STERILLIUM MED- 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

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

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

In case of contact, rinse thoroughly with water.

Stop use and ask a dotor 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, covering entire surface, including nails

Rub until dry

Supervise children in the use of this product

Inactive Ingredients

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

Bode

Sterillium Med

Healthcare Personnel

Hand Antiseptic

85% w/w ethyl alcohol with moisturizers

Kills >99.999% of germs

in 15 seconds without water.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Read Drug Facts panel before use.

Liquid formula with

95% natural ingredients

Lot:

Use by:

Questions? Call 1-800-MEDLINE

500 ml 16.91 fl. oz.

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STERILLIUM MED 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65616-005
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
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL ETHYL KETONE (UNII: 6PT9KLV9IO)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
PROPYL ALCOHOL (UNII: 96F264O9SV)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65616-005-02500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/26/2012
2NDC:65616-005-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/26/2012
3NDC:65616-005-0850 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/26/2012
4NDC:65616-005-03500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/08/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/26/201201/01/2021
Labeler - BODE Chemie GmbH (316039007)
Establishment
NameAddressID/FEIBusiness Operations
BODE Chemie GmbH316039007manufacture(65616-005)

Revised: 9/2019
Document Id: 936ae631-c17b-8ee5-e053-2995a90a2163
Set id: 7e6828d7-771b-4bed-a161-71cdf794367e
Version: 9
Effective Time: 20190925
 
BODE Chemie GmbH