Label: INODERM STYLE ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58575-523-07, 58575-523-10, 58575-523-17, 58575-523-42, view more
    58575-523-80, 58575-523-82
  • 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

    • For handwashing to help reduce bacteria on the skin.
    • Recommended for repeat use.
  • WARNINGS

    Warnings

    For external use only.

    When using this product, keep away from 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.
    • Lather vigorously for at least 15 seconds.
    • Rinse with water and dry thoroughly.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, DMDM Hydantoin, Alcohol, Fragrance, Isopropyl Alcohol, Citric Acid, FD&C Yellow 5, FD&C Red 4.

  • SPL UNCLASSIFIED SECTION

    Inopak, LTD.

    Ringwood, NJ 07456

    1-800-762-7725 • www.inopak.com

  • PRINCIPAL DISPLAY PANEL

    INODERM®

    With Moisturizers

    Style

    Contains Chloroxylenol 0.3%

    Liquid Antibacterial Soap

    18 fl. oz. (532 mL)

    InoDerm Style Soap 18oz 2021

  • INGREDIENTS AND APPEARANCE
    INODERM STYLE ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-523
    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)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58575-523-423800 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/202107/22/2024
    2NDC:58575-523-07237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/202110/08/2023
    3NDC:58575-523-17532 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/202107/19/2024
    4NDC:58575-523-801 in 1 BOX04/20/202101/28/2024
    4800 mL in 1 POUCH; Type 0: Not a Combination Product
    5NDC:58575-523-822000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/20/202104/21/2024
    6NDC:58575-523-101000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/20/202111/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/20/202107/22/2024
    Labeler - Inopak, Ltd (194718243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inopak, Ltd194718243manufacture(58575-523)
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