Label: NORTH FIRST AID ANTISEPTIC- benzalkonium chloride, benzocaine 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 6, 2013

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  • ACTIVE INGREDIENT

    Benzethonium chloride 0.02% w/w

    Benzocaine 10% w/w

  • Purpose

    Topical antiseptic

    Topical anesthetic

  • Uses

    for temporary relief of pain and itching and helps protect against 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 120o F

    Do not use

    • in or near the eyes or other mucus membranes
    • in case of serious burns
    • in case of deep or puncture wounds
    • for prolonged period of time
    • on large portion of the body

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • condition clears up and recurs within a few days
    • redness, swelling or irritation occurs

    Keep out of the 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 4 - 6 inches from surface and spray area until wet
    • may be covered with a sterile bandage, if bandaged let dry first
    • for adult institutional use only
    • not intended for use on children
  • Other information

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

    dipropylene glycol, isobutane, n-butane, propane

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    NORTH FIRST AID ANTISEPTIC  
    benzalkonium chloride, benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0015-4085 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2013
    Labeler - North Safety Products (019777263)
    Establishment
    NameAddressID/FEIBusiness Operations
    North Safety Products019777263manufacture(0498-0015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments115315822manufacture(0498-0015)
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