Label: ROYAL ANTIBACTERIAL FOAM HAND WASH- chloroxylenol solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 21, 2023

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  • Active ingredient

    Chloroxylenol, 0.5%

    Purpose

    Antibacterial

  • Uses

    • For handwashing to reduce bacteria on the skin
  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes. In case of eye contact, flush with water

    Keep out of reach of children.

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

  • Directions

    • Apply foaming cleanser to dry hands
    • Rub hands together to spread lather
    • Wash for 15-20 seconds
    • Rinse & dry hands thoroughly
  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, SODIUM C14-16 OLEFIN SULFONATE, Hydrogenated castor Oil, DMDM Hydantoin, Citric Acid, Fragrance, FD&C Blue No.1, FD&C Yellow No.5.

  • PRINCIPAL DISPLAY PANEL

    Royal Product_Labels_Antibacterial Foam Hand Wash

  • INGREDIENTS AND APPEARANCE
    ROYAL ANTIBACTERIAL FOAM HAND WASH 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70415-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70415-201-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/04/2016
    Labeler - CWGC LA Inc. (034967904)
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