Label: UNISHIELD FIRST AID BURN- lidocaine hcl spray

  • 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 March 18, 2023

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  • Active ingredient

    Lidocaine HCL 2.0%

  • Purpose

    .Topical pain relief

  • Uses

    Temporary pain relief associated with minor burns

  • Warnings

    For external use only

  • Do not use

    • in large quantities, particularly over raw or blistered areas.
    • near eyes, if this happens rinse thoroughly with water
  • Stop use and ask a doctor

    if condition worsens or persists for more than 7 days or clears up and returns.

  • Keep out of reach of children.

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

  • Directions

    • spray an over layer of burn spray over cleaned affected area not more than 3-4 times daily
    • not to be used on children under 12 years of age
  • Inactive ingredients

    glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

  • Questions or comments？

    1-800-480-5855

  • Package Label - Principal Display Panel

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    UNISHIELD FIRST AID BURN 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-0002-159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/20/2023
    Labeler - Unishield (790677053)
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