Label: ALOEGUARD ANTIMICROBIAL- chloroxylenol soap

  • 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 January 31, 2018

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  • Drug Facts Active ingredient

    Chloroxylenol 0.5% w/w

  • Purpose

    Antimicrobial

  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Uses

     Specially formulated for the sensitive skin of today's healthcare professional
     broad-spectrum antimicrobial hand cleaner
     for repeated washings on a daily basis

  • Warnings

    For external use only When using this product  do not use in or near eyes Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

     wet hands  apply AloeGuard  wash hands vigorously  rinse thoroughly.

  • Other information

     store at room temperature

  • Inactive ingredients:

    Water, Sodium Lauryl Sulfate, Cocamide MIPA, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Fragrance, C9-11 Pareth-6, Proplyene Glycol, Diazolidinyl Urea, Glycol Stearate, Isopropyl Myristate, Polyquaternium 7, Ammonium Chloride, Methyl Paraben, Propyl Paraben, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methylisothiazolinone, FD&C Blue #1, FD&C Green #8, D&C Orange #4.

  • PRINCIPAL DISPLAY PANEL - 800 mL Bag AloeGuard Antimicrobial Soap Net Contents 27 fl oz (800 ml) HealthLink A Family of Medical Products

    image description

  • INGREDIENTS AND APPEARANCE
    ALOEGUARD ANTIMICROBIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63843-509
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63843-509-11208000 mL in 1 DRUM; Type 0: Not a Combination Product08/20/2013
    2NDC:63843-509-17800 mL in 1 BAG; Type 0: Not a Combination Product08/20/2013
    3NDC:63843-509-18118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2013
    4NDC:63843-509-25532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2013
    5NDC:63843-509-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/20/2013
    Labeler - HealthLink (807714126)
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