Label: STERILE ANTIBACTERIAL WOUND WASH- benzalkonium chloride spray

  • 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 June 23, 2016

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  • Active ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    First Aid Antiseptic

  • Uses

    first aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

  • Warnings


    For external use only


    Do not use



    • in eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use

    in the event of deep puncture wounds, animal bites or severe burns

    When using this product

    use only as directed

    Stop use and ask a doctor if


    • conditions worsens
    • symptoms persists for more than seven days
    • symptoms disappear and reappear again within a few days

    Keep out of reach of childrens

    If swallowed get medical help or contact a Poison Control Center right away

  • Directions


    • clean the affected area
    • shake well
    • remove seal and cap
    • spray a small amount of this product on the area 1 to 3 times a day
    • may be covered with a sterile bandage. If bandaged, let dry first
  • Other information


    • contents under pressure
    • do not puncture or incinerate can
    • do not drop can
    • do not store at temperatures above 120 degrees F.
    • do not use if tamper evident seal is broken
  • Inactive ingredients

    Sodium Chloride U.S.P., Aloe Barbadensis Leaf Extract , Purified Water

  • Questions?

    1-800-831-7210 

  • Principal Display Panel

    NDC 70043-390-04

    Ascot Pharmaceutical Inc.

    Sterile Antibacterial

    WOUND WASH

    FIRST AID CLEANSER

    • Cleans wounds painlessly and effectively
    • No burn or sting
    • No Preservatives
    • No alcohol
    • No fragrance

    ECO-FRIENDLY

    No Fluorinated Hydrocarbon Propellants



    • COMPRESSED AIR IS THE PROPELLANT
    • SPRAYS UPSIDE DOWN OR AT ANY ANGLE
    • NO PUMPING NEEDED

    3600 CONTINUOUS SPRAY

    4 FL.OZ (120 mL)

    Label





  • INGREDIENTS AND APPEARANCE
    STERILE ANTIBACTERIAL WOUND WASH  
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70043-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70043-390-04120 mL in 1 CAN; Type 0: Not a Combination Product06/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2016
    Labeler - Ascot Pharmaceuticals, Inc. (079915219)
    Establishment
    NameAddressID/FEIBusiness Operations
    BOV Solutions Inc800463486manufacture(70043-390)
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