Label: FIRST AID ONLY FIRST AID-BURN- benzalkonium chloride, lidocaine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • Purpose

    First Aid Antiseptic

    External Analgesic

  • Uses

    First aid to help prevent infection and for the temporary relief of pain and itching associated with minor

    • cuts
    • scrapes
    • burns.
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • in large quantities, particularly over raw surfaces or blistered areas
    • if you are allergic to any of the ingredients
    • on deep puncture wounds, animal bites, or serious burns
    • more than one week unless directed by a doctor

    Keep out of reach of children.

    If swallowed contact a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply small amount 1-3 times daily
    • children under 2: consult doctor
  • Inactive ingredients

    aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

  • PRINCIPAL DISPLAY PANEL

    Packet Label Packet Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY FIRST AID-BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5702(NDC:61010-5701)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5702-000.9 g in 1 PACKET; Type 0: Not a Combination Product01/30/2023
    2NDC:0924-5702-016 in 1 CARTON12/31/2024
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5702-0210 in 1 CARTON12/31/2024
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5702-0312 in 1 CARTON12/31/2024
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5702-0420 in 1 CARTON12/31/2024
    50.9 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5702-0525 in 1 CARTON12/31/2024
    60.9 g in 1 PACKET; Type 0: Not a Combination Product
    7NDC:0924-5702-0660 in 1 CARTON12/31/2024
    70.9 g in 1 PACKET; Type 0: Not a Combination Product
    8NDC:0924-5702-07144 in 1 CARTON12/31/2024
    80.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/30/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5702) , repack(0924-5702)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5702) , repack(0924-5702)
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