BURN RELIEF (LIDOCAINE) AEROSOL, SPRAY [AMERISOURCEBERGEN DRUG CORPORATION]

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BURN RELIEF (LIDOCAINE) AEROSOL, SPRAY [AMERISOURCEBERGEN DRUG CORPORATION]
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NDC 46122-555-28
Set ID 7d898e33-ded7-c9b9-e053-2a91aa0adf7c
Category HUMAN OTC DRUG LABEL
Packager AmerisourceBergen Drug Corporation
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active Ingredients

    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.

    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. Intentional misuse by delibrately concentrating and inhaling the contents can be harmful or fatal.

    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

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

    Keep out of reach of children.

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

  • 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 (68º and 77ºF)

  • Inactive ingredients

    aloe barbadensis leaf juice, 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

    GOOD

    NEIGHBOR

    PHARMACY

    Burn Relief

    Spray

    External Analgesic

    Lidocaine 0.5%

    • Relieves pain and itching from sunburn, minor burns and insect bites
    • Cools, moisturizes and soothes sunburned skin

    NET WT 4.5 OZ (127 g)

    GNP Burn Relief Spray

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF 
    lidocaine aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-555
    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 HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPANE (UNII: T75W9911L6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-555-28127 g in 1 CAN; Type 0: Not a Combination Product10/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/25/2018
    Labeler - AmerisourceBergen Drug Corporation (007914906)
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