Label: BURN RELIEF ALOE- lidocaine hcl gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • Active ingredients                                         Purpose

    LIDOCAINE HYDROCHLORIDE               Pain Reliever

  • PURPOSE

  • Uses:

    For temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

  • Warnings For external use only

    When using this product• Avoid contact with eyes. Rinse with water if contact occurs.

    Stop use and ask doctor if• symptoms persist for more than 7 days or clear up and occur again within a few days.

    Do not usein large quantities, particularly over raw surfaces or blistered area

  • Keep out of reach of children.

  • Direction

    adults and children over 2 years and older: • Apply to affected area not more than 3-4 times a day

    • Children under 2 years old: consult a doctor

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract
    Avena Sativa (Oat) Kernel Extract
    Blue 1
    Caprylyl Glycol
    Chlorphenesin
    Dimethyl Isosorbide
    Glycerin
    Hydroxyethylcellulose
    Isopropyl Alcohol
    Phenoxyethanol
    Polysorbate 20
    Propanediol
    Tocopheryl Acetate
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF ALOE 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80551-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    OAT (UNII: Z6J799EAJK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80551-001-03113 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/18/2021
    Labeler - Acutens (051133165)
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