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Leader PAIN RELIEF PATCHES

lidocaine · Leader PAIN RELIEF PATCHES is an amide local anesthetic (over-the-counter) containing lidocaine, made by Cardinal Health, 110 dba LEADER.

Type
Over the counter
Drug class
Amide Local Anesthetic
Route
Topical
Manufacturers
1

Uses: Temporaily relieves minor pains.

Drug facts

Generic name
lidocaine
Active ingredients
Lidocaine
Drug class
Amide Local AnestheticAntiarrhythmic
Dosage forms
Patch
Label holder
Cardinal Health, 110 dba LEADER
FDA application
M017
Label updated
12/08/2025

Active ingredients

Lidocaine 4%.............................. Topical Anesthetic

Purpose

Temporarily relieves minor pain.

Uses

Uses: Temporaily relieves minor pains.

Directions

Directions Adults and children over 12 years:

  • Clean and dry affected area
  • Remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • Once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • Use one patch for up to 12 hours. Children under 12 years of age: consult a physician.

Warnings

For external use only.

Do not use

  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened.

When using this product

  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not allow 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 and ask a doctor

Stop use and consult a doctor

  • 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.

Pregnancy or breastfeeding

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

Keep out of reach of children

And pets. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions?

TOLL-FREE Customer Care Help Line 866-326-1313 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 Made in China

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Patch4 g/100gtopical2

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

Pharmacies paid about $1.08 per tablet, capsule or unit across 2 package codes.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 57,975 reports that list lidocaine, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective4,341
  • Off label use4,128
  • Pain3,661
  • Fatigue3,499
  • Product adhesion issue3,452
  • Nausea3,399
  • Headache3,310
  • Product quality issue3,206
  • Sinusitis2,562
  • Dyspnea2,402

To report a side effect, use FDA MedWatch.

Manufacturers and labels

2 FDA labels

  • Cardinal Health, 110 dba LEADERShown hereM017 · Label 12/08/2025 · NDC 70000-0557Full label
  • Cardinal Health, 110 dba LEADERM017 · Label 12/08/2025 · NDC 70000-0366Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Leader PAIN RELIEF PATCHES: common questions

What is Leader PAIN RELIEF PATCHES used for?
Uses: Temporaily relieves minor pains.
Is Leader PAIN RELIEF PATCHES a prescription drug?
No. Leader PAIN RELIEF PATCHES is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Leader PAIN RELIEF PATCHES?
Yes. Other FDA-listed products with the same active ingredients include Pain Relief Patches, Burn Relief, LIDOCAINE PAIN RELIEF Gel-Patch, Lidocaine Numbing Cream.
Who makes Leader PAIN RELIEF PATCHES?
Cardinal Health, 110 dba LEADER lists Leader PAIN RELIEF PATCHES with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/08/2025 · Label text is shown as published by the manufacturer. Not medical advice