Label: XEROBURN BURN GEL- lidocaine hydrochloride gel

  • NDC Code(s): 67777-129-00, 67777-129-01, 67777-129-02, 67777-129-09, view more
    67777-129-10
  • Packager: Dynarex Corporation
  • 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 January 18, 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

    ■ Provides cooling pain relief

  • 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 15º-30ºC (59º-86ºF)

    • 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 Leaf Oil, Triethanolamine

  • Questions?

    1-888-396-2739 Monday - Friday, 9AM - 5PM EST

  • Label

    1291 BX MASTER (R170629-3)

  • INGREDIENTS AND APPEARANCE
    XEROBURN BURN GEL 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-129
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IMIDUREA (UNII: M629807ATL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-129-10600 in 1 CASE09/07/2017
    1NDC:67777-129-016 in 1 BOX
    13.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-129-09600 in 1 CASE09/07/2017
    2NDC:67777-129-0025 in 1 BOX
    23.5 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:67777-129-021728 in 1 CASE09/07/2017
    33.5 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 finalpart34809/07/2017
    Labeler - Dynarex Corporation (008124539)
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