Label: GLOBAL HOUSEHOLD ANTIBACTERIAL HAND ORANGE- chloroxylenol gel

  • 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 15, 2020

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  • Drug Facts

  • Active Ingredient

    Chloroxylenol 0.30%

    Purpose

    Antibacterial hand soap

  • USE

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

    Keep Out of reach of children,

    In case of accidental ingestion, drink a glass of water to dilute. if eye contact occurs, rinse thoroughly with water.

  • Directions

    • Wet hands and forearms. Apply 5 ml or palmfu to hands and forearms. Scrub thoroughly for 30 seconds and rinse.
  • Inactive ingredients.

    • water, sodium, lauril sulfate, lauramine oxide, sodium laureth sulfate, alcoholdenat., phenoxyethanol,sodium chloride,PPG-26,PEI-14 PGE 24/PPG-16 copolymer, sodium hydroxide, fragance, C9-11, pareth-8, tetrasodium glumate diacetate, yellow 5, methylisothiazoinone, blue 1
  • Package Labeling

    Bottle3

  • INGREDIENTS AND APPEARANCE
    GLOBAL HOUSEHOLD ANTIBACTERIAL HAND ORANGE 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72146-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM (UNII: 9NEZ333N27)  
    LAURYL SULFATE (UNII: DIQ16UC154)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PPG-26 (UNII: V86KZL3H2Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72146-046-003785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product09/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/14/2020
    Labeler - Target Price Inc (081086884)
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