Label: BURN RELIEF ALOE- 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 January 17, 2022

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

  • 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 use in 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 not finalpart34803/18/2021
    Labeler - Acutens (051133165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions081030372manufacture(80551-001)