Label: CHAMPION ULTRA CLEAN- chloroxylenol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 5, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Chloroxylenol.......0.3%

  • Purpose

    Antiseptic

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

  • When Using this Product

    Avoid contact with the eyes.

    In case of eye contact, flush eyes with water.

    Do not ingest.

  • Keep out of reach of children.

    If swallowed, get medical help

    or contact a Posion Control Center immediately.

  • Directions

    -Apply to wet hands.

    -Work into a lather and  rinse thoroughly.

    -Children under 6 years of age should be supervised when using this product.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, FD&C Red #40, FD&C Yellow #5, Fragrance, Glycerin, Magnesium Nitrate, Maltodextrin, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Sodium Laureth Sulfate, Water

  • Champion Ultra-Clean Antibacterial Liquid Hand Soap

    image description
  • INGREDIENTS AND APPEARANCE
    CHAMPION ULTRA CLEAN 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77617-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL.3 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77617-017-021 in 1 BOX02/06/2020
    1NDC:77617-017-013.8919 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/06/2020
    Labeler - Maintex (008317307)
    Registrant - Maintex (008317307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc.028311595manufacture(77617-017) , api manufacture(77617-017) , pack(77617-017)