Label: AEROWOUND BLOOD CLOTTING FIRST AID- benzethonium chloride and lidocaine aerosol, 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 20, 2014

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  • Active Ingredients

    Benzethonium Chloride 0.2% w/w
    Lidocaine 4% w/w

  • Purpose

    Topical Antiseptic
    Topical Anesthetic 

  • Uses

    for help in control of superficial bleeding and temporary relief of pain of:

    • minor cuts and scrapes
    • minor burns
  • Warnings

    For external use only

    Flammable

    • keep away from flame
    • contents under pressure
    • do not puncture or incinerate
    • do not expose to temperatures above 120°F
  • Do not use

    • in or near mucous membranes
    • on serious burns
    • on raw surfaces
    • on deep puncture wounds
    • for a prolonged period of time
    • on blistered areas
    • on a large portion of the body
    • on animal bites
  • Stop use and ask doctor if

    • redness, swelling, or irritation occurs
    • infection occurs
    • condition persists or worsens
    • symptoms persist for more than 7 days
  • Keep out of reach of children.

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

  • Directions

    • shake can well before using
    • hold 6-8 inches from moist injured area
    • spray until area is covered
    • for adult use only
    • not intended for use on children
    • scab-like cover will gradually disappear as healing takes place or may be removed with soap and water
  • Inactive Ingredients

    Isobutane, Isopropyl Myristate, Karaya, n-Butane, Propane, Silica, Silicone, Sorbitan Monooleate, Talc, Tragacanth

  • Principal Display

    image description

  • INGREDIENTS AND APPEARANCE
    AEROWOUND BLOOD CLOTTING FIRST AID 
    benzethonium chloride and lidocaine aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-114(NDC:52982-106)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE756.5 mg  in 85 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE76.5 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KARAYA GUM (UNII: 73W9IQY50Q)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    3-(TRIETHOXYSILYL)PROPYLAMINE (UNII: L8S6UBW552)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TALC (UNII: 7SEV7J4R1U)  
    TRAGACANTH (UNII: 2944357O2O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-114-1085 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/20/2014
    Labeler - Aero Healthcare, LLC. (008186174)
    Registrant - Dixon Investments, Inc. (115315822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments, Inc.115315822manufacture(55305-114)
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