Label: BENZOCAINE AND BENZETHONIUM 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 June 21, 2016

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  • Active Ingredients

    Benzethonium Chloride 0.2% w/w

    Benzocaine 10% w/w

  • Purpose

    Topical Antiseptic

    Topical Anesthetic

  • Uses

    For temporary relief of pain, treatment and helps prevent infection in

    • minor cuts and scrapes
    • insect bites
    • minor skin irritations
  • Warnings

    For external use only

    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 mucous membranes
    • on serious burns
    • on deep puncture wounds
    • for a prolonged period of time
    • on a large portion of the body

    Stop use and ask a doctor if:

    • redness, swelling, or irritation occurs
    • infection occurs
    • condition persists or worsens
    • symptoms persists 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
    • for adult institutional use only
    • not for use on children
    • hold 4-6 inches from surface and spray area until wet
    • may be covered with sterile bandage. If bandaged, let dry first
  • Other Information

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

    Dipropylene Glycol, Isobutane, n-Butane, Propane

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    BENZOCAINE AND BENZETHONIUM 
    benzocaine and benzethonium aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-3120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE170 mg  in 85 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE8500 mg  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-3120-185 g in 1 CAN; Type 0: Not a Combination Product08/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/19/2014
    Labeler - Tender Corporation (064437304)
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