Label: BURN JEL- lidocaine hydrochloride gel

  • NDC Code(s): 59898-200-10, 59898-200-11, 59898-200-12, 59898-200-13, view more
    59898-200-15, 59898-200-16, 59898-200-17, 59898-200-35, 59898-200-49
  • 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 January 2, 2023

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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
    • condition clears up and occurs again within 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
    • you may report a serious adverse reaction to this product to 800-275-3433
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate, carbomer, diazolidinyl urea, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, triethanolamine, water

  • Questions or comments?

    1-800-275-3433 info@waterjel.com www.waterjel.com
    Manufactered by Water-Jel Technologies, Inc., 50 Broad Street,
    Carlstadt, NJ 07072, USA

  • Principal Display Panel

    Principal Display LabelBJ2RDBJ4RD

  • INGREDIENTS AND APPEARANCE
    BURN JEL 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem 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:59898-200-1324 in 1 CARTON04/17/2010
    1NDC:59898-200-12118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59898-200-166 in 1 BOX04/17/2010
    23.5 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:59898-200-1124 in 1 CARTON04/17/2010
    3NDC:59898-200-1059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:59898-200-171728 in 1 CARTON04/17/2010
    43.5 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:59898-200-353.5 mL in 1 PACKET; Type 0: Not a Combination Product04/17/2010
    6NDC:59898-200-1525 in 1 BOX04/17/2010
    63.5 mL in 1 PACKET; Type 0: Not a Combination Product
    7NDC:59898-200-4910 in 1 KIT04/17/2010
    73.5 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 finalpart34804/17/2010
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-200)
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