Label: STERILLIUM FOAM- alcohol liquid

  • NDC Code(s): 65616-006-03, 65616-006-06, 65616-006-11, 65616-006-12, view more
    65616-006-13, 65616-006-14, 65616-006-15, 65616-006-16
  • Packager: BODE Chemie GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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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

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

    In case of contact, rinse thoughly with water.

  • STOP USE

    Stop use and ask a doctor if

    • irritation and redness develop
    • conditions 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

    • Apply to clean, dry hands, covering entire surface, including nails
    • Rub until dry
    • Supervise children in the use of this product
  • Inactive ingredients

    Bis-PEG/PPG-20/20 Dimethicone, Cyclomethicone, Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water.

  • PRINCIPAL DISPLAY PANEL

    Sterillium

    foam

    Healthcare Personnel Hand Antiseptic

    Kills > 99.999% of germs

    in 15 seconds without water.

    Dermatologically tested. Fragrance Free

    Hand Antiseptic Foam

    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 65616-006-03 500 mL 16.91 fl. oz

    container labelcontainer label

  • INGREDIENTS AND APPEARANCE
    STERILLIUM FOAM 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65616-006
    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
    BIS-PEG/PPG-20/20 DIMETHICONE (UNII: 05W209DSBS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65616-006-03500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/25/2019
    2NDC:65616-006-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/25/2019
    3NDC:65616-006-112 in 1 CARTON12/11/2024
    3500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:65616-006-124 in 1 CARTON12/11/2024
    44 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:65616-006-138 in 1 CARTON12/11/2024
    5500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    6NDC:65616-006-142 in 1 CARTON12/11/2024
    61000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    7NDC:65616-006-154 in 1 CARTON12/11/2024
    71000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    8NDC:65616-006-168 in 1 CARTON12/11/2024
    81000 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)09/25/2019
    Labeler - BODE Chemie GmbH (316039007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(65616-006)
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