Label: FIRST AID ANTISEPTIC- benzalkonium chloride and benzocaine 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 August 29, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzaikonium Chloride 0.1%

    Benzocaine 5.0%

  • Purpose

    First aid antiseptic

    Topical pain relief

  • Uses

    First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

  • Warnings

    For external use only.

    Flammable keep away from fire or flame

    Do not use

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

    Keep out of reach of children.

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

    Stop use and ask a doctor if condition persists or gets worse

  • Directions

    • spray over cleaned affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 ask a doctor
  • Inactive ingredients

    isopropyl alcohol, purified water

  • Principal Display Panel - Bottle Label

    first aid
    ANTISEPTIC
    SPRAY

    Treats Minor Cuts, Scrapes and Burns
    Helps Prevent Infection and Relieves Pain

    Package Not Child Resistant

    2 fl. oz. (59.15ml)

    Manufactured for

    Provision Medical Products Palm Desert, CA 92211

    Figure
  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    benzalkonium chloride and benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 g  in 1 L
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine50 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    isopropyl alcohol (UNII: ND2M416302)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-3501-10.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2014
    Labeler - Provision Medical (036936831)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-3501)
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