Label: SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE- chloroxylenol solution

  • NDC Code(s): 53329-923-09, 53329-923-33
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated February 8, 2022

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  • Active ingredient

    Chloroxylenol (PCMX), 3.3% w/w

  • Purpose

    Surgical Hand Scrub

  • Uses

    • Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
  • Warnings

    For external use only

    Do not use

    • in the eyes

    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

    • Clean under nails with nail pick. Nails should be maintained with a 1 millimeter free edge
    • Wet hands and forearms
    • Scrub thoroughly paying particular attention to the nails, cuticles, and interdigital spaces
    • Rinse and repeat
  • Other information

    • Protect from freezing
    • Avoid excessive heat
    • Not made with Natural Rubber Latex
  • Inactive ingredients

    Citric Acid, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Soy Acid, Water

  • Questions?

    Call 1-800-MEDLINE

  • Manufacturing Information

    Manufactured by: Medline Inustries, Inc.

    THree Lakes Drive, Northfield, IL 60093 USA

    Made in the USA

    1-800-MEDLINE

    www.medline.com

    REF: DYND374081

    RB20HND

  • Package Label

    Label Box

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-923
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    AMINO ACIDS, SOY (UNII: NWB9514AZM)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-923-3330 in 1 BOX11/12/2019
    1NDC:53329-923-0920 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:53329-923-0920 mL in 1 POUCH; Type 0: Not a Combination Product11/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2012
    Labeler - Medline Industries, LP (025460908)
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