Label: MAXIM FDF- chloroxylenol soap

  • NDC Code(s): 70542-201-41, 70542-201-55
  • Packager: Midlab Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 23, 2024

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  • Active Ingredient

    Chloroxylenol 0.1%

  • Purpose

    Antiseptic

  • Uses

    • Handwash to help decrease bacteria on the skin.

  • Warnings

    For external use only.
    Do not use     in the eyes. In case of contact, immediately flush eyes with water.

  • ASK DOCTOR

    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.

  • Directions

    • Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly.
    • Children under 6 years of age should be supervised when using this product.

  • Inactive Ingredients

    Water (Aqua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (68439-57-6), Glycerin (56-81-5), Cocamidopropyl Hydroxysultaine (68139-30-0), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium Polyitaconate (26099-89-8), Dibromocyanoacetamide (10222-01-2), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4).

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    MAXIM FDF 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70542-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    DIBROMOCYANOACETAMIDE (UNII: 7N51QGL6MJ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYITACONATE (2800 MW, PHOSPHATE TERMINATED) (UNII: G7SW5QN7TT)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70542-201-413.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2019
    2NDC:70542-201-55208 L in 1 DRUM; Type 0: Not a Combination Product05/18/202103/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/11/2019
    Labeler - Midlab Incorporated (047371463)
    Registrant - Midlab Incorporated (047371463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Midlab Incorporated047371463manufacture(70542-201)
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