Label: PUBLIX BURN RELIEF ALOE VERA- lidocaine hydrochloride 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 July 12, 2013

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  • Active ingredient

    Lidocaine HCl   0.5%


  • Purpose

    Topical Analgesic


  • Uses

    • temporary relief of pain and itching
    • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect 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 if 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 a Poison Control Center right away


  • Directions

    • adults and children 2 years of age and older: apply to affected areas 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 Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.


  • Principal Display Panel

    publix

    burn relief

    ALOEVERA GEL

    COOLS AND RELIEVES

    SUNBURN PAIN WITH LIDOCAINE

    NET WT 8 OZ(226 g)

    ZPU012A.jpg


  • INGREDIENTS AND APPEARANCE
    PUBLIX BURN RELIEF  ALOE VERA
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-711-19226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/12/2013
    Labeler - Publix Super Markets Inc (006922009)
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