Label: ANTISEPTIC FIRST AID- 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 October 6, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzalkonium 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

    • clean affected area
    • spray over the 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

  • Questions?

    call 203-857-5361

  • Principal Display Panel - Bottle Label

    13-080

    ANTISEPTICS

    FIRST AID ONLY®

    Antiseptic
    First Aid Spray

    Antiseptic first aid spray
    with pain reliever for use
    on minor cuts, scrapes
    and burns

    4 fl oz (118.3ml)

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC FIRST AID 
    benzalkonium chloride and benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0931
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 mg  in 1 g
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    isopropyl alcohol (UNII: ND2M416302)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0931-01107 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/06/2014
    Labeler - Acme United Corp (001180207)
    Registrant - Safetec of America, Inc (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(0924-0931)
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