Label: WALG AFTRSN BURN RELIEF- lidocaine hydrochloride 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 October 5, 2017

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  • SPL UNCLASSIFIED SECTION

    Product

    WALGREENS AFTERSUN BURN RELIEF SPRAY

  • Active Ingredients

    Lidocaine Hydrochloride 0.5%

  • Purpose

    Topical Anesthetic

  • Uses:

    • Temporary relief of pain and itching
    • Helps to relieve and soothe pain from sunburn, minor burns, skin irritations, scrapes, insect bites.
  • Warnings:

    For external use only

    Do not use

    in large quantities, particularly over raw surfaces or areas with blisters.

    When using this product:

    • Avoid contact with eyes.

    Stop use and ask a doctor if:

    Keep out of reach of children.

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

  • Directions:

    • Adults and children 2 years or older: apply to affected area not more than 3-4 times daily.
    • Children under 2 years of age: do not use; ask a doctor.
  • Inactive Ingredients

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

  • Questions or comments?

    www.walgreens.com or call toll free 1-800-XXX-XXXX

  • PRINCIPAL DISPLAY PANEL

    Walgreens
    Sunburn Relief
    CONTINUOUS SPRAY
    LIDOCAINE 0.5% /
    EXTERNAL ANALGESIC
    PAIN RELIEF
    LIDOCAINE
    8 OZ (227 g)

    Walgreens Sunburn Relief CONTINUOUS SPRAY LIDOCAINE 0.5% / EXTERNAL ANALGESIC PAIN RELIEF LIDOCAINE 8 OZ (227 g)

  • INGREDIENTS AND APPEARANCE
    WALG AFTRSN BURN RELIEF 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9919
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9919-36237 mg in 1 BOTTLE; Type 0: Not a Combination Product11/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34811/30/2017
    Labeler - Walgreen Company (008965063)
    Registrant - Walgreen Company (008965063)
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