Label: BURN GEL- lidocaine hci gel

  • NDC Code(s): 69396-106-09
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

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  • Active Ingredient

    Lidocaine HCL 2%

  • Purpose

    Topical Pain Relief

  • Uses

    Temporary pain relief for minor burns. For professional use only.

  • Warnings

    For external Use Only

    Do not use

    • in large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water
  • Directions

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

    Children under 2 years: do not use, consult a doctor

  • Inactive Ingredients

    Aloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate

  • Questions?

    Call 1-888-296-9067

  • Stop Use and Ask a doctor if

    The condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Storage Information

    • Store at room temperature (do not freeze)
    • 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

    4048 Globe Burn Gel 0.9g CDER

  • INGREDIENTS AND APPEARANCE
    BURN GEL 
    lidocaine hci gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-106-09144 in 1 CARTON09/27/2022
    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 DrugM01709/27/2022
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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