Label: FSK-5- lidocaine hydrochloride kit

  • NDC Code(s): 59898-170-43, 59898-200-15, 59898-200-35
  • Packager: Water-Jel Technologies
  • 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 December 7, 2017

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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 2" x 6" Burn Dressings
     2 4" x 4" Burn Dressings
     112" x 16" Face Mask
     1 2" x 2.2 yd Elastic Bandage

     

  • Principal Display Panel

    image of PDP

  • Principal Display Panel Packet

    Burn Jel

  • INGREDIENTS AND APPEARANCE
    FSK-5 
    lidocaine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-170
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-170-431 in 1 KIT06/11/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 125 PACKET 87.5 mL
    Part 1 of 1
    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:59898-200-1525 in 1 CARTON
    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
    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(59898-170)
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