.
Flammable, keep away from fire or flame.
Otc - Do Not Use
Do not use in or near the eyes or on mucous membranes.
Otc - When Using
When using this product avoid contact with eyes. In case of contact with eyes, flush immediately with water.
Otc - Stop Use
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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• 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
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
* Please review the disclaimer below.
