Label: DERMAKLEEN- antimicrobial drug product soap

  • 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 January 13, 2022

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  • Active Ingredient:

    Chloroxylenol 0.2%

  • Purpose:

    Antimicrobial

  • Uses:

    For handwashing to decrease bacteria on the skin.

  • Warnings

    • For external use only.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Stop use and ask a doctor if irritation or redness develops.

  • Warnings

    • Keep out of children's reach except under adult supervision. In case of accidental ingestion contact a physician or Poison Control Center rightaway.
  • Directions:

    • Dispense into hands, wet as needed.
    • Lather vigorously for at least 15 seconds
    • Wash skin, rinse thoroughly and dry.
  • Inactive Ingredients:

    Cocamide MEA, Cocamidoproplyl Betaine, Citric Acid, DMDM Hydantoin, D&C Green#6, Fragrance, Glycerin, Methylchloroisothiazolinone, Methylparaben, Methylisothiazolinone, Propylene Glycol, Propylparaben, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Tocopheryl Acetate, Water.

  • Questions?

    Call 1-800-337-6296

  • Dermakleen Package Label Principal Display Panel

    DermaKleen

  • INGREDIENTS AND APPEARANCE
    DERMAKLEEN 
    antimicrobial drug product soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.002 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-092-08222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/15/2012
    2NDC:61924-092-013800 mL in 1 JUG; Type 0: Not a Combination Product06/01/2012
    3NDC:61924-092-341000 mL in 1 BAG; Type 0: Not a Combination Product06/01/2012
    4NDC:61924-092-27800 mL in 1 BAG; Type 0: Not a Combination Product06/01/2012
    5NDC:61924-092-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2012
    Labeler - Dermarite Industries LLC (883925562)
    Registrant - DermaRite Industries, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermarite Industries LLC883925562manufacture(61924-092)
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