Label: FIRST STREET ANTIMICROBIAL HAND WASH- chloroxylenol soap

  • NDC Code(s): 61504-501-01, 61504-501-16, 61504-501-64
  • Packager: Amerifoods Trading Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 12, 2024

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  • Active Ingredient

    Chloroxylenol 0.3% 

  • Inactive Ingredients

    2-Methyl-4-Isothiazolin-3-One, 5-Chloro-2Methyl-4-Isothizolin-3-One, Cocamide MIPA, Cocamidopropyl Betaine, FD&C Red No.40, FD&C Yellow No. 5, Fragrance, Glycerin, Sodium Chloride, Sodium Laurel Sulfate, Water

  • Purpose

    Antimicrobial

  • Uses

    • For hand washing to decrease bacteria on the skin
    • recommended for repeated use
  • Warning

    • For external use only
    • Do not use in or near eyes

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Wet hands and forearms
    • Apply 5 milliliters (teaspoonful or palmful) to hands and forarms
    • Scrub thoroughly for 15 seconds
  • First Street Liquid Antimicrobial Hand Soap

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST STREET ANTIMICROBIAL HAND WASH 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61504-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61504-501-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2023
    2NDC:61504-501-641893 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2023
    3NDC:61504-501-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/29/202307/15/2024
    Labeler - Amerifoods Trading Company (626388680)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(61504-501) , api manufacture(61504-501) , pack(61504-501)
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