Label: LIDOCAINE- burn relief spray aerosol, spray

  • NDC Code(s): 56104-006-45
  • Packager: Premier Brands of America Inc.
  • 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 November 14, 2019

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

  • Active ingredient

    Lidocaine 0.5%

  • ​ ​Purpose

    External analgesic

  • Uses

    for the temporary relief of pain and itching associated with:

    • sunburn
    • minor burns
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
  • Warnings

    For external use only.​ Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    ​Flammable:

    Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

    ​Do not use

    in large quantities, particularly over raw surfaces or blistered areas.

    When using this product

    • do not get into eyes
    • ask a doctor before using on children under 2 years of age

    ​Stop use and ask a doctor if

    • conditions gets worse
    • symptoms last more than 7 days or clears up and occurs again in few days

    ​Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

  • ​Directions

    • shake can well
    • for adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily
    • for children under 2 years of age, ask a doctor
    • to apply to face spray in palm of hand and gently apply
  • ​Other information

    store between 20º and 25ºC (68ºF and 77º)

  • ​Inactive ingredients

    aloe barbadensis gel, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, tocopheryl acetate (vitamin E acetate), triethanolamine, simethicone, water

  • ​ ​Questions?

    call 1-866-964-0939

  • ​Principal Display Panel

    Premier

    Burn Relief Spray

    with Aloe

    Cool and soothes

    Relieves pain with lidocaine

    For minor burns, cuts and scrapes

    Cools, moisturizes and relieves itching

    Net WT 4.5 OZ (127 g)

    PB Burn Relief.jpg

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    burn relief spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.64 g  in 127 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTANE (UNII: 6LV4FOR43R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPANE (UNII: T75W9911L6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-006-45127 g in 1 CANISTER; Type 1: Convenience Kit of Co-Package01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2013
    Labeler - Premier Brands of America Inc. (080051232)