Label: BURN EASE gel

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

Drug Label Information

Updated January 5, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Lidocaine Hydrochloride USP 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 persists 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 year of age and older: Apply to affected area not more than 3 to 4 times daily

    • Children under 2 years of age: Consult a doctor

  • Other Infomation

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

    • Tamper Evident. Do not use if seal is damaged.

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosscopolymer, Carbomer, Glycerin, Imidazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Oil, Trolamine

  • Questions?

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

  • Label

    FL-8610_BX_MASTER

  • INGREDIENTS AND APPEARANCE
    BURN EASE 
    burn ease gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-6210
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    IMIDUREA (UNII: M629807ATL)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-6210-1900 in 1 CASE01/08/2024
    125 in 1 BOX
    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 DrugM01701/08/2024
    Labeler - Front Line Safety (061263699)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!