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

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

Drug Label Information

Updated November 17, 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

    • 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 reach of children.

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

  • 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

  • OTHER INFORMATION

    Store in a cool dry area 150 – 250C (590 – 770F)

  • INACTIVE INGREDIENTS

    butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium

  • QUESTIONS

    Questions 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    carton label Carton Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY FIRST AID/BURN 
    lidocaine hydrochloride and benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5011(NDC:50382-022)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5011-000.9 g in 1 PACKET; Type 0: Not a Combination Product08/30/2021
    2NDC:0924-5011-0212 in 1 CARTON08/30/2021
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5011-0325 in 1 CARTON08/30/2021
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5011-0110 in 1 CARTON08/30/2021
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5011-04144 in 1 CARTON08/30/2021
    50.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/30/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5011) , repack(0924-5011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5011) , repack(0924-5011)
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