Label: ANTIMICROBIAL ANTISEPTIC HAND WASH- 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

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    For hand-washing to decrease bacteria on the skin

    Antimicrobial hand cleanser

    Recommended for repeated use

  • Drug Facts Box OTC-Warnings Section

    For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

  • Drug Facts Box OTC-When Using Section

    Do not use in the eyes.

    If contact occurs, rinse eyes thoroughly with water

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.


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

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Drug Facts Box OTC-Dosage & Administration Section

    Wet hands and forearms

    Apply 5ml (teaspoonful) or palmful to hands and forearms

    Scrub thoroughly for 1 minute. Rinse and repeat.





  • Drug Facts Box OTC-General Precautions Section

    Store at room temperature

  • Drug Facts Box OTC-Inactive Ingredient Section

    Water, Decyl Glucoside, Sodium Laureth Sulfate, Cocamide DEA, Propylene Glycol, Glycol Distearate, Cocomide MEA, Laureth-10, Sodium Chloride, Citric Acid, Fragrance, Hexahydro-1,3,5,-tris(2-hydroxyethyl)-s-triazine, Direct Blue 86

  • Antimicrobial Antiseptic Hand Wash 6620 18oz

    662018P6318.jpg  Antimicrobial Antiseptic Hand Wash 18ozimage of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL ANTISEPTIC HAND WASH 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-620
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68345-620-061 in 1 BOX
    1800 mL in 1 BAG
    2NDC:68345-620-17532 mL in 1 BOTTLE, PLASTIC
    3NDC:68345-620-143785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33301/01/2010
    Labeler - PSS World Medical, Inc. (101822682)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture
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