Label: ULTRA LIDO GEL PATCH- lidocaine patch

  • NDC Code(s): 83035-1137-1
  • Packager: Singular Dreamer, Ltd dba True Marker
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 22, 2024

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

  • Active Ingredient                                                          Purposes

    Lidocaine 4.00% .....................................................Topical anesthetic

  • PURPOSE

  • Uses

    For temporary relief of pain.

  • Warnings

    • For External Use only

    • Do not use: ● More than 1 patch at a time ● On wounds or damaged skin ● With a heating pad ● If you are allergic to any ingredients of this product

    When using this product:

    • Use only as directed ● Avoid contact with eyes, mucous membranes or rashes ● Do not bandage tightly

    Stop use and ask a doctor if:

    • Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering ● Condition worsens
      ● Symptoms persist for more than 7 days ● Symptoms clear up and occur again within a few days
    • If pregnant or breast-feeding, ask a health professional before use.
    • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: Consult a doctor.

  • Other Information

    ● Store at controlled room temperature 20° - 25°C (68° - 77°F)
    ● Avoid storing product in direct sunlight
    ● Protect product from excessive moisture

  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycol Stearate,
    Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil,Phenoxyethanol,Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid,
    Triethanolamine.

  • SPL UNCLASSIFIED SECTION

    Questions or Comments
    Call 1-(888) 811-2634

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ULTRA LIDO GEL PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-1137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83035-1137-115 in 1 BOX07/18/2024
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/18/2024
    Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
    Registrant - Singular Dreamer, Ltd dba True Marker (129504103)