LIDOSYNC

Manufacturer
Ion Pharma, LLC
Effective date
2024-09-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:51:49

Label at a glance#

ProductLIDOSYNC
Active ingredientLIDOCAINE, MENTHOL, METHYL SALICYLATE
Label structure15 sections

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredient(in each patch)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Methyl salicylate 2%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

Topical analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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).

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

​Questions or Comments:833.711.8833

  • info@ionpharmausa.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

Lidosync DiscontinuedLidosync Discontinued

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82944-102LIDOSYNC (LIDOCAINE 4%, MENTHOL 1%, METHYL SALICYLATE 2%) PATCH [ION PHARMA, LLC]2Unmatched20241020_19d17f85-8797-4447-a705-c9a15e4e361b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82944-102-10EA - Each82944-102b9ff9ba8-ad53-4f0a-ac46-18d111839def12023-07-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82944-10282944-102-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
485b5d41-d226-97b3-e063-6294a90a589f19d17f85-8797-4447-a705-c9a15e4e361b2026-01-14WarningsExact identifier
spl set id: 19d17f85-8797-4447-a705-c9a15e4e361b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.