Label: ANTIMICROBIAL FOAM- 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 April 11, 2022

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  • ACTIVE INGREDIENTS

    CHLOROXYLENOL 0.45%

  • PURPOSE

    ANTISEPTIC

  • USES

    HELPS PREVENT CROSS CONTAMINATION BY HAND CONTACT TO REDUCE INCIDENCE ON NOSOCOMIAL INFECTION.

  • WARNINGS

    FOR EXTERNAL USE ONLY. AVOID ANY FOODS CONTAMINATION DURING APPLICATION AND STORAGE.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES FLUSH THOROUGHLY WITH WATER.

    AVOID CONTACT WITH BROKEN SKIN.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS OR CONDITION PERSISTS FOR MORE THAN 72 HOURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    WET HANDS AND FOREARMS. APPLY A SMALL AMOUNT OF SOAP AND SCRUB THOROUGHLY FOR 1 MINUTE. RINSE THOROUGHLY. DRY HANDS COMPLETELY.

  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, POLYQUATERNIUM 7, FRAGRANCE, CITRIC ACID, FD&C YELLOW #5 (CAS #1934-21-0), FD&C rED #4 (CAS #548-53-2), D&C RED #33 (CAS #567-66-6), FD&C BLUE #1 (CAS #3844-15-9).

  • OTHER SAFETY INFORMATION

    CHEMICAL EMERGENCY #: 1-800-255-3924

  • PRINCIPAL DISPLAY PANEL

    Antimicrobial Foam Soap Label

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAM 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67106-7231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.45 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67106-7231-1800 mL in 1 BOX; Type 0: Not a Combination Product03/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/29/2018
    Labeler - Sky Systems Co., Inc (621886548)
    Registrant - Sky Systems Co., Inc (621886548)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sky Systems Co., Inc621886548manufacture(67106-7231)
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