Label: FIRST AID BURN- 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 15, 2019

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  • Active Ingredient

    Lidocaine 0.5%

  • Purpose

    External analgesic

  • Use

    INDICATIONS & USAGE SECTION

    Temporarily relieves pain and itching due to:
    • Sunburn • Minor burns
    • Minor cuts • Scrapes
    • Insect bites • Minor skin irritations

    Dosage & Administration

    For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

  • Warnings

    For external use only.

    Flammable: Do not spray while smoking or near heat or flame.

  • Do not use

    Do not use in large quantities, particularly over raw surfaces or
    blistered areas.

  • When using this product:

    When using this product:
    • Keep out of eyes.
    • Use only as directed.
    • Do not puncture or incinerate. Contents under pressure. Do
    not store at temperature above 120°F.

  • Stop use and ask a doctor if:

    Stop use and ask a doctor if:
    • Condition gets worse
    • Symptoms last more than 7 days
    • Symptoms clear up and occur again in a few days

  • Keep out of reach of children.

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

  • 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: ask a doctor
    • To apply to face, spray on palm of hand and gently apply

  • Inactive Ingredients

    Water, Glycerin, Propanediol, Aloe Barbadensis Leaf Juice,
    Carbomer, Tocopheryl Acetate, PEG-40 Hydrogenated Castor Oil,
    Sodium Lauroyl Sarcosinate, Disodium EDTA, Phenoxyethanol,
    Sodium Hydroxide

  • Questions or comments?

    1-800-925-4733

  • Principal Display Panel

    Walgreens

    Compare to Solarcaine

    active ingredient

    Burn

    Relief Spray

    LIDOCAINE 0.5% /

    EXTERNAL ANALGESIC

    SPRAYS AT ANY ANGLE

    COOLING

    CONTINOUS SPRAY

    • Provides fast relief from

    cuts & scrapes, insect bites,

    minor burn & sunburn

    • Contains aloe vera

    NET WT 6 OZ (170 g)

    WALG BURN RELIEF SPRAY 6 oz.jpg

  • INGREDIENTS AND APPEARANCE
    FIRST AID BURN 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9226
    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
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9226-06170 g in 1 CAN; Type 0: Not a Combination Product01/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/15/2019
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK Piedmont LLC078482780manufacture(0363-9226)
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