Label: PERSONAL CARE ANTIBACTERIAL HAND- 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

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Chloroxylenol 0.3%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

  • When using this product

    ■ avoid contact with the eyes. In case of eye contact, flush with water.

  • Stop use and ask a doctor if

    ■ irritation and redness develops

  • Keep out of reach of children

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

  • Directions

    ■ pump into hands, wet as needed ■ lather vigorously for at least 15 seconds ■ wash skin, rinse thoroughly and dry

  • Inactive ingredients

    water (aqua), ammonium lauryl sulfate, cocamidopropyl betaine, ammonium chloride, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 40

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  ANTIBACTERIAL HAND
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-151
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-151-75221.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/16/2018
    2NDC:72133-151-15444 mL in 1 BOTTLE, PUMP; 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!