Label: SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER 3.3% PCMX- chloroxylenol sponge

  • NDC Code(s): 84128-004-01
  • Packager: Xinxiang Xinda Technology Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 27, 2024

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  • Active ingredient

    Chloroxylenol (pcmx), 3.3% w/w

  • Purpose

    Surgical Hand Scrub

  • Use

    Preoperative cleaning of healthcare personnel arms and hands.Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery.

  • Warnings

    For external use only.

    Do not use

    if redness or irritation occurs.

    When using this product

    avoid contact with eyes.

    Stop use and ask a doctor if

    severe adverse reactions occur.

    Keep out of reach of children.

    If swallowed or gets in eyes,get medical help or contact a Poison Control Center immediately.

  • Directions

    ●Wet hands, wrists and forearms to the elbows with water. Hands should be held higher than the elbows at all times

    ●Clean under nails with nail pick provided

    ●Use the brush side toclean the nails, cuticles and interdigital spaces between the fingersand the sponge side to scrub the hands and forearms. Wet sponge and squeeze to work up lather ·

    ●Scrub the nails, cuticles and interdigital spaces between the fingers, hands and forearms for 3 minutes in total . Scrub for an additional 2 minutes with using the sponge side only

    ●Rinse the hands, wrists and forearms with plenty of water

    ●Dry with a sterile towel from hands to elbows.Hold hands upwards.

  • Inactive ingredients

    Ethano, Sodium dodecyl sulfate, Sodium Alcohol Ether Sulphate, Glycerol, Ethoxylated hydrogenated castor oil, Purified Water, Hydroxyethylcellulose

  • Other information

    ● Store at 20-25° (68-77°F).
    ● Avoid overheating 40°C (104 F)
    ● Discard after single use.

  • REF 2504-01A

    20ML

  • INGREDIENTS AND APPEARANCE
    SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER 3.3% PCMX 
    chloroxylenol sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84128-004
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84128-004-0130 in 1 BOX02/27/2024
    11 in 1 BAG
    120 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/27/2024
    Labeler - Xinxiang Xinda Technology Co.,Ltd (546423962)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xinxiang Xinda Technology Co.,Ltd546423962manufacture(84128-004)
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