EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]

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EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]
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NDC 59898-140-40, 59898-200-10, 59898-200-35, 59898-200-49
Set ID 0d2631c1-93fc-478c-afed-0f175a7e8555
Category HUMAN OTC DRUG LABEL
Packager Water-Jel Technologies
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active ingredient

    Lidocaine HCl 2.0 %

  • Purpose

    External analgesic

  • Uses

    for the temporary relief of pain associated with minor burns

  • Warnings

    For external use only

    Do not use

    on large areas of the body

    on broken, blistered or oozing skin

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • conditions worsens
    • symptoms persist for more than 7 days
    • symptoms clears up and occur again in a few days

    Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
    • spread a thick even layer over affected skin
    • children under 2 years of age: consult a doctor
  • Other information

    • store at room temperature
    • do not use packeet if opened or torn
    • you may report a serious adverse reaction to this product to 800-275-3433
  • Inactive ingredients

    triethanolamine, meleleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA

  • Questions

    1-800-275-3433 www.waterjel.com

  • SPL UNCLASSIFIED SECTION

    MEDICAL DEVICES 
     2 4" x 4" Burn Dressing
     2 4" x 16" Burn Dressing
     1 8" x 18" Burn Dressing
     1 12" x 16"  Face Mask
     2 3" Rolls of Gauze
     1 Pair of Scissors
      

     

  • Principal Display Panel

    Image of PDP
  • Principal Display Panel Packet

    Burn Jel

  • Principal Display Panel

    Burn Jel

  • INGREDIENTS AND APPEARANCE
    EBSL-5 
    lidocaine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-140
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-140-401 in 1 KIT; Type 0: Not a Combination Product06/11/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 PACKET 35 mL
    Part 21 BOTTLE, PLASTIC 59 mL
    Part 1 of 2
    BURN JEL 
    lidocaine hydrochloride gel
    Product Information
    Item Code (Source)NDC:59898-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-200-4910 in 1 BOX
    1NDC:59898-200-353.5 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/11/2014
    Part 2 of 2
    BURN JEL 
    lidocaine hydrochloride gel
    Product Information
    Item Code (Source)NDC:59898-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-200-1059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/11/2014
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-140)
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