Label: FOAMING HAND ANTIBACTERIAL- chloroxylenol soap

  • NDC Code(s): 83019-103-11
  • Packager: Draco Hygienic Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 2, 2024

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  • ACTIVE INGREDIENT

    CHLOROXYLENOL @ 0.45%

  • PURPOSE

    ANTISEPTIC

  • USE

    HELP PREVENT CROSS CONTAMINATION BY HAND CONTACT TO REDUCE INCIDENCE ON NOSOCOMIAL INFECTION.

  • WARNINGS

    For external use only.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER.
    • AVOID CONTACT WITH BROKEN SKIN.

    STOP USE THIS PRODUCT AND ASK A DOCTOR IF

    • CONDITIONS WORSEN OR IRRITATION PERSISTS.
    • IRRITATION OR REDNESS DEVELOPS AND PERSISTED FOR MORE THAN 72 HOURS.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    lf swallowed,get medical help or contact Poison Control Center right away.

  • DIRECTIONS

    • WET HANDS AND FOREARMS.
    • APPLY A SMALL AMOUNT OF SOAP AND SCRUB THOROUGHLY FOR 1 MINUTE.
    • RINSE THOROUGHLY.
    • DRY HANDS COMPLETELY.
  • OTHER INFORMATION

    • Store below 20-25°C (60 TO 77°F)
  • INACTIVE INGREDIENTS

    Water, Sodium Laureth Sulfate, Propylene Glycol, Polyquaternium 7, Fragrance, Citric Acid, Color Dye.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FOAMING HAND  ANTIBACTERIAL
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83019-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.45 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83019-103-111000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/25/2024
    Labeler - Draco Hygienic Products Inc. (839066156)
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