Label: PALM - chloroxylenol soap

  • NDC Code(s): 62257-544-01, 62257-544-03, 62257-544-05, 62257-544-06, view more
    62257-544-07, 62257-544-08, 62257-544-09, 62257-544-10, 62257-544-11, 62257-544-12, 62257-544-13, 62257-544-14, 62257-544-15, 62257-544-16, 62257-544-17, 62257-544-18, 62257-544-19, 62257-544-20, 62257-544-24, 62257-544-27, 62257-544-28, 62257-544-35, 62257-544-55
  • Packager: ABC Compounding Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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 no.5, food red 10

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  • Palm 6544 35 gal drum

    654435PA.jpg  Palm 35 gal drumimage of drum label

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  • INGREDIENTS AND APPEARANCE
    PALM  
    chloroxylenol soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62257-544
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PROPYLENE GLYCOL  
    SODIUM LAURETH SULFATE  
    CITRIC ACID MONOHYDRATE  
    DECYL GLUCOSIDE  
    SODIUM CHLORIDE  
    COCO MONOISOPROPANOLAMIDE  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62257-544-06 1 in 1 BOX
    1 800 mL in 1 BAG
    2 NDC:62257-544-17 532 mL in 1 BOTTLE, PLASTIC
    3 NDC:62257-544-24 118 mL in 1 BOTTLE, PLASTIC
    4 NDC:62257-544-01 1200 mL in 1 CARTRIDGE
    5 NDC:62257-544-03 350 mL in 1 CARTRIDGE
    6 NDC:62257-544-05 540 mL in 1 BOTTLE, PLASTIC
    7 NDC:62257-544-07 700 mL in 1 BAG
    8 NDC:62257-544-09 2000 mL in 1 CARTRIDGE
    9 NDC:62257-544-10 1000 mL in 1 CARTRIDGE
    10 NDC:62257-544-11 1000 mL in 1 BOTTLE, PLASTIC
    11 NDC:62257-544-12 1000 mL in 1 BAG
    12 NDC:62257-544-13 800 mL in 1 BAG
    13 NDC:62257-544-14 3785 mL in 1 BOTTLE, PLASTIC
    14 NDC:62257-544-15 946 mL in 1 BOTTLE, PLASTIC
    15 NDC:62257-544-28 149 mL in 1 BOTTLE, PLASTIC
    16 NDC:62257-544-27 800 mL in 1 CARTRIDGE
    17 NDC:62257-544-55 208200 mL in 1 DRUM
    18 NDC:62257-544-08 1 in 1 BOX
    18 1000 mL in 1 BAG
    19 NDC:62257-544-16 236 mL in 1 BOTTLE, PLASTIC
    20 NDC:62257-544-18 50 mL in 1 BOTTLE, PLASTIC
    21 NDC:62257-544-19 18900 mL in 1 CONTAINER
    22 NDC:62257-544-20 75600 mL in 1 DRUM
    23 NDC:62257-544-35 132500 mL in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/1998
    Labeler - ABC Compounding Co., Inc. (003284353)
    Establishment
    Name Address ID/FEI Business Operations
    ABC Compounding Co., Inc. 003284353 manufacture(62257-544)
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