Label: DURISAN- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 8, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antiseptic

  • Use

    To decrease bacteria on the skin.

  • Warnings

    For external use only.

  • WHEN USING

    When using this product keep out of eyes. In case of contact eyes with water.

    Stop use and consult a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Pump onto dry skin. Lather vigorously for 20 seconds.
    • Rinse hands and dry thoroughly.
  • Inactive ingredients

    Water, cocamidopropyl betaine, glycerin, cetrimonium chloride, benzyl alcohol, disodium EDTA, fragrance, benzoic acid, sorbic acid, citric acid, violet 2 (CI 60730)

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    DURISAN 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71120-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SORBIC ACID (UNII: X045WJ989B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71120-116-01300 mL in 1 PACKAGE; Type 0: Not a Combination Product10/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/08/2020
    Labeler - Sanit Technologies LLC (075711022)
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