Label: PUBLIX BURN RELIEF ALOE VERA- lidocaine hydrochloride gel

  • NDC Code(s): 56062-711-19
  • Packager: Publix Super Markets Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Lidocaine HCl   0.5%


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  • Purpose

    Topical Analgesic


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  • Uses

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


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  • 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
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  • 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.


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  • Principal Display Panel

    publix

    burn relief

    ALOEVERA GEL

    COOLS AND RELIEVES

    SUNBURN PAIN WITH LIDOCAINE

    NET WT 8 OZ(226 g)

    ZPU012A.jpg


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  • INGREDIENTS AND APPEARANCE
    PUBLIX BURN RELIEF  ALOE VERA
    lidocaine hydrochloride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:56062-711
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PROPYLENE GLYCOL  
    GLYCERIN  
    ISOPROPYL ALCOHOL  
    TROLAMINE  
    POLYSORBATE 80  
    ALOE VERA LEAF  
    MENTHOL  
    EDETATE DISODIUM  
    DIAZOLIDINYL UREA  
    FD&C YELLOW NO. 5  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:56062-711-19 226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/12/2013
    Labeler - Publix Super Markets Inc (006922009)
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