Label: ANTIMICROBIAL- 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.

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Updated December 12, 2022

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  • ACTIVE INGREDIENT

    CHLOROXYLENOL @ 0.45%

    TRICLOSAN @ 0.06%

  • PURPOSE

    ANTISEPTIC

  • USES

    HELP PREVENT CROSS CONTAMINATION BY HAND CONTACT TO REDUCE INCIDENCE ON NASOCOMIAL INFECTION.

  • WARNINGS

    • FOR EXTERNAL USE ONLY. AVOID FOOD CONTAMINATION DURING APPLICATION AND STORAGE.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH THE EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER.
    • AVOID CONTACT WITH BROKEN SKIN.

    STOP USE OF THIS PRODUCT 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 A SMALL AMOUNT OF SOAP AND SCRUB THOROUGHLY FOR 1 MINUTE.
    • RINSE THOROUGHLY.
    • DRY HANDS COMPLETELY.
  • OTHER INFORMATION

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

    WATER, SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, POLYQUATERNIUM-7, FRAGRANCE, SODIUM CHLORIDE, CITRIC ACID, COLOR DYE.

  • QUESTIONS?

    CALL 909-923-7040

  • PRINCIPAL DISPLAY PANEL

    7031 Antimicrobial Lotion Soap_UC_800mL

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67106-7031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.06 g  in 100 mL
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.45 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67106-7031-812 in 1 BOX12/10/1990
    1NDC:67106-7031-1800 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/10/1990
    Labeler - Sky Systems Co., Inc (621886548)
    Registrant - Sky Systems Co., Inc (621886548)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sky Systems Co., Inc621886548manufacture(67106-7031)
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