Label: FIRST AID- benzalkonium chloride and benzocaine spray 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • Active Ingredients

    Benzalkonium Chloride 0.1%

    Benzocaine 5.0%

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  • Purpose

    Topical Antiseptic

    Topical Anethetic

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  • Uses

    First aid to help protect against skin infection and for the temporary relief of pain and itching in

    • minor cuts and scrapes
    • bites
    • skin irritation
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  • Warnings

    For external use only.

    Flammable, keep away from heat or flame

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  • DO NOT USE

    Do not use

    • in or near the eyes
    • over large portions of the body
    • in large quantities, particularly over raw surfaces or blistered areas
    • on deep or puncture wounds
    • on animal bites
    • on serious burns
    • longer than 7 days unless directed by a doctor
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  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
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  • 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. 1-800-222-1222

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  • Directions

    • 2.2ex0em2.2ex0emclean affected area and spray 1 to 3 times daily
    • 2.2ex0em2.2ex0emmay be covered with a sterile bandage

    Children under 2 years of age: ask a doctor

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  • Inactive Ingredients

    Isopropyl Alcohol, Purified Water

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  • INGREDIENTS AND APPEARANCE
    FIRST AID 
    benzalkonium chloride, benzocaine spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0212
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg  in 1000 mg
    BENZOCAINE (BENZOCAINE) BENZOCAINE 50 mg  in 1000 mg
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL ALCOHOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0212-1 60 mg in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333A 02/06/1996
    Labeler - HART Health (069560969)
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