Label: FIRST AID BURN- lidocaine hydrochloride 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 October 7, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief for 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 Poison Control Center right away

  • Directions

    • for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
    • for children under 2 years of age consult a physician
  • Inactive ingredients

    aloe vera, germaben II, propylene glycol, purified water

  • Questions?

    call 1-800-480-5855

  • Principal Display Panel - 59.1 mL Bottle Label

    UniShield

    FIRST AID
    BURN
    SPRAY

    For Temporary
    Pain Relief of
    Minor Burns

    NET CONTENTS 2 FL.OZ. (59.1 ML)

    Distributed by: UniShield, San Fernando, CA 91340
    Made in USA

    Principal Display Panel - 59.1 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID BURN 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-5100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-5100-459.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/07/2019
    Labeler - Unishield (790677053)
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