Active Ingredient
Ethyl Alcohol 85 % v/v
Sterillium Comfort Gel
FDA Label NDC 65616-010
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 Comfort (NDC 65616-010). 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 - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
• To decrease bacteria on the skin.
• Recommended for repeated use.
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.
In case of contact, rinse thoroughly 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
• Wet hands thoroughly with product and allow to dry without wiping
• Supervise children in the use of this product
Inactive Ingredients
acrylates/C 10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, isopropyl alcohol, myristyl alcohol, PVP, tetrahydroxypropyl ethylenediamine, water
Package Label.Principal Display Panel
Sterillium
comfort gel
Healthcare personnel Hand Rub
Kills > 99.999% of germs
in 15 seconds without water.
Boosts skin moisture level.
Leaves hands feeling soft and healthy.
Dermatologically tested.
Hand Antiseptic Gel
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 65616-010-09
475 mL 16.06 fl. oz
* Please review the disclaimer below.
