Label: BURN RELIEF- lidocaine hci 2.0% spray

  • NDC Code(s): 69396-107-02
  • 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 HCI 2.0%

  • Purpose

    Topical Pain Relief

  • INDICATIONS & USAGE

    Temporary pain relief associated with minor burns.

  • Warnings

    For External Use Only

  • Stop use and ask a doctor

    • If the condition worsens or persists for more than 7 days or clears up and returns.
  • Keep out of the reach of children

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

  • Do Not Use

    • In large quantities, particularly over raw or blistered areas
    • Near eyes, if this happens rinse throughly with water
  • Directions

    • Spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily.
    • Not to be used on children under 12 years of age.
  • Other information

    • Store at controlled room temperature 68º-77ºF (20º-25ºC)

  • Inactive Ingredients

    Glycerin, hydroxypropyl methylcellulose, melaleuca alternifilia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol propylene glycol, triethanolamine, water

  • Questions or Comments

    Call 1-888-296-9067

  • Distributed By:

    Trifecta Pharmaceuticals USA, LLC.

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    SKU: 4049

  • PRINCIPAL DISPLAY PANEL

    4049 Globe Burn Spray 2oz Rev08 060922 CDER

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF 
    lidocaine hci 2.0% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-107-020.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/28/2022
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)
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