Label: INOFOAM ANTIBACTERIAL FOAMING HAND WASH- chloroxylenol liquid

  • NDC Code(s): 58575-516-01, 58575-516-11, 58575-516-18, 58575-516-42
  • Packager: Inopak, Ltd
  • 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 February 19, 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 and redness develop or if condtion 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.
    • Rince under running water and dry thoroughly.
  • INACTIVE INGREDIENT

    Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, Phenoxyethanol, Isopropyl Alcohol, Fragrance, Citric Acid, FD&C Red No. 4

  • SPL UNCLASSIFIED SECTION

    Inopak, LTD.

    Ringwood, NJ 07456

    1-800-767-7725 • www.inopak.com

  • PRINCIPAL DISPLAY PANEL

    INOFOAM

    Antibacterial Foaming Hand Wash

    With 0.3% Chloroxylenol

    33.8 fl. oz. (1000 mL)

    Inofoam Foam HW 1000mL 58575-516

  • INGREDIENTS AND APPEARANCE
    INOFOAM ANTIBACTERIAL  FOAMING HAND WASH
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-516
    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:58575-516-011000 mL in 1 POUCH; Type 0: Not a Combination Product02/15/202101/20/2024
    2NDC:58575-516-18540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/15/202105/19/2024
    3NDC:58575-516-423785 mL in 1 JUG; Type 0: Not a Combination Product02/15/202101/20/2024
    4NDC:58575-516-111000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product02/15/202105/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/15/202105/19/2024
    Labeler - Inopak, Ltd (194718243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inopak, Ltd194718243manufacture(58575-516)
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