Label: CHEMSEPTIC- chloroxylenol soap

  • NDC Code(s): 59503-0544-1, 59503-0544-2, 59503-0544-3, 59503-0544-4, view more
    59503-0544-5, 59503-0544-6, 59503-0544-7, 59503-0544-8, 59503-0544-9
  • Packager: Rochester Midland Corporation
  • 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 December 26, 2018

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

  • Drug Facts Box OTC-Active Ingredient Section

    Chloroxylenol 0.3%

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  • Drug Facts Box OTC-Purpose Section

    Antiseptic

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  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

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  • Drug Facts Box OTC-Warnings Section

    For external use only

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  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

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  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

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

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

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  • 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
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  • 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

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  • Chemseptic 1 gallon

    product label

    Chemseptic  1 gallon label

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  • INGREDIENTS AND APPEARANCE
    CHEMSEPTIC 
    chloroxylenol soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59503-0544
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59503-0544-1 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2004
    2 NDC:59503-0544-2 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2004
    3 NDC:59503-0544-3 18900 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2004
    4 NDC:59503-0544-4 208200 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2004
    5 NDC:59503-0544-5 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2004
    6 NDC:59503-0544-6 2500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2004
    7 NDC:59503-0544-7 75600 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2004
    8 NDC:59503-0544-8 132500 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2004
    9 NDC:59503-0544-9 650 mL in 1 BAG; Type 0: Not a Combination Product 03/30/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 03/30/2004
    Labeler - Rochester Midland Corporation (002207041)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    Name Address ID/FEI Business Operations
    ABC Compounding Co., Inc. 003284353 manufacture(59503-0544)
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