Label: ANTIMICROBIAL HAND- 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 July 21, 2021

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  • ACTIVE INGREDIENT

    CHLOROXYLENOL 0.04%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • A HIGH QUALITY, INSTANT LATHER FOAM WITH MOISTURIZERS AND EMOLLIENTS TO LEAVE SKIN FEELING CLEAN AND REFRESHED.
    • EXCELLENT GENERAL PURPOSE CLEANSER FOR EVERYDAY HAND WASHING.
    • DEVELOPS RICH LATHER.
    • IDEAL FOR:
    • EDUCATIONAL
    • LIGHT COMMERCIAL
    • HEALTH CLUB FACILITIES
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    IN CASE OF CONTACT WITH EYES, FLUSH EYES WITH WATER AND SEEK MEDICAL ADVICE.

    DISCONTINUE USE AND CONSULT A PHYSICIAN IF IRRITATION DEVELOPS.

    CONSULT WITH A PHYSICIAN IF INGESTED.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • APPLY ONE PUMP OF ANTIMICROBIAL HAND SOAP TO HANDS.
    • RUB HANDS TOGETHER TO SPREAD LATHER.
    • WASH FOR 15-20 SECONDS.
    • RINSE AND DRY HANDS THOROUGHLY.

  • INACTIVE INGREDIENTS

    WATER, COCAMIDOPROPYL BETAINE, AMIDES, COCO, N-(2-HYDROXYPROPYL), PCMX, RED COLOR

  • PRINCIPAL DISPLAY PANEL

    01B LBL (CARTON)_Antimicrobial Hand Soap 4x8_1gal

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77397-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77397-103-113785 mL in 1 JUG; Type 0: Not a Combination Product07/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/16/2021
    Labeler - AMMMM INC (808060680)
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