Label: DURISAN- benzalkonium chloride liquid

  • NDC Code(s): 71120-115-01
  • Packager: Sanit Technologies LLC
  • 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 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:71120-115
    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)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71120-115-01300 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)