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

  • 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 August 7, 2023

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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

    Adults

    • 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

    Box Label

    Box 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 BOX08/14/2023
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5702-0210 in 1 BOX08/14/2023
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5702-0312 in 1 BOX08/14/2023
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5702-0420 in 1 BOX08/14/2023
    50.9 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5702-0525 in 1 BOX08/14/2023
    60.9 g in 1 PACKET; Type 0: Not a Combination Product
    7NDC:0924-5702-0660 in 1 BOX08/14/2023
    70.9 g in 1 PACKET; Type 0: Not a Combination Product
    8NDC:0924-5702-07144 in 1 BOX08/14/2023
    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 not finalpart333A01/30/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339repack(0924-5702) , relabel(0924-5702)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5702) , repack(0924-5702)
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