Label: BURNX PAIN RELIEVING BURN- lidocaine hydrochloride gel

  • 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 October 24, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine hydrochloride 2.5%

  • Purpose

    Topical analgesic

  • Use

    for the temporary relief of pain associated with minor burns, sunburn, and minor skin irritations

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Not for prolonged use.

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
    • rash or irritation develops, persists, or increases

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • 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 15 to 30° C (59 to 86° F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive Ingredients

    Carbomer, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, octoxynol-9, propylene glycol (and) diazolidinyl urea (and) methylparaben (and) propylparaben, purified water, triethanolamine

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Natureplex™

    PAIN RELIEVING BURN GEL
    NDC 67234-037-01

    BurnX™
    LIDOCAINE HCL 2.5%
    Topical Analgesic

    For Burns and
    Sunburns

    NET WT. 1 Oz.(28g)

    Principal Display Panel - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BURNX   PAIN RELIEVING BURN
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-037-011 in 1 CARTON04/10/2010
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34804/10/2010
    Labeler - Natureplex, LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-037)
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