Label: STERILLIUM RUB FRAGRANCE FREE- alcohol liquid

  • NDC Code(s): 65616-008-06, 65616-008-08
  • Packager: BODE Chemie GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient

    Ethyl Alcohol 85% w/w

  • Purpose

    Antiseptic

  • Uses

    • surgical hand antiseptic
    • significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
  • 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.

  • WHEN USING

    When using this productavoid contact with eyes. In case of contact with eyes, flush immediately 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

    • apply to clean, dry hands
    • for the first use of the day, use a nail pick
    • dispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles
    • repeat procedure with other hand
    • with hands still moist spread around the hand and lower 1/3 of the forearm
    • reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces
    • following application, rub hands until dry
    • hands should remain moist for entire application time, approx. 1.5 minutes.
  • Inactive ingredients

    glycerin, isopropyl alcohol,myristyl alcohol, water

  • PRINCIPAL DISPLAY PANEL

    BODE

    Sterillium Rub

    Fragrance-Free

    Procedural Rub

    SURGICAL HAND RUB

    85% w/w ethyl alcohol with emollients

    Indication: Significantly reduces the number

    of micro-organisms on the hands and forearms

    prior to surgery or patient care.

    Fast-actng. Dermatologically tested.

    Gentle to skin.

    Read Drug Facts panel before use.

    Lot:

    Use by:

    Questions? Call 1-800-MEDLINE

    NDC 65616-008-06

    1000 mL 33.8 fl.oz.

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  • INGREDIENTS AND APPEARANCE
    STERILLIUM RUB FRAGRANCE FREE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65616-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL89.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65616-008-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2019
    2NDC:65616-008-0850 mL in 1 BOTTLE, SPRAY; 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(65616-008)