Label: LIDONEX- lidocaine hcl liquid

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

Drug Label Information

Updated February 29, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine HCL, USP 4% 

  • PURPOSE

    Purpose

    Topical Anesthetic

  • INDICATIONS & USAGE

    Use

    For temporarily relief of pain

  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame

    Do not use

    • on wounds or damaged skin
    • in large quantaties
    • 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 the eyes, mucous membranes or rashes
    • do not bandage tightly 

    Stop use and ask doctor if

    • skin reactions 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding. Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children over 12 years of age and over

    • clean and dry affected area
    • apply to affected area not more than 3 to 4 times daily

    Children under 12 years of age: Consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water, xanthan gum

  • STORAGE AND HANDLING

    • avoid storing prouct in direct sunlight
    • prodect product from excessive moisture
    • store with lid closed tightly
  • QUESTIONS

    Questions or comments? (305) 592 - 9216

  • PRINCIPAL DISPLAY PANEL

    Lidonex

  • INGREDIENTS AND APPEARANCE
    LIDONEX 
    lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73564-800
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73564-800-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/04/2022
    Labeler - Newpharma, Inc. (019170437)