Label: MAXIM ASSURE- pcmx, dishwashing and hand soap soap

  • NDC Code(s): 70542-701-41, 70542-701-55
  • Packager: Midlab Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    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.

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

    KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
    • Children under 6 years of age should be supervised when using this product.

    Inactive Ingredients

    Water, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Laureth-3 Sulfate, Sodium Chloride, Propylene glycol, Propanediol, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, and Red 40.

  • INGREDIENTS AND APPEARANCE
    MAXIM ASSURE 
    pcmx, dishwashing and hand soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70542-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL1 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EUGENOL (UNII: 3T8H1794QW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Colororange (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70542-701-413.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2017
    2NDC:70542-701-55208 L in 1 DRUM; Type 0: Not a Combination Product10/22/202005/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/12/2017
    Labeler - Midlab Incorporated (047371463)
    Registrant - Midlab Incorporated (047371463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Midlab Incorporated047371463manufacture(70542-701)
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