Label: PURESAN ANTIBACTERIAL FOAMING HAND WASH- chloroxylenol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Chloroxylenol 0.3% w/w

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.
  • WARNINGS

    Warnings

    For external use only.

    When using this product Keep out of eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 seconds.
    • Rinse under running water and dry thoroughly.
  • INACTIVE INGREDIENT

    Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, Phenoxyethanol, Isopropyl Alcohol, Fragrance, FD&C Red 4

  • SPL UNCLASSIFIED SECTION

    Distributed By: Puresan

    24 Ames Blvd., Hamburg, NJ 07419

    855.500.8080 • puresanusa.com

  • PRINCIPAL DISPLAY PANEL

    Antibacterial

    Foaming Hand Wash

    0.3% Chloroxylenol

    33.8 fl. oz. (1000 mL) Refill Bag FOAM

    73062-511 Foam Handwash

  • INGREDIENTS AND APPEARANCE
    PURESAN ANTIBACTERIAL FOAMING HAND WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73062-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73062-511-011000 mL in 1 BAG; Type 0: Not a Combination Product08/20/202107/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/20/202107/20/2024
    Labeler - Avro Enterprises LLC (804030166)
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