Label: BURN RELIEF PAIN RELIEVER WELL AT WALGREENS- lidocaine 0.5% 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 January 30, 2018

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  • Active ingredient                            Purpose

    Lidocaine 0.5%                               External analgesic

  • SPL UNCLASSIFIED SECTION

  • Uses

    Temporarily relieves pain and itching due to

    • sunburn • minor burns • minor cuts • scrapes

    • insect bites • minor skin irritation

  • Warnings

    For external use only

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

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

    When using this product

    • keep out of your eyes
    • use only as directed
    • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F.

    Stop use and ask a doctor if

    • condition gets worse
    • symptoms last more than 7 days
    • symptoms clear up and occur again within a few days

    Keep out of reach of the children

    If swallowed, get medical help or contact a 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 into palm of hand and gently apply

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Carbomer, Diazolidinyl Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate, Triethanolamine

  • Questions and comments?

    1-866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF PAIN RELIEVER  WELL AT WALGREENS
    lidocaine 0.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3107
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3107-04170 g in 1 CAN; Type 0: Not a Combination Product03/15/2013
    2NDC:0363-3107-06227 g in 1 CAN; Type 0: Not a Combination Product03/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2013
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-3107) , label(0363-3107)
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