Label: DURISAN- benzalkonium chloride liquid

  • 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 December 2, 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, benzoic acid, sorbic acid

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    DURISAN 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71120-117
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71120-117-01300 mL in 1 PACKAGE; Type 0: Not a Combination Product10/08/2020
    2NDC:71120-117-021000 mL in 1 PACKAGE; Type 0: Not a Combination Product10/08/2020
    3NDC:71120-117-033785 mL in 1 PACKAGE; Type 0: Not a Combination Product10/08/2020
    4NDC:71120-117-0450 mL in 1 PACKAGE; Type 0: Not a Combination Product10/08/2020
    5NDC:71120-117-05550 mL in 1 PACKAGE; Type 0: Not a Combination Product10/08/2020
    6NDC:71120-117-06250 mL in 1 PACKAGE; Type 0: Not a Combination Product10/08/2020
    7NDC:71120-117-071000 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Durisan085479946manufacture(71120-117)
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