Label: XTRA ANTIBACTERIAL HAND JUICY ORANGE- chloroxylenol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.30%

    Purpose

    Antibacterial hand soap

  • Uses

    • for handwashing, to reduce bacteria on skin
  • Warnings

    For external use only.

    Keep out of reach of children.

    Avoid contact with eyes. If eye contact occures flush thoroughly with water. Do not ingest. If ingested, drink plenty of water, contact a physician.

  • Directions

    • Apply palmful to wet hands. Scrub and rinse thoroughly.
  • Inactive Ingredients

    Deionized Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Fragrance, Sodium Hydroxide, Lactic Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C yellow no.5, FD&C red no.40

  • Questions/Comments?

    Call toll-free 1-877-879-6999 or email us at info@amgbrandsllc.com

  • Package Labeling:

    Label
  • INGREDIENTS AND APPEARANCE
    XTRA ANTIBACTERIAL HAND JUICY ORANGE 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-0033
    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 LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51628-0033-0709 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/01/2023
    Labeler - MY IMPORTS USA, LLC (195767988)
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