YOUR LOGO HERE POISON IVY FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]

YOUR LOGO HERE POISON IVY FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [DIXON INVESTMENTS, INC.]
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NDC 52982-107-03
Set ID 3327ff0f-c67e-446d-b5a5-b5e388cee999
Category HUMAN OTC DRUG LABEL
Packager Dixon Investments, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Benzethonium Chloride 0.15% w/w
    Benzocaine 5.0% w/w 

  • Purpose

    Topical Antiseptic
    Topical Anesthetic

  • Uses

    For temporary relief of pain and itching and to help protect against infection in
    minor skin irritations
    rashes due to poison ivy, poison sumac and insect bites 

  • Warnings

    For external use only

    Extremely Flammable

    keep away from fire or flame
    contents under pressure
    do not puncture or incinerate container
    do not expose to temperatures above 120°F 

  • Do not use

    in or near the eyes or other mucous membranes
    in case of serious burn
    in deep puncture wounds
    for a prolonged period of time
    on large portions of the body 

  • Stop use and ask a 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

    clean the affected area
    shake can well before using
    hold can 4 to 6 inches away from injury and spray area until wet
    for adult institutional use only
    not intended for children 

  • Other Information

    avoid inhaling
    use only as directed
    intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal 

  • Inactive Ingredients

    Isopropyl Myristate, PVP-VA, SDA-40-200 Alcohol, N-Butane, Propane, Isobutane

  • Principal Display

    image description

  • INGREDIENTS AND APPEARANCE
    YOUR LOGO HERE POISON IVY FIRST AID 
    benzethonium chloride and benzocaine aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE4250 mg  in 85 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE127.5 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PVP/VA COPOLYMER (UNII: D9C330MD8B)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    ISOBUTANE (UNII: BXR49TP611)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52982-107-0385 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(52982-107)

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