Label: BURN EASE 3.5G gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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  • Active Ingredient

    Lidocaine Hydrochloride 2%

  • Purpose

    Analgesic

  • Use(s)

    • For the temporary relief of pain associated with • Minor burns • Sunburn

  • Warnings

    For External Use Only

    Do not use

    • On wounds or damaged skin

    • In large quantities, particularly over raw surfaces or blistered areas

    When using this product

    • Avoid contact with the eyes • Do not bandage tightly

    Stop use and ask a doctor if

    • Condition worsens • Symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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 year of age: Consult a doctor

  • Other Information

    • Store at room temperature

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Imidazolidinly Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

  • Questions?

    1-888-900-2920 Monday - Friday 8AM-4PM PST

  • Label

    FL-3831_BX_MASTERFL-3831

  • INGREDIENTS AND APPEARANCE
    BURN EASE 3.5G 
    burn ease 3.5g gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-6231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    IMIDUREA (UNII: M629807ATL)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-6231-1480 in 1 CASE01/26/2024
    120 in 1 BOX
    13.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/26/2024
    Labeler - Front Line Safety (061263699)
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