Label: LIDOSYNC- lidocaine 4%, menthol 1%, methyl salicylate 2% patch

  • 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 May 24, 2023

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

  • Drug Facts

  • Active Ingredient(in each patch)

    Lidocaine 4%

    Menthol 1%

    Methyl salicylate 2%

  • Purpose

    Topical anesthetic

    Topical analgesic

    Topical analgesic

  • INDICATIONS & USAGE

    Uses: Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

    • muscle soreness
    • strains
    • sprains
    • arthritis
    • simple backache
    • muscle stiffness
    • bruises
  • Warnings

    For external use only

  • SPL UNCLASSIFIED SECTION

    Stomach bleeding warning: This product contains a NSAID, which may cause stomach bleeding. The chance is small.but higher if you

    • are aged 60 or older
    • have had stomach ulcers or bleeding problems
    • take other drugs containing an NSAID (Aspirin,Ibuprofen, Naproxen, or others)
    • take a blood thinning (anticoagulant) or steroidal drug
    • have three or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed.
  • DO NOT USE

    Do not use

    • More than one patch on your body at a time
    • On cut, irritated or swollen skin
    • On puncture wounds
    • If you are allergic to any active or inactive ingredients
    • If pouch is damaged or opened.
  • WHEN USING

    When using this product

    • Use only as directed
    • Read and follow all directions and warnings
    • Do not allow to contact with the eyes
    • Do not use at the same time as other topical analgesics
    • Do not bandage tightly or apply local heat(such as heating pads)to the area of use
    • Do not microwave
    • Dispose of used patch in manner that always keeps product away from children and pets.Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • STOP USE

    Stop use and consult a doctor if

    • Condition worsens
    • Redness is present
    • Irritation develops
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
    • Stomach pain or upset gets worse or lasts
    • You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding).
  • 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.

  • Directions

    Adults, or children over the age of 12:Clean and dry affected area.

    Apply sticky side of patch to affected area and leave in place for 8 hours.If pain lasts after using the first patch, a second patch may be applied. Only use one patch at a time. do not use more than 2 patches per day. Wash hands with soap and water after applying or removing patch. Reseal pouch containing unused patches immediately after each use. Children under 12 years of age: Do not use.

  • Other information

    • Store at 68°F-77°F (20 °C-25°C).
    • Store in a clean, dry place without direct sunlight. Protect from excessive moisture.
    • Some individuals may not experience pain relief until several minutes or hours after applying the patch.

  • Inactive Ingredients

    Arnica Montana Flower Extract, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-tartaric Acid, Mineral Oil, Polyacrylic Acid, Propylene Glycol, Polysorbate 80, PVP, Sodium Polyacrylate, Titanium Dioxide, Water.

  • QUESTIONS

    ​Questions or Comments: 833.711.8833

    • info@ionpharmausa.com
  • PRINCIPAL DISPLAY PANEL

    NDC 82944-102-10

    LIDOSYNC
    Lidocaine 4%, Menthol 1%, Methyl Salicylate 2%

    TOPICAL PAIN PATCH
    For Temporary Pain Relief

    Flexible Patch Innovation

    Soothing and Effective
    Long Lasting Relief

    Qty: 10 Flexible Patches

    (5 per Resealable Pouch) x2

    3.94 x 5.5 (10cm x 14cm)

    ION PHARMA

    Lido

  • INGREDIENTS AND APPEARANCE
    LIDOSYNC 
    lidocaine 4%, menthol 1%, methyl salicylate 2% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82944-102
    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
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    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)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82944-102-1010 in 1 BOX06/01/2023
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2023
    Labeler - Ion Pharma, LLC (118739596)