Label: PUBLIX BURN RELIEF- lidocaine hcl 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 November 15, 2012

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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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