Label: STRIKE BAC ANTIBACTERIAL HANDSOAP- chloroxylenol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 10, 2024

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  • Drug Facts

  • Active ingredients

    Chloroxylenol 0.25%

    Purpose

    Antiseptic

  • Use

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only

    Do not use

    in the eyes. In case of contact, flush thoroughly with water.

    Stop use and ask a doctor if

    irritation or redness develop, or if 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 and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.

  • Inactive ingredients

    5-Chloro-2-Methyl-4-Isothiazolin-3-One, Cocamide MIPA, Cocamidopropyl Betaine, D&C Red # 33, Fragrance, Glycerin, Glycol Distearate, 2-Methyl-4-Isothiazolin-3-One, Sodium Chloride, Sodium Laureth Sulfate, Water.

  • Strike Bac Antibacterial Handsoap

    image description

  • INGREDIENTS AND APPEARANCE
    STRIKE BAC ANTIBACTERIAL HANDSOAP 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62569-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62569-003-001 in 1 CARTON02/08/2023
    1473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/08/202307/15/2024
    Labeler - Genlabs Corporation (064594260)
    Registrant - Genlabs Corporation (064594260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher028311595manufacture(62569-003)
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