Label: KLEAN-HANDS liquid

  • 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 March 14, 2021

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  • COMPONENTS

    Chloroxylenol 0.3%

  • PURPOSE

    Antimicrobial Hand Soap

  • INDICATIONS & USAGE

    Handwash to help decrease bacteria on the skin. Recommended for repeated use

  • WARNINGS

    For external use only

  • DO NOT USE

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts

  • 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.

  • DOSAGE & ADMINISTRATION

    Wet hands
    Apply a small amount of product and work into a lather
    Rinse well and dry hands completely

  • ACTIVE INGREDIENT

    Chloroxylenol 0.3%

  • INACTIVE INGREDIENT

    Dodecylbenzene sulfonic acid, triethanolamine salt, Cocoamidopropyl betaine, Glycerol, 1,3-propanediol, Ammonium lauryl sulfate, Coconut monoethanolamide, Sodium Chloride, Fragrance, Dye, Water

  • Label

    Klean-Hands Antimicrobial Hand soap

    Formulated for food service and health care professionals who wash hands frequently and require the protection of an antimicrobial soap.

    FDA registered

    Made in USA

    * Utilize the quickacting antimicrobial agent (PCMX) to kill germs

    * Pleasing agent

    * Powerful degreasers

    * Soothing to the skin

    * Ideal schools, health clubs, offices and recreation areas

    * Rich Lather

    * High foam enhances cleaning

    * Performs equally well in hand and soft water

    * Conditions as it cleans

    Sold by: Rite-Kem Inc., 703 Westmoreland Drive, Tupelco, MS 38801

    Ph.: 662-840-6060

    NDC: 73943-948-xx

    Klean Hands 55G

    Klean Hands 5G

    Klean Hands

    Klean Hands 128oz

    Klean Hands 8oz

  • INGREDIENTS AND APPEARANCE
    KLEAN-HANDS 
    klean-hands liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73943-948
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73943-948-01354 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    2NDC:73943-948-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    3NDC:73943-948-0318927 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    4NDC:73943-948-04208198 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    5NDC:73943-948-05236 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Labeler - Rite-Kem Incorporated (786892927)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rite-Kem Incorporated786892927manufacture(73943-948)
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