Label: MICRELL ANTIBACTERIAL FOAM HANDWASH- chloroxylenol liquid

  • NDC Code(s): 21749-095-22, 21749-095-53, 21749-095-89, 21749-095-90, view more
    21749-095-97
  • Packager: GOJO Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 16, 2017

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  • Active ingredient

    Chloroxylenol 0.5%

  • Purpose

    Antimicrobial

  • Use

    • Handwash to help decrease bacteria on the skin 
    • Recommended for repeated use
  • Warnings

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands. 
    • Apply product and thoroughly cover hands with lather. 
    • Rinse well and dry hands completely.
  • Inactive ingredients

    Water (Aqua), Alcohol, Lauric Acid, Ethanolamine, Dipropylene Glycol, Lactic Acid, Poloxamer 124, Isopropyl Alcohol, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Methylparaben, Propylparaben, Green 3 (CI 42053), Red 33 (CI 17200)

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    MICRELL ANTIBACTERIAL FOAM HANDWASH  
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-095-22200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
    2NDC:21749-095-53535 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/23/2006
    3NDC:21749-095-97700 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
    4NDC:21749-095-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
    5NDC:21749-095-901250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/23/2006
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534manufacture(21749-095)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.088312414label(21749-095) , pack(21749-095)
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