Label: ANTIBACTERIAL- chloroxylenol soap

  • NDC Code(s): 62257-770-01, 62257-770-03, 62257-770-05, 62257-770-06, view more
    62257-770-07, 62257-770-08, 62257-770-09, 62257-770-10, 62257-770-11, 62257-770-12, 62257-770-13, 62257-770-14, 62257-770-15, 62257-770-16, 62257-770-17, 62257-770-18, 62257-770-19, 62257-770-20, 62257-770-24, 62257-770-27, 62257-770-28, 62257-770-35, 62257-770-55
  • Packager: ABC Compounding Co., Inc.
  • 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 9, 2014

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

  • Drug Facts Box OTC-Active Ingredient Section

    Chloroxylenol 0.3%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

  • Drug Facts Box OTC-Keep Out of Reach of Children Section

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

  • Drug Facts Box OTC-Dosage & Administration Section

    • wet hands and forearms
    • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
    • scrub thoroughly for 1 minute and rinse
  • Drug Facts Box OTC-Inactive Ingredient Section

    water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, fragrance, FD and C yellow no.5, food red 10

  • Antibacterial 1200 ml

    6544N3PA.jpg  Antibacterial 1200 ml  image of cartridge label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-770
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62257-770-061 in 1 BOX
    1800 mL in 1 BAG
    2NDC:62257-770-17532 mL in 1 BOTTLE, PLASTIC
    3NDC:62257-770-24118 mL in 1 BOTTLE, PLASTIC
    4NDC:62257-770-011200 mL in 1 CARTRIDGE
    5NDC:62257-770-03350 mL in 1 CARTRIDGE
    6NDC:62257-770-05540 mL in 1 BOTTLE, PLASTIC
    7NDC:62257-770-07700 mL in 1 BAG
    8NDC:62257-770-092000 mL in 1 CARTRIDGE
    9NDC:62257-770-101000 mL in 1 CARTRIDGE
    10NDC:62257-770-111000 mL in 1 BOTTLE, PLASTIC
    11NDC:62257-770-121000 mL in 1 BAG
    12NDC:62257-770-13800 mL in 1 BAG
    13NDC:62257-770-143785 mL in 1 BOTTLE, PLASTIC
    14NDC:62257-770-15946 mL in 1 BOTTLE, PLASTIC
    15NDC:62257-770-28149 mL in 1 BOTTLE, PLASTIC
    16NDC:62257-770-27800 mL in 1 CARTRIDGE
    17NDC:62257-770-55208200 mL in 1 DRUM
    18NDC:62257-770-081 in 1 BOX
    181000 mL in 1 BAG
    19NDC:62257-770-16236 mL in 1 BOTTLE, PLASTIC
    20NDC:62257-770-1850 mL in 1 BOTTLE, PLASTIC
    21NDC:62257-770-1918900 mL in 1 CONTAINER
    22NDC:62257-770-2075600 mL in 1 DRUM
    23NDC:62257-770-35132500 mL in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/09/2014
    Labeler - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(62257-770)