Label: LIDOSYNC- lidocaine 4%, menthol 1% patch

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

Drug Label Information

Updated January 9, 2024

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

  • Drug Facts

  • Active ingredients:

    Lidocaine 4%

    Menthol 1%

  • Purpose

    Topical anesthetic

    Topical analgesic

  • INDICATIONS & USAGE

    Uses: For temporary relief of pain.

  • Warnings

    • For external use only
  • DO NOT USE

    Do not use:

    • More than one patch on your body at a time
    • On wounds or damaged skin
    • For more than one week without consulting a doctor
    • If you are allergic to any ingredients of this product.
  • WHEN USING

    When using this product:

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

    Stop use and consult a doctor if:

    • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding: Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions: Adults, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to skin (see illustration). Apply one patch at a time to affected area, not more than 3 to 4 time 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 68 °F-77° F (20 °C-25° C.)
    • Store in a clean, dry place without direct sunlight.

  • Inactive Ingredients:

    Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrroliodone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water.

  • QUESTIONS

    ​Questions or Comments: 833.711.8833

    • info@ionpharmausa.com
  • PRINCIPAL DISPLAY PANEL

    NDC 82944-104-10

    LIDOSYNC
    Lidocaine 4% Menthol 1%

    TOPICAL PAIN PATCH
    For Temporary Pain Relief

    Flexible Patch Innovation

    Soothing and Effective
    Long Lasting Relief

    10 FLEXIBLE PATCHES
    3.94 x 5.5 (10cm x 14cm)

    ION PHARMA

    Lido

  • INGREDIENTS AND APPEARANCE
    LIDOSYNC 
    lidocaine 4%, menthol 1% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82944-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82944-104-1010 in 1 BOX10/01/2023
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2023
    Labeler - Ion Pharma, LLC (118739596)