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

  • 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 24, 2016

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  • Active ingredient

    Chloroxylenol (PCMX), 4% 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
  • Inactive ingredients

    Citric Acid, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Propylene Glycol, Sodium C12-15 Pareth-15 Sulfonate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Sodium Lauryl Sulfate, Soy Acid, Styrene/VP Copolymer, Water

  • Questions?

    Call 1-800-MEDLINE

  • Package Label - Box Principal Display Panel top

    NDC 53329-924-33

    Scrub-In

    REF DYND371163

    SURGICAL SCRUB BRUSH/SPONGE

    WITH NAIL CLEANER

    LATEX FREE

    • Chloroxylenol (PCMX), 4% w/w
    • Approximate Volume 12 mL
    • For Single Use Only

    QTY 30

    label

  • INGREDIENTS AND APPEARANCE
    SCRUB-IN SURGICAL SCRUB BRUSH/SPONGE 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-924
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-924-3330 in 1 BOX
    1NDC:53329-924-0912 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2012
    Labeler - Medline Industries, Inc. (025460908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medline Industries, Inc.185862984manufacture(53329-924) , analysis(53329-924)
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