Label: DERMA CIDOL 2000- chloroxylenol 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 February 18, 2015

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  • Active Ingredient:

    0.5% Chloroxylenol

  • Purpose

    Healthcare Personnel Handwash

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Use decreases the level of transient microorganisms on the skin before contact with patients under medical care or treatment.

  • Warning For external use only

    Stop use and ask a doctor if irritation and redness develop and persist for more than 5 days.

    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.

  • DOSAGE & ADMINISTRATION

    Directions: Wet hands with water and add a small amount of Derma Cidol 2000. Vigorously rub together all surfaces of lathered hands for at least 10 seconds. Thoroughly rinse under a stream of water. Repeat as necessary between patients.

    For Professional Use Only

  • INACTIVE INGREDIENT

    Inactive Ingredients: Cocamidopropyl Betaine, Cocoline Brown, Diazolidinyl urea, Disodium EDTA, Disodium Laureth Sulfosuccinate, FD&C Red 40, Fragrance, PEG-150, Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Triglycerides, Polysorbate 20, Propylene Glycol, Purified Water USP, Sodium Laureth Sulfate, Sodium Lauryl Sulfoacetate

  • Packaging

    Derma Cidol

  • INGREDIENTS AND APPEARANCE
    DERMA CIDOL 2000 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10802-8081
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    PENTAERYTHRITYL TETRASTEARATE (UNII: W9Q3DZS0EG)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10802-8081-7355 mL in 1 CONTAINER
    2NDC:10802-8081-93790 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/18/2015
    Labeler - Rosedale Therapeutics, LLC (161264622)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei LLC105803274manufacture(10802-8081)
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