Label: BURN CREAM- benzalkonium chloride, lidocaine hci cream

  • NDC Code(s): 69396-124-09
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 July 17, 2023

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  • Active Ingredient

    Lidocaine HCI 0.5%

  • Purpose

    Topical Analgesic

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • Purpose

    First Aid Antiseptic

  • Uses

    Temporary Relief of pain associated with minor cuts, scrapes and burns.

    Helps protect against harmful bacteria.

  • Warnings

    For external Use Only

    Do not use

    • in eyes
    • in large quantities
    • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
    • for more than one week unless directed by a doctor
  • Directions

    • Clean the affected area
    • Apply a small amount not more than 3 times daily
    • May be covered with a sterile bandage
  • Inactive Ingredients

    Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, purified water, stearic acid, Triethanolamine.

  • Questions

    To reorder:

    Call 1-760-642-2638

  • Storage Information

    • Store in cool dry area 15° to 25°C (59° to 79°F).
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • Keep out of reach of children

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

  • Other Information

    Manufactured for:

    Urgent First Aid®

    2603 Industry Street

    Oceanside, CA. 92054 USA

    www.UrgentFirstAid.com

    Reorder # URG-400

  • PRINCIPAL DISPLAY PANEL

    URG-400 BURN CREAM 0.9G 25PK 032023 CDER

  • INGREDIENTS AND APPEARANCE
    BURN CREAM 
    benzalkonium chloride, lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-124-0925 in 1 CARTON03/02/2023
    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 not finalpart34803/02/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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