Label: ACUTE-KARE HEALTHCARE PERSONNEL HANDWASH- chloroxylenol soap

  • NDC Code(s): 11084-800-13, 11084-800-41
  • Packager: SC Johnson Professional USA, Inc.
  • 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 July 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Chloroxylenol 1.0%

  • Purpose

    Antiseptic

  • Uses

    • Antiseptic Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.
  • Warnings

    For external use only

    When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

    Stop use and ask a doctor if irritation and redness develop and symptoms persist for more than 3 days.

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • wet skin and spread a small amount on the hands
    • wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts
  • Inactive ingredients

    Aqua (Water), Propylene Glycol, Sodium Lauroyl Sarcosinate, PEG-150 Distearate, Disodium Cocoamphodiacetate, Polyquaternium-7, Tetrasodium EDTA, Acrylates/PEG-10 Maleate/Styrene Copolymer, Citric Acid, Parfum (Fragrance).

  • Questions or comments?

    1-866-783-0422

  • PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

    SCJ PROFESSIONAL
    HEALTHCARE

    Acute Kare®

    NDC 11084-800-41

    Hand Soap
    Antimicrobial Handwash

    Antimicrobial | Moisturising | Mild Fragrance

    1 Liter SDS (33.8 fl oz) (1.05 qt)
    SAP # 4000000051

    Manufactured for:
    SC Johnson Professional USA, Inc.
    Charlotte, NC 28217
    1-866-783-0422 www.scjp.com
    Pat. www.scjp.com/patents

    REORDER #
    1206-87

    deb
    SKIN CARE

    PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label
  • INGREDIENTS AND APPEARANCE
    ACUTE-KARE   HEALTHCARE PERSONNEL HANDWASH
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-800-13444 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/201801/01/2022
    2NDC:11084-800-411000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2018
    Labeler - SC Johnson Professional USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    STERIS Corporation 139424188MANUFACTURE(11084-800)
    Establishment
    NameAddressID/FEIBusiness Operations
    APEX International, Inc.015226132MANUFACTURE(11084-800)
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