SAN E 2 HAND WASH 6265 (BENZALKONIUM CHLORIDE) SOAP [THE ROXXON CORPORATION]

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  • SAN E 2 HAND WASH 6265 (BENZALKONIUM CHLORIDE) SOAP [THE ROXXON CORPORATION]

SAN E 2 HAND WASH 6265 (BENZALKONIUM CHLORIDE) SOAP [THE ROXXON CORPORATION]
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NDC 62467-265-08, 62467-265-12, 62467-265-13, 62467-265-14
Set ID 968f74ff-5f98-4fc1-a975-2e5043c05b95
Category HUMAN OTC DRUG LABEL
Packager The Roxxon Corporation
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts Box OTC-Active Ingredient Section

    Benzalkonium Chloride 2.5%

  • 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

    ater, glycerin, isopropyl alcohol, disodium cocoamphodiproprionate, hydroxyethylcellulose, lauramine oxide,

    PEG-75 lanolin, citric acid, FD and C red no.4

  • SAN E 2 Hand Wash 6265 Drug Facts and Label

    product label

    SAN E 2 Hand Wash 6265 Label

  • INGREDIENTS AND APPEARANCE
    SAN E 2 HAND WASH 6265 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62467-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE25.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62467-265-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/17/2018
    2NDC:62467-265-121000 mL in 1 BAG; Type 0: Not a Combination Product10/17/2018
    3NDC:62467-265-13800 mL in 1 BAG; Type 0: Not a Combination Product10/17/2018
    4NDC:62467-265-081 in 1 BOX10/17/2018
    41000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/17/2018
    Labeler - The Roxxon Corporation (113133094)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(62467-265)
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