Label: STERILLIUM COMFORT- alcohol gel

  • NDC Code(s): 65616-009-06, 65616-009-09, 65616-009-10
  • Packager: BODE Chemie GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

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  • Active ingredient

    Ethyl Alcohol 85% v/v

  • 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

    Do not usein or near the eyes or on mucous membranes.

    In case of contact, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
  • 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.

  • PRINCIPAL DISPLAY PANEL

    BODE

    Sterillium Comfort Gel

    HEALTHCARE

    PERSONNEL HAND RUB

    85% v/v 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

    NDC 65616-009-06

    1000 mL 33.8 fl.oz. (1QT 1.8 FL OZ)

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  • INGREDIENTS AND APPEARANCE
    STERILLIUM COMFORT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65616-009
    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
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    EDETOL (UNII: Q4R969U9FR)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65616-009-1050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201902/28/2023
    2NDC:65616-009-09475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2019
    3NDC:65616-009-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/31/2019
    Labeler - BODE Chemie GmbH (316039007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(65616-009)
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