Label: PERSONAL CARE ANTIBACTERIAL DEODORANT- chloroxylenol soap

  • 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 6, 2018

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  • Active ingredient

    Chloroxylenol 0.1%

  • Purpose

    Antibacterial

  • Use

    ■for hand washing to decrease 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

  • 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

    ■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

  • Inactive ingredients

    Sodium Palmate, Sodium Tallowate, Sodium Cocoate, Sodium Palm Kernelate, Water, Glycerin, Fragrance,Sodium Chloride, Tetrasodium EDTA, FD&C Yellow No. 6, FD&C Yellow No. 5

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  ANTIBACTERIAL DEODORANT
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-048-0285 g in 1 BOX; Type 0: Not a Combination Product04/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2018
    Labeler - Delta Brands & Products LLC (080999173)
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