WALG AFTRSN BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]

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WALG AFTRSN BURN RELIEF (LIDOCAINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]
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NDC 0363-9919-36
Set ID de3e40b5-0c2d-45d6-a8fb-17e9a1041c0e
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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