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

  • NDC Code(s): 0498-0903-34
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated January 22, 2024

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  • Active ingredients

    Benzalkonium chloride 0.13%

    Lidocaine HCl 0.5%

  • Purpose

    First Aid antiseptic

    External analgesic

  • Uses

    • prevent skin infection
    • for temporary relief of pain associated with minor burns
  • Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • lin large areas of the body, particularly over raw surfaces or blistered areas
    • for more than 10 days

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days

    Keep out of reach of children

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

  • Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
  • Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
  • Inactive ingredients

    aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

  • Questions

    1-800-430-5490

  • Principal Display Panel

    First Aid Burn Cream

  • INGREDIENTS AND APPEARANCE
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0903-3410 in 1 BOX, UNIT-DOSE12/20/2017
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/20/2017
    Labeler - Honeywell Safety Products USA, Inc (118768815)
    Registrant - Honeywell Safety Products USA, Inc (118768815)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0903)
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