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

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

Drug Label Information

Updated October 9, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    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 at room temperature

  • Inactive Ingredients

    butylated hydroxytoluene, cetostearyl alcohol, dimethicone, edetate sodium, glycerin, glyceryl monostearate, isopropyl myristate, macrogol cetostearyl ether 20, methylcellulose, purified water, sodium methylparaben, sodium propylparaben

  • Questions

    1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Carton Label Carton Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY FIRST AID/BURN 
    lidocaine hydrochloride, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5730(NDC:61040-007)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5730-000.9 g in 1 PACKET; Type 0: Not a Combination Product10/16/2023
    2NDC:0924-5730-0212 in 1 CARTON10/16/2023
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5730-0325 in 1 CARTON10/16/2023
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/16/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5730) , repack(0924-5730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599repack(0924-5730) , relabel(0924-5730)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!