YOUR LABEL HERE BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]

YOUR LABEL HERE BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]
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NDC 52982-106-03
Set ID b07ff274-6d4e-424a-89d2-683921947889
Category HUMAN OTC DRUG LABEL
Packager Dixon Investments, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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
    for temporary relief of pain and to help protect against skin infestion in minor cuts
    minor cuts
    minor 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 eyes or other mucous membranes
    on large portions of the body
    in case of deep or puncture wounds
    on raw surfaces
    on blistered areas
    on animal bites
    on serious burns

  • 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
    scan-like cover will gradually disappear as healing takes place or may be removed with soap and water
    for adult institutional use only
    not intended for use on children

  • Inactive Ingredients

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

  • Principal Display

    label

  • INGREDIENTS AND APPEARANCE
    YOUR LABEL HERE BLOOD CLOTTING FIRST AID 
    benzethonium chloride and lidocaine aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3400 mg  in 85 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 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:52982-106-0385 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/05/2013
    Labeler - Dixon Investments, Inc. (115315822)
    Registrant - Dixon Investments, Inc. (115315822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments, Inc.115315822manufacture(52982-106)

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