Label: ANTISEPTIC- benzalkonium chloride, benzocaine spray

  • NDC Code(s): 61010-5300-0, 61010-5300-2
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.1%

    Benzocaine 5.0%

  • Purpose

    First Aid Antiseptic

    Topical Pain Relief

  • Uses

    First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

  • Warnings

    For external use only. Flammable keep away from fire or flame.

    Do not use

    • near eyes or mucous membranes
    • on deep or puncture wounds, animal bites, or serious burns
    • over large areas of the body
    • more than one week unless directed by a doctor

    Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away.

    Stop use and ask doctor ifcondition persists or gets worse

  • Directions

    • clean affected and spray 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 ask a doctor.
  • Inactive ingredients

    isopropyl alcohol, purified water

  • PRINCIPAL DISPLAY PANEL – bottle label

    NDC 61010-5300-0

    Safetec

    Cut & Scrape
    Antiseptic Spray

    For Temporary Pain
    Relief and to Help
    Prevent Infection in
    Minor Cuts, Scrapes
    and Abrasions.

    2 fl. oz. (59.1ml)
    Reorder no. 53000

    PRINCIPAL DISPLAY PANEL – bottle label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride, benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5300-290 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/15/2012
    2NDC:61010-5300-060 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/15/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-5300)
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