Label: BURN EASE gel

  • NDC Code(s): 58228-3832-1, 58228-3832-2
  • Packager: ProStat First Aid LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 17, 2023

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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 years of age: Consult a doctor

  • Other Information

    • Store at room temperature

  • Inactive Ingredients

    Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Proplyene glycol, Propylparaben, Purified water, Tea tree leaf oil, Triethanolamine

  • Questions?

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

  • Label

    PS-3832-BX-MASTERBurn Ease

  • INGREDIENTS AND APPEARANCE
    BURN EASE 
    burn ease gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-3832
    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
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    IMIDUREA (UNII: M629807ATL)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-3832-2600 in 1 CASE04/10/2023
    1NDC:58228-3832-16 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 not finalpart34804/10/2023
    Labeler - ProStat First Aid LLC (061263699)
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