PUBLIX BURN RELIEF (LIDOCAINE HCL) GEL [PUBLIX SUPER MARKETS INC]

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PUBLIX BURN RELIEF (LIDOCAINE HCL) GEL [PUBLIX SUPER MARKETS INC]
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NDC 56062-701-16
Set ID cd3f3908-4272-4d76-8a3e-66657d17ba4c
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active ingredient

    Lidocaine HCL 0.50%
  • Purpose

    Topical Anesthetic
  • Uses

    • temporary relief of pain and itching
    • helps relieve and soothes pain from sunburn, minor burns,cuts,scrapes, skin irritations and inspect bites
  • Warnings

    For external use only

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

    When using this product

    • avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens or symptoms persist 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 Poison Control Center immediately.

  • 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: do not use, ask a doctor
  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.
  • Principal Display Panel

    Publix
    burnreilef
    ALOE VERA GEL
    COOLS AND RELIEVES
    SUNBURN PAIN WITH LIDOCAINE
    NET WT 8 OZ( 227g)
    Z02875A0.jpg

  • INGREDIENTS AND APPEARANCE
    PUBLIX BURN RELIEF  
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-701-16227 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/15/2012
    Labeler - Publix Super Markets Inc (006922009)
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