Label: PRESTIGE- chloroxylenol soap

  • NDC Code(s): 63621-335-14
  • Packager: Sunburst Chemicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 21, 2024

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  • Active Ingredient

    Chloroxylenol 1% w/w

  • Purpose

    Skin Antimicrobial

  • Use

    reduces amount of bacteria on hands

  • Warnings

    For external use only. Do not use in eyes.

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician.

    Not for use on children under 6 months of age.

    For institutional and professional use only.

  • Directions

    • Wet hands and forearms.
    • Apply a small amount (5 mL) or palmful to hands and forearms.
    • Scrub thoroughly for at least fifteen seconds.
    • Rinse completely and dry.
  • Inactive Ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Product Label - 1 Gallon ShortNeck Bottle

  • INGREDIENTS AND APPEARANCE
    PRESTIGE 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63621-335
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Product Characteristics
    Colorwhite (white, opaque liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63621-335-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/03/2020
    Labeler - Sunburst Chemicals, Inc. (006159339)
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