Label: POWERHOUSE ULTRA DISH ANTIBACTERIAL- 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 19, 2018

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  • Active ingredient

    Chloroxylenol 0.30%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hands only

  • When using this product

    ■ do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    ■ irritation and redness develops ■ condition persists for more than 72 hours

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ wet hands ■ apply palmful to hands ■ scrub thoroughly ■ rinse thoroughly

  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Lauramine Oxide,Sodium Lauryl Sulfate, Alcohol Denat. Sodium Chloride, Tetrasodium EDTA, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, Red 40

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    POWERHOUSE  ULTRA DISH ANTIBACTERIAL
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-152-25740 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/16/2018
    Labeler - Delta Brands & Products LLC (080999173)
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