Label: LIDOCAINE- burn relief aerosol, spray

  • NDC Code(s): 70000-0037-1
  • Packager: LEADER/ Cardinal Health 110, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 21, 2024

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  • Active ingredient

    Lidocaine 0.5%

  • Purpose

    External analgesic

  • Uses

    for temporary relief of pain and itching associated with:

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

    For external use only.

    Flammable:

    Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately 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 clear up and occur again in a few days

    Keep out of reach of children.

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

  • Directions

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

    store between 20°C to 25°C (68° to 77°F)

  • Inactive ingredients

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

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Leader

    Burn

    Relief

    Spray

    Lidocaine 0.5%

    External Analgesic

    Relieves Pain &

    Itching from

    Sunburn, Minor

    Burns & Insect Bites

    Cools & Moisturizes

    Sunburned Skin

    NET WT 4.5 OZ (127 g)

    Burn Relief Spray

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    burn relief aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0037
    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
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPANE (UNII: T75W9911L6)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTANE (UNII: 6LV4FOR43R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0037-1127 g in 1 CAN; Type 0: Not a Combination Product02/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/15/2020
    Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)
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