Label: YOUR LOGO HERE BURN FIRST AID- benzalkonium chloride and benzocaine spray, metered

  • 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 8, 2013

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  • Active Ingredients

    Benzalkonium Chloride 0.14%
    Benzocaine 5.0% 

  • Purpose

    Topical Antiseptic
    Topical Anesthetic 

  • Uses

    Treatment of minor cuts
    Pain relief
    Helps prevent infection 

  • Warnings

    For external use only

  • Do not use

    in eyes or near mucous membranes
    For serious burns
    For prolonged period of time 

  • Stop use and ask a doctor if

    Irritation, redness, or swelling increases
    Rash or infection occurs 

  • Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away

  • Directions

    Hold 4-6 inches from surface
    Spray area until wet 

  • Inactive Ingredients

    Aloe Vera Gel, Isopropyl Alcohol, Menthol, Propylene Glycol, Water 

  • Principal Display

    image description

  • INGREDIENTS AND APPEARANCE
    YOUR LOGO HERE BURN FIRST AID 
    benzalkonium chloride and benzocaine spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE3825 mg  in 90 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE107.1 mg  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52982-121-1390 mL in 1 BOTTLE, SPRAY
    2NDC:52982-121-1259 mL 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(52982-121)
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