Label: DISINFECTANT HAND WASH- chloroxylenol liquid

  • 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 9, 2020

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  • SPL UNCLASSIFIED SECTION

    Disinfectant Hand Wash

  • Active Ingredient(s)

    CHLOROXYLENOL 0.22g/100mL

    Purpose: Antiseptic

  • Purpose

    Antiseptic, Disinfectant Hand Wash

  • Use

    Disinfectant Hand Wash to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    SODIUM LAURETH-5 SULFATE
    COCAMIDOPROPYL BETAINE
    DECYL GLUCOSIDE
    EDETATE SODIUM
    CITRIC ACID MONOHYDRATE
    Medicinal Glycerin
    METHYLCHLOROISOTHIAZOLINONE
    METHYLISOTHIAZOLINONE
    Vitamin E
    Brilliant Blue
    Purity Water

  • Package Label - Principal Display Panel

    350 mL NDC: 74974-007-01

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT HAND WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74974-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.22 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74974-007-01350 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    Labeler - Swashes (Shenzhen) Co., Ltd. (421263450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swashes (Shenzhen) Co., Ltd.421263450manufacture(74974-007)
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