Label: STERILLIUM COMFORT- alcohol gel

  • NDC Code(s): 65616-010-09, 65616-010-20, 65616-010-21, 65616-010-22
  • Packager: BODE Chemie GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 3, 2025

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  • Active ingredient

    Ethyl Alcohol 85 % v/v

  • 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.

    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 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

    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

    container labelfgel

    container labelBgel

    case label4

  • INGREDIENTS AND APPEARANCE
    STERILLIUM COMFORT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65616-010
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    EDETOL (UNII: Q4R969U9FR)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65616-010-09475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/03/2025
    2NDC:65616-010-202 in 1 CARTON02/03/2025
    2475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:65616-010-214 in 1 CARTON02/03/2025
    3475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:65616-010-228 in 1 CARTON02/03/2025
    4475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/03/2025
    Labeler - BODE Chemie GmbH (316039007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(65616-010)
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