Sterillium Comfort

Dosage form: gel
Ingredients: Alcohol 85mL in 100mL
Labeler: Bode Chemie Hamburg
NDC Code: 65616-003

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.

Drug Facts

Active Ingredient                       

Ethanol 85% w/w

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 doctor if

irritation and redness develop

condition persists for more than 72 hours

Keep out or 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

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Cyclomethicone, Glycerin, Isohexadecane, Myristyl Alcohol, PVP, Tetrahydroxypropyl Ethylenediamine, Water

Sterillium Comfort Gel

Health Care Personnel Hand Antiseptic

85% w/w ethyl alcohol with moisturizers

Kills 99.999% of germs in 15 seconds without water.

Boosts skin moisture level.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

1000ml 33.8 fl. oz


Purpose

Antiseptic

STERILLIUM COMFORT  
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65616-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (Alcohol) Alcohol85 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 
Glycerin 
Myristyl Alcohol 
Water 
Packaging
#Item CodePackage Description
1NDC:65616-003-01100 mL in 1 BOTTLE, PLASTIC
2NDC:65616-003-09475 mL in 1 BOTTLE, PUMP
3NDC:65616-003-071000 mL in 1 BOTTLE, PUMP
4NDC:65616-003-1050 mL in 1 BOTTLE, PLASTIC
5NDC:65616-003-112.4 mL in 1 POUCH
6NDC:65616-003-051000 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2007
Labeler - Bode Chemie Hamburg (316039007)
Establishment
NameAddressID/FEIOperations
Bode Chemie Hamburg316039007manufacture(65616-003)
Establishment
NameAddressID/FEIOperations
Chester Packaging, LLC004237806repack(65616-003)

Revised: 06/2013
 
Bode Chemie Hamburg

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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