Label: SUNDROPS 67- chloroxylenol soap

  • NDC Code(s): 63621-353-65, 63621-353-80
  • Packager: Sunburst Chemicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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  • Active Ingredient

    Chloroxylenol 0.75% 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 six 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, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1

  • PRINCIPAL DISPLAY PANEL

    Case Label - 8 x 1000 mL Bags

  • INGREDIENTS AND APPEARANCE
    SUNDROPS 67 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63621-353
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Colorgreen (green, dispensed as white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63621-353-658 in 1 BOX05/08/200806/30/2024
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:63621-353-806 in 1 BOX02/14/200803/18/2020
    2500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/14/200806/30/2024
    Labeler - Sunburst Chemicals, Inc. (006159339)
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