YOUR LOGO HERE BURN FIRST AID (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY, METERED [DIXON INVESTMENTS, INC.]

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  • YOUR LOGO HERE BURN FIRST AID (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY, METERED [DIXON INVESTMENTS, INC.]

YOUR LOGO HERE BURN FIRST AID (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY, METERED [DIXON INVESTMENTS, INC.]
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NDC 52982-121-12, 52982-121-13
Set ID 84352da8-efd4-42d8-9284-2a795b3e3c53
Category HUMAN OTC DRUG LABEL
Packager Dixon Investments, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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