Label: WALGREENS BURN RELIEF- lidocaine hydrochloride gel

  • 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 May 9, 2019

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  • Active ingredient

    Lidocaine HCl 4%......................................................................................................................... Topical analgesic

  • Uses

    Temporarily relieves pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations

  • Warnings

    For external use only

    Do Not Use

    In large quantities, particularly over raw surfaces or blistered areas

    When Using This Product

    Do not get into eyes

    Stop use and ask doctor if

    condition gets worse

    symptoms last for more than 7 days

    symptoms clear up and occur again within a few days

    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 and over: apply to affected area not more than 3 to 4 times daily

    children under 2 years: ask a doctor

  • Purpose

    Burns Relief topical analgesic

  • Other Information

    Store between 20 °C and 25 °C (68 °F and 77 °F)

  • Inactive Ingredients

    Aloe barbadensis (aloe vera) leaf juice, caprylyl glycol, chlorphensin, dimethyl isosorbide, hydroxyethyl cellulose, phenoxyethanol, propanediol, purified water, vitamin E

  • Prncipal Display Panel

    Walgreens

    Burn Gel LIDOCAINE HCl 4%

    Compare to Alocane® active ingredient††

    TOPICAL ANALGESIC

    + Vitamin E

    Maximum Strength

    + Aloe

    • Fast pain & itch relief

    • Use on sunburns & minor burns

    Burn Gel .jpg

  • INGREDIENTS AND APPEARANCE
    WALGREENS BURN RELIEF 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0290
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    WATER (UNII: 059QF0KO0R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0290-251 in 1 CARTON02/10/2018
    174 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2018
    Labeler - Walgreens (008965063)
    Registrant - Weeks & Leo, Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    weeks & Leo005290028manufacture(0363-0290)
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