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

  • NDC Code(s): 82749-009-01
  • Packager: Epic Medical Supply Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 4, 2024

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

  • Active Ingredients

    Lidocaine HCL 0.5% Topical Analgesic

    Benzalkonium Chloride 0.13% Topical Antiseptic

  • Purpose

    Topical Analgesic

    Topical Antiseptic

  • Uses

    For temporary relief of pain and itching associated with:

    • Sunburn
    • Minor burns,
    • Insect bites,
    • Minor skin irritation,
    • Cuts
    • Scrapes
  • Warnings

    For external use only


    Do not use

    • in the eyes 
    • over large areas of the body or on deep puncture wounds, animal bites, or serious burns 
    • in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if 

    • the condition gets worse 
    • condition clears up and recurs within a few days 
    • condition persists for more than 7 days
    • If pregnant or breast feeding, ask a health care professional before use.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage
    • Children under 2 years: consult a doctor
  • Other information

    • Store at room temperature 
    • tamper evident sealed packets 
    • do not use any opened or torn packets
  • Inactive ingredients

    Butylated Hydroxytoluene, Cetostearyl Alcohol, Dimethicone, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Macrogol Cetostearyl Ether 20, Methylcellulose, Purified Water, Sodium Methylparaben, Sodium Propylparaben.

  • Questions?

    Contact: 1.848.373.2075

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    FIRST AID BURN 
    lidocaine hydrochloride,benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82749-009
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82749-009-01144 in 1 BOX06/01/2024
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2024
    Labeler - Epic Medical Supply Corp (101423894)