Label: WAXIE ANTIBACTERIAL HAND- chloroxylenol soap

  • NDC Code(s): 61666-901-23, 61666-901-41
  • Packager: Waxie's Enterprises, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Active Ingredient

    Chloroxylenol 0.25%.

  • Purpose

    Antiseptic

  • Uses

    Handwash to help decrease bacteria on the skin

  • Warning:

    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 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, 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; Sodium Laureth-3 Sulfate; Coco Monoisopropanolamide; Propylene Glycol; Sodium Chloride; Sodium Lauryl Sulfate; Cocamidopropyl Betaine; Edetate Sodium; Propanediol; Fragrance; Anhydrous Citric Acid; Glycol Stearate; Methylisothiazolinone; Methylchloroisothiazolinone; Rhodamine B; Ext. D&C Violet No. 2.; Dibromocyanoacetamide.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel 16 ozPrincipal Display Panel gallon

  • INGREDIENTS AND APPEARANCE
    WAXIE ANTIBACTERIAL HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61666-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    RHODAMINE B (UNII: K7G5SCF8IL)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    DIBROMOCYANOACETAMIDE (UNII: 7N51QGL6MJ)  
    Product Characteristics
    Colorpink (Pearly) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61666-901-413.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/02/2021
    2NDC:61666-901-230.47 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/02/2021
    Labeler - Waxie's Enterprises, LLC (029142577)
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