Label: ALOEGUARD- 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 March 22, 2010

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  • Drug Facts Box OTC-Active Ingredient Section

    Chloroxylenol 0.5% w/w

  • Drug Facts Box OTC-Purpose Section

    Antimicrobial

  • Drug Facts Box OTC-Indications & Usage Section

    Specially formulated for the sensitive skin of today's healthcare professional

    broad-spectrum antimicrobial hand cleaner

    for repeated washings on a daily basis

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not use in or near eyes


  • Drug Facts Box OTC-Keep Out of Reach of Children Section

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

  • Drug Facts Box OTC-Dosage & Administration Section

    wet hands

    apply AloeGuard

    wash hands vigorously

    rinse thoroughly




  • Drug Facts Box OTC-General Precautions Section

    store at room temperature

  • Drug Facts Box OTC-Inactive Ingredient Section

    Water, TEA lauryl sulfate, Cocamide DEA, Urea, Aloe vera gel, Fragrance, Polyquaternium 7, Glycol Stearate, DMDM hydantoin, Sodium chloride, Methyl paraben, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Propyl paraben, FDC Blue 1, FDC Green 8, FDC Orange 4

  • AloeGuard 6729 18oz

    672918P6318.jpg   AloeGuard 18ozimage of bottle label

  • INGREDIENTS AND APPEARANCE
    ALOEGUARD 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63843-729
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIGLYCOL STEARATE (UNII: 94YQ11Y95F)  
    TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    UREA (UNII: 8W8T17847W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    D&C GREEN NO. 8 (UNII: I2W85YOX9L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63843-729-061 in 1 BOX
    1800 mL in 1 BAG
    2NDC:63843-729-17532 mL in 1 BOTTLE, PLASTIC
    3NDC:63843-729-143785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/31/2009
    Labeler - HealthLink (807714126)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture
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