BURNX PAIN RELIEVING BURN (LIDOCAINE HYDROCHLORIDE) GEL [NATUREPLEX, LLC]

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BURNX PAIN RELIEVING BURN (LIDOCAINE HYDROCHLORIDE) GEL [NATUREPLEX, LLC]
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NDC 67234-037-01
Set ID 0558cdc9-8523-4dd5-baa5-9a8b0af46f8c
Category HUMAN OTC DRUG LABEL
Packager Natureplex, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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