Label: ANTISEPTIC- 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 December 12, 2022

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  • ACTIVE INGREDIENT

    CHLOROXYLENOL 0.45%

  • PURPOSE

    ANTISEPTIC

  • USES

    • HELP PREVENT CROSS CONTAMINATION BY HAND CONTACT TO REDUCE INCIDENCE ON NOSOCOMIAL INFECTION.
  • WARNINGS

    • FOR EXTERNAL USE ONLY.

    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

    • CONDITIONS WORSEN OR IRRITATION PERSISTS.
    • IRRITATION OR REDNESS DEVELOPS AND PERSISTED FOR MORE THAN 72 HOURS.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    • IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.
  • DIRECTIONS

    • WET HANDS AND FOREARMS.
    • APPLY 5 ML (TEASPOONFULL) OR PALMFUL TO HANDS AND FOREARMS.
    • SCRUB THOROUGHLY FOR 1 MINUTE. RINSE AND REPEAT.
  • OTHER INFORMATION

    • STORE AT 20-25°C (60 TO 77°F)
  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, POLYQUATERNIUM 7, GLYCOL STEARATE, SODIUM CHLORIDE, CITRIC ACID.

  • PRINCIPAL DISPLAY PANEL

    Antiseptic 800 V2 Rev2

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67106-7014
    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)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67106-7014-1800 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 finalpart333A03/27/2018
    Labeler - Sky Systems Co., Inc (621886548)
    Registrant - Sky Systems Co., Inc (621886548)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sky Systems Co., Inc621886548manufacture(67106-7014)
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