Label: AFFEX ANTIMICROBIAL FOAMING HAND SO AP- chloroxylenol liquid

  • 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 September 30, 2016

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  • Active ingredient

    Chloroxylenol 0.3%

  • Purpose

    Antimicrobial

  • Uses

    • 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 a small amount of product and work into a lather
    • Rinse well and dry hands completely
  • Inactive ingredients

    Water (Aqua), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    AFFEX ANTIMICROBIAL FOAMING HAND SO AP 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54057-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    JOJOBA OIL (UNII: 724GKU717M)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CORN OIL (UNII: 8470G57WFM)  
    AMMONIUM SULFATE (UNII: SU46BAM238)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54057-082-421250 mL in 1 PACKAGE; Type 0: Not a Combination Product08/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/15/2013
    Labeler - Afflink, Inc. (023121150)
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