Label: OSCEOLA SUPPLY INC 6176- chloroxylenol soap

  • NDC Code(s): 62672-300-01, 62672-300-03, 62672-300-05, 62672-300-07, view more
    62672-300-09, 62672-300-10, 62672-300-11, 62672-300-12, 62672-300-13, 62672-300-14, 62672-300-15, 62672-300-16, 62672-300-17, 62672-300-18, 62672-300-19, 62672-300-20, 62672-300-24, 62672-300-27, 62672-300-28, 62672-300-35, 62672-300-55
  • Packager: OSCEOLA SUPPLY, 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 July 22, 2016

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  • Drug Facts Box OTC-Active Ingredient Section

    Chloroxylenol 0.6%


  • 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, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, propylene glycol, sodium chloride, PEG-75 lanolin, sodium styrene/PEG-10 maleate/nonoxynol-10 maleate/acrylates copolymer, boric acid, fragrance, methylparaben, propylparaben, aloe barbadensis

  • Medicated Lotion Soap 6176 Label

    Medicated Lotion Soap 6176image description6176M4P5136.jpg

  • INGREDIENTS AND APPEARANCE
    OSCEOLA SUPPLY INC 6176 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62672-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62672-300-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    2NDC:62672-300-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    3NDC:62672-300-011200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
    4NDC:62672-300-03350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
    5NDC:62672-300-05540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    6NDC:62672-300-07700 mL in 1 BAG; Type 0: Not a Combination Product07/22/2016
    7NDC:62672-300-092000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
    8NDC:62672-300-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
    9NDC:62672-300-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    10NDC:62672-300-121000 mL in 1 BAG; Type 0: Not a Combination Product07/22/2016
    11NDC:62672-300-13800 mL in 1 BAG; Type 0: Not a Combination Product07/22/2016
    12NDC:62672-300-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    13NDC:62672-300-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    14NDC:62672-300-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    15NDC:62672-300-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/22/2016
    16NDC:62672-300-552082 mL in 1 DRUM; Type 0: Not a Combination Product07/22/2016
    17NDC:62672-300-16236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    18NDC:62672-300-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2016
    19NDC:62672-300-191890 mL in 1 CONTAINER; Type 0: Not a Combination Product07/22/2016
    20NDC:62672-300-207560 mL in 1 DRUM; Type 0: Not a Combination Product07/22/2016
    21NDC:62672-300-351325 mL in 1 DRUM; Type 0: Not a Combination Product07/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/22/2016
    Labeler - OSCEOLA SUPPLY, INC. (809050479)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(62672-300)
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