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 December 22, 2020

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  • 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

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns

    When using this product

    avoid contact with eyes

    Stop use and ask a doctor if

    ▪condition worsens or clears up and occurs again within a few days

    ▪symptoms persist for more than 7 days

    ▪a rash or allergic reaction occurs

    Keep out of the reach of children.

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

  • Other information

    Store at room temperature

  • Directions

    Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily.

    Children under 2- Consult a doctor

  • Inactive ingredients

    aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, triethanolamine

  • Questions?

    1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    Carton ImageCarton Image

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY FIRST AID/ BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5711(NDC:59898-902)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5711-0410 in 1 CARTON04/08/2019
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5711-026 in 1 CARTON04/08/2019
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5711-036 in 1 BAG04/08/2019
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5711-010.9 g in 1 PACKET; Type 0: Not a Combination Product04/08/2019
    5NDC:0924-5711-0510 in 1 CARTON04/08/2019
    50.9 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5711-0612 in 1 CARTON04/08/2019
    60.9 g in 1 PACKET; Type 0: Not a Combination Product
    7NDC:0924-5711-0720 in 1 CARTON04/08/2019
    70.9 g in 1 PACKET; Type 0: Not a Combination Product
    8NDC:0924-5711-0820 in 1 CARTON04/08/2019
    80.9 g in 1 PACKET; Type 0: Not a Combination Product
    9NDC:0924-5711-0925 in 1 CARTON04/08/2019
    90.9 g in 1 PACKET; Type 0: Not a Combination Product
    10NDC:0924-5711-1025 in 1 CARTON04/08/2019
    100.9 g in 1 PACKET; Type 0: Not a Combination Product
    11NDC:0924-5711-1150 in 1 CARTON04/08/2019
    110.9 g in 1 PACKET; Type 0: Not a Combination Product
    12NDC:0924-5711-1260 in 1 CARTON04/08/2019
    120.9 g in 1 PACKET; Type 0: Not a Combination Product
    13NDC:0924-5711-13144 in 1 CARTON04/08/2019
    130.9 g in 1 PACKET; Type 0: Not a Combination Product
    14NDC:0924-5711-14144 in 1 CARTON04/08/2019
    140.9 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 finalpart34804/08/2019
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5711) , repack(0924-5711)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5711) , repack(0924-5711)
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