BURN RELIEF PAIN RELIEVER WELL AT WALGREENS (LIDOCAINE 0.5%) SPRAY [WALGREENS]

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BURN RELIEF PAIN RELIEVER WELL AT WALGREENS (LIDOCAINE 0.5%) SPRAY [WALGREENS]
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NDC 0363-3107-04, 0363-3107-06
Set ID cc8d34f0-91e0-44b7-9fe4-4c31f7d98a8d
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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