STERILLIUM RUB FRAGRANCE FREE- alcohol liquid 
BODE Chemie GmbH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Ethyl Alcohol 85% w/w

Purpose

Antiseptic

Uses

surgical hand antiseptic

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

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use in or near the eyes or on mucous membranes.

When using this product and contact with the eyes occurs, flush immediately with water.

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

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 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

Water, n-Propyl Alcohol, Myristyl Alcohol, Methylethylketone, Glycerin.


Bode

Sterillium Rub

Fragrance-Free

Procedural Scrub

Surgical

Hand Antiseptic

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-acting. Dermatologically tested.

Gentle to skin.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-004-06

1000 ml 33.8 fl. oz.

container label

STERILLIUM RUB FRAGRANCE FREE 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65616-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYL ALCOHOL (UNII: 96F264O9SV)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
METHYL ETHYL KETONE (UNII: 6PT9KLV9IO)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65616-004-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/28/2012
2NDC:65616-004-0850 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/28/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/28/201204/01/2021
Labeler - BODE Chemie GmbH (316039007)
Establishment
NameAddressID/FEIBusiness Operations
BODE Chemie GmbH316039007manufacture(65616-004)

Revised: 9/2019
 
BODE Chemie GmbH