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
  • 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 16, 2017

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  • Active ingredient

    Chloroxylenol 0.5%

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  • Purpose

    Antimicrobial

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  • Use

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

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  • Directions

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

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  • INGREDIENTS AND APPEARANCE
    MICRELL ANTIBACTERIAL FOAM HANDWASH  
    chloroxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-095
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.005 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21749-095-22 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/23/2006
    2 NDC:21749-095-53 535 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 06/23/2006
    3 NDC:21749-095-97 700 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/23/2006
    4 NDC:21749-095-89 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/23/2006
    5 NDC:21749-095-90 1250 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/23/2006
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 06/23/2006
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    Name Address ID/FEI Business Operations
    GOJO Industries, Inc. 036424534 manufacture(21749-095)
    Establishment
    Name Address ID/FEI Business Operations
    GOJO Industries, Inc. 088312414 label(21749-095) , pack(21749-095)
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