Label: BURN RELIEF ALOE VERA GEL GNP- lidocaine hl 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

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  • Active ingredients                                 Purpose

    Lidocaine Hydrochloride 0.5% ............. External Analgesic

  • PURPOSE

  • Uses

    For the 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.
    Do not use in large quantities, particularly over raw surfaces or blistered areas.
    Stop use and ask doctor if • symptoms persist for more than 7 days, or 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 immediately.

  • Directions


    • Adults and children 2 years and older: apply to affected area not more than 3 - 4 times a day.
    • Children under 2 years of age: consult a physician.

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, lsopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

  • Questions or comments?

    888-793-8450

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF ALOE VERA GEL   GNP
    lidocaine hl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-654
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-654-34237 mL in 1 CONTAINER; Type 0: Not a Combination Product01/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/15/2021
    Labeler - Amerisource Bergen (007914906)
    Registrant - Inspec Solutions LLC (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC081030372manufacture(46122-654)
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