Label: ANTISEPTIC- benzalkonium chloride 0.13% spray

  • NDC Code(s): 69396-153-02
  • Packager: Trifecta Pharmaceuticals USA, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 18, 2024

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  • Active Ingredient

    Benzalkonium chloride .13%

  • Purpose

    First Aid Antiseptic

  • INDICATIONS & USAGE

    First Aid to help prevent infection in minor cuts, scrapes, and burns.

  • Warnings

    For External Use Only

    Flammable. Keep away from fire or flame.

  • Stop use and ask a doctor

    • If the condition persists or gets worse.
  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • Clean affected area and spray 1 to 3 times daily
    • May be covered wiht a sterile bandage
    • Not to be used on children under 12 years of age
  • Do Not Use

    • Near eyes or mucous membranes
    • on deep or puncture wounds, animal bites, or serious burns
    • over large areas of the body
    • for more than one week unless directed by a doctor
  • Other information

    • Store at controlled room temperature 68º-77ºF (20º-25ºC)

  • Inactive Ingredients

    Purified water, alcohol

  • Questions or Comments

    Call 1-888-296-9067

  • Distributed By:

    Trifecta Pharmaceuticals USA, LLC.

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    SKU: 4069-FBA

    Made in China

  • Packaging

    4080 GLOBE ANTISEPTIC SPRAY 2OZ LOOSE 030824 CDER

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride 0.13% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-153-020.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/18/2024
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)
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