Label: BURN RELIEF- lidocaine 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 July 23, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                     Purpose
    Lidocaine 0.5%.........................External analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of pain and itching associated with: • sunburn
    • minor burns • minor cuts • scrapes • insect bites • minor skin irritations

  • WARNINGS

    Warnings
    For external use only.
    Flammable: Do not use near heat, flame, or while smoking.
    Do not use in large quantities, particularly over raw surfaces or blistered areas.
    When using this product • keep away from face to avoid breathing it. • avoid
    contact with eyes. • use only as directed. • do not puncture or incinerate.
    Contents under pressure. Do not store at temperatures above 120ºF.
    If condition worsens or if symptoms persist for more than 7 days or clear up and
    occur again within a few days, discontinue use of this product and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Shake well • 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 • Do not spray directly into face; spray into palm of hand and
    gently apply

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl
    Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben,
    Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate,
    Triethanolamine.

  • Questions? 610-727-7000

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-777-04128 g in 1 CAN; Type 0: Not a Combination Product03/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2012
    Labeler - Amerisource Bergen (007914906)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(24385-777) , label(24385-777)