Label: SUNBURNT PLUS- lidocaine hydrochloride gel

  • NDC Code(s): 68229-601-01, 68229-601-02
  • Packager: Quest Products, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine Hydrochloride 4%

  • Purpose

    Topical Pain Relief

  • Uses

    Temporarily relieves pain and itching due to:

    • sunburn
    • minor burns
    • insect bites
    • minor skin irritations
    • minor cuts
    • scrapes
  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas
    • if you have an allergy or hypersensitivity to any ingredients

    Ask a doctor before use if

    • you have severe sunburn
    • you have a rash or broken or compromised skin

    When using this product

    • Avoid contact with eyes

    Stop use and ask a doctor

    • condition worsens
    • symptoms last 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 right away.

  • Directions

    • clean skin and apply to affected area
    • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
    • children under 2 years of age: ask a doctor
  • Other Information

    • store at 15-30°C (59-86°F)
    • do not use if seal under cap is open or missing
  • Inactive Ingredients

    Water, Hydroxyethylcellulose,Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Juice, D-Panthenol, Calunda Officinalis Extract, Echinacea Purpurea Root Extract, Mannitol, Sodium Hyaluronate, Lactobacillus Ferment, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL - 118mL Tube Carton

    PDP

  • INGREDIENTS AND APPEARANCE
    SUNBURNT PLUS 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-601-021 in 1 CARTON02/23/2024
    1NDC:68229-601-01118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/23/2024
    Labeler - Quest Products, LLC. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855manufacture(68229-601)
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