Label: SIERRA SOFT ANTIBACTERIAL 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 September 21, 2023

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  • Drug Facts

  • 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 right 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 Yellow No. 5, FD&C Red No. 4.

  • ​Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SIERRA SOFT ANTIBACTERIAL WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70415-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 g  in 1 L
    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 YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70415-001-011 L in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2016
    Labeler - CWGC LA Inc. (034967904)
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