Label: HAND ANTIBACTERIAL- chloroxylenol soap

  • 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 October 20, 2021

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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.25%

    Purpose

    Antibacterial

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if

    • irritation and redness develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • pump into hands, wet as needed
    • lather vigorously for at leat 15 seconds
    • wash skin, rinse and dry thoroughly
  • Inactive Ingredients:

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, Sodium Chloride, Glycerin, Disodium EDTA, PEG-150 Distearate, Citric Acid, Fragrance (Parfum), Methylisothiazolinone, Methylchloroisothiazolinone, FD&C Yellow No. 5, FD&C Red No. 4.

  • Package Labeling:

    Package Label 500mLPackage Label 710mL

  • INGREDIENTS AND APPEARANCE
    HAND ANTIBACTERIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-540-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2016
    2NDC:50302-540-01710 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/20/2016
    Labeler - PANROSA ENTERPRISES, INC. (859957578)
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