Label: YOUR LOGO HERE POISON IVY FIRST AID- benzethonium chloride and benzocaine 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 April 9, 2013

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  • 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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