Label: BURN MIST- lidocaine hydrochloride spray

  • NDC Code(s): 59898-201-10
  • 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 21, 2020

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  • Active ingredient

    Lidocaine HCl 2%

  • Purpose

    External analgesic

  • Uses

    for the temporary relief of pain associated with minor burns

  • Warnings

    For external use only

    Do not use

    in large quantities, particularly over raw surfaces or blistered areas

    When using this product

    avoid contact with eyes

    • condition 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.

  • 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
  • Other information

    store at room temperature

    you may report a serious adverse reaction to this product to 1-800-275-3433

  • Inactive ingredients

    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, tea tree oil, trolamine, 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

    BS2

  • INGREDIENTS AND APPEARANCE
    BURN MIST 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-201
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-201-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/17/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/17/2010
    Labeler - Water-Jel Technologies (155522589)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-201)
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