1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]

1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]
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NDC 62257-012-06, 62257-012-10, 62257-012-11, 62257-012-14, 62257-012-17, 62257-012-55
Set ID 4dc6367c-5347-4a5c-b0d0-e93a4277a849
Category HUMAN OTC DRUG LABEL
Packager ABC Compounding Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • 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, DMD hydantoin, fragrance, FD and C yellow no.5, food red 10

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  • 1012 Antimicrobial 6544 1 gallon bottle

    product label

    1012 Antimicrobial 1 gallon bottle  

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  • INGREDIENTS AND APPEARANCE
    1012 ANTIMICROBIAL  
    chloroxylenol soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62257-012
    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:62257-012-06 1 in 1 BOX 05/01/2013
    1 800 mL in 1 BAG; Type 0: Not a Combination Product
    2 NDC:62257-012-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013
    3 NDC:62257-012-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 05/01/2013
    4 NDC:62257-012-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013
    5 NDC:62257-012-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013
    6 NDC:62257-012-55 208200 mL in 1 DRUM; Type 0: Not a Combination Product 05/01/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 05/01/2013
    Labeler - ABC Compounding Co., Inc. (003284353)
    Establishment
    Name Address ID/FEI Business Operations
    ABC Compounding Co., Inc. 003284353 manufacture(62257-012)
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