XEROBURN BURN GEL (LIDOCAINE HYDROCHLORIDE) GEL [DYNAREX CORPORATION]

  • Home
  • XEROBURN BURN GEL (LIDOCAINE HYDROCHLORIDE) GEL [DYNAREX CORPORATION]

XEROBURN BURN GEL (LIDOCAINE HYDROCHLORIDE) GEL [DYNAREX CORPORATION]
PDF | XML
NDC 67777-129-00, 67777-129-01, 67777-129-02
Set ID 58985046-ca9c-12be-e053-2991aa0abe72
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
View All Sections
  • ACTIVE INGREDIENT

    Lidocaine hydrochloride 2%

  • PURPOSE

    Analgesic

  • INDICATIONS & USAGE

    ■ 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 right away.

  • DOSAGE & ADMINISTRATION

    ■ 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

  • INACTIVE INGREDIENT

    AACP, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylene glycol, Propylparaben, Purified water, Tea tree leaf oil, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IMIDUREA (UNII: M629807ATL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-129-016 in 1 BOX09/07/2017
    13.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-129-0025 in 1 BOX09/07/2017
    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)
View All Sections

Related Drugs

Search DailyMed Drugs