BURNRELIEF (LIDOCAINE HCL) GEL [PUBLIX]

BURNRELIEF (LIDOCAINE HCL) GEL [PUBLIX]
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NDC 56062-942-34
Set ID 9660f5e1-d39e-4f86-bf96-dff0f3bb729d
Category HUMAN OTC DRUG LABEL
Packager Publix
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active ingredient

    Lidocaine HCl

  • purpose

    External analgesic

  • Use

    for the temporary relief of pain and itching associated with

    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
  • warnings

    For external use only

  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clean 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 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
  • inactive ingredients

    water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, diazolidinyl urea, menthol, disodium EDTA, blue 1, yellow 5

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

    3300 PUBLIX CORPORATE PARKWAY

    LAKELAND, FL 33811

    publix.com

    PUBLIX GUARANTEE: COMPLETE SATISFACTION

    OR YOUR MONEY BACK

  • principal display panel

    Publix

    burnrelief

    AFTER SUN ALOE

    PAIN RELIEVING GEL

    SUNBURN RELIEF

    WITH LIDOCAINE HCl

    NET WT 8 OZ (226 g)

    image description

  • INGREDIENTS AND APPEARANCE
    BURNRELIEF 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-942
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-942-34226 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/10/2017
    Labeler - Publix (006922009)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(56062-942)

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