Label: PROBLEND ANTIBACTERIAL FOAMING SILK- benzalkonium chloride soap

  • 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 September 19, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Benzalkonium Chloride 0.13%............Antibacterial

  • INDICATIONS & USAGE

    Uses

    For hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings For external use only.

  • WHEN USING

    When using this product Avoid contact with eyes. In case of eye contact, flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops. or if condition persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Contdrol Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump into hands, wet as needed.

    Lather vigorously for at least 15 seconds.

    Wash skin, rinse thoroughly and dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Laurtrimonium Chloride, Alkyl Polyglucoside, Citric Acid, Dye, Fragrance.

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • PRINCIPAL DISPLAY PANEL

    Front label1.25 L 76250-101-25

  • PRINCIPAL DISPLAY PANEL

    back label1.25 L 76250-101-25

  • PRINCIPAL DISPLAY PANEL

    55 G 76250-101-5555 G 76250-101-55

  • PRINCIPAL DISPLAY PANEL

    275 G 76250-101-75275 G 76250-101-75

  • PRINCIPAL DISPLAY PANEL

    330 G 76250-101-33330 G 76250-101-33

  • INGREDIENTS AND APPEARANCE
    PROBLEND ANTIBACTERIAL FOAMING SILK 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76250-101-251250 g in 1 CARTRIDGE; Type 0: Not a Combination Product08/19/2021
    2NDC:76250-101-55206440 g in 1 DRUM; Type 0: Not a Combination Product09/15/2021
    3NDC:76250-101-751032202 g in 1 CONTAINER; Type 0: Not a Combination Product09/15/2021
    4NDC:76250-101-331249186 g in 1 CONTAINER; Type 0: Not a Combination Product09/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/19/2021
    Labeler - Seatex LLC (026647404)
    Registrant - Seatex LLC (026647404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seatex LLC026647404label(76250-101) , manufacture(76250-101) , pack(76250-101)
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