Label: ULTRA DISH WASHING DETERGENT- 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

    Ultra Dish Washing Detergent

  • Active Ingredient(s)

    CHLOROXYLENOL 1g/L

    Purpose: Antiseptic

  • Purpose

    Antiseptic, Ultra Dish Washing Detergent

  • Use

    Ultra Dish Washing Detergent 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

    CHLOROXYLENOL
    C18H30O3S
    Sodium Hydroxide
    Sodium Alcohol Ether Sulphate
    Coconut Diethanol Amide
    Ethylene diamine tetraacetic acid tetrasodium
    Sodium chloride
    Kathon.cmit/mit
    Purity Water

  • Package Label - Principal Display Panel

    1 L NDC: 74974-008-01

    label

  • INGREDIENTS AND APPEARANCE
    ULTRA DISH WASHING DETERGENT 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74974-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL1 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WATER (UNII: 059QF0KO0R)  
    DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74974-008-011 L 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(74974-008)
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