Label: BURN CREAM- benzalkonium chloride, lidocaine hci cream

  • NDC Code(s): 69396-146-10, 69396-146-25
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • Active Ingredient

    Lidocaine HCL 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

    Call: 1-888-296-9067

  • 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

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Ave. Ste 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • PRINCIPAL DISPLAY PANEL

    R519-541 GLOBE FIRST AID BURN CREAM 0.9G 25PK 112823 CDER

  • PRINCIPAL DISPLAY PANEL

    R519-539 GLOBE FIRST AID BURN CREAM 0.9G 10CT 112823 CDER

  • INGREDIENTS AND APPEARANCE
    BURN CREAM 
    benzalkonium chloride, lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-146
    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
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-146-1010 in 1 CARTON03/06/2024
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69396-146-2525 in 1 CARTON03/06/2024
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/06/2024
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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