PALM (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]

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PALM (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]
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NDC 62257-544-06, 62257-544-07, 62257-544-10, 62257-544-11, 62257-544-12, 62257-544-13, 62257-544-14, 62257-544-17, 62257-544-27, 62257-544-35, 62257-544-55
Set ID a641ad83-1a28-4be7-a5ce-7ef5a192f326
Category HUMAN OTC DRUG LABEL
Packager ABC Compounding Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART333
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  • 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, DMDM hydantoin, citric acid, fragrance, FD and C yellow no.5, food red 10

  • Palm 6544 Drug Facts and Label

    product label

    6544 Palm Label

  • INGREDIENTS AND APPEARANCE
    PALM  
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-544
    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)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62257-544-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/1998
    2NDC:62257-544-07700 mL in 1 BAG; Type 0: Not a Combination Product12/21/1998
    3NDC:62257-544-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product12/21/1998
    4NDC:62257-544-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/1998
    5NDC:62257-544-121000 mL in 1 BAG; Type 0: Not a Combination Product12/21/1998
    6NDC:62257-544-061 in 1 BOX12/21/1998
    6NDC:62257-544-13800 mL in 1 BAG; Type 0: Not a Combination Product
    7NDC:62257-544-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/1998
    8NDC:62257-544-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product12/21/1998
    9NDC:62257-544-55208200 mL in 1 DRUM; Type 0: Not a Combination Product12/21/1998
    10NDC:62257-544-35132500 mL in 1 DRUM; Type 0: Not a Combination Product12/21/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/1998
    Labeler - ABC Compounding Co., Inc. (003284353)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(62257-544)
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