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Lidocare 03

4% lidocaine · Lidocare 03 is an amide local anesthetic (over-the-counter) containing 4% lidocaine, made by Kingsway Pharmaceuticals dba NFI, LLC.

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

For the temporary relief of pain.

Drug facts

Generic name
4% lidocaine
Active ingredients
Lidocaine
Drug class
Amide Local AnestheticAntiarrhythmic
Dosage forms
Patch
Label holder
Kingsway Pharmaceuticals dba NFI, LLC
FDA application
M017
Label updated
01/06/2025

Active ingredients

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For the temporary relief of pain.

Directions

Adults and children over 12 years of age: Apply patch to affected area every 8 to 12 hours. Children 12 years or younger: Consult a physician before use. Instructions for Use

  • Clean and dry affected area
  • Cut open pouch and remove the patch
  • Remove clear protective liner from the patch
  • Apply to affected area no more than three (3) times per day
  • Leave in place for up to 8 but no more than 12 hours
  • Wash hands thoroughly after applying or removing patch
  • Some individuals may not experience pain relief until several minutes or hours after applying a patch
  • Do not use other local anesthetic products in addition to Lidocare. Storage Information
  • Protect from freezing or excessive heat
  • Store at 68°-77°F (20°-25°C).

Warnings

For external use only. Do not use if pouch is damaged or opened. Do not use

  • On large areas of the body or on cut, irritated skin
  • On open wounds or sensitive skin
  • For more than one week without consulting a doctor
  • Do not use if you are allergic to lidocaine or any of the inactive ingredients listed below. When using this product
  • Use only as directed. Read and follow all directions and warnings on this package.
  • Do not allow contact with the eyes
  • Do not bandage or apply local heat (such as heating pads) to the area of use
  • Do not reuse patch. Stop use and ask doctor if
  • Condition worsens
  • Rash, itching or skin irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away.

Do not use

If pouch is damaged or opened. Do not use

  • On large areas of the body or on cut, irritated skin
  • On open wounds or sensitive skin
  • For more than one week without consulting a doctor
  • Do not use if you are allergic to lidocaine or any of the inactive ingredients listed below.

When using this product

  • Use only as directed. Read and follow all directions and warnings on this package.
  • Do not allow contact with the eyes
  • Do not bandage or apply local heat (such as heating pads) to the area of use
  • Do not reuse patch.

Stop use and ask a doctor

Stop use and ask doctor if

  • Condition worsens
  • Rash, itching or skin irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

Pregnancy or breastfeeding

Ask a health professional before use.

Keep out of reach of children

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

Other information

Storage Information

  • Protect from freezing or excessive heat
  • Store at 68°-77°F (20°-25°C).

Inactive ingredients

Crospovidone, menthoxypropanediol, non-woven backing fabric, polyester film, non-latex rubber based adhesive, vanillyl butyl ether.

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Patch4 gtopical1

Manufacturers and labels

1 FDA label

  • Kingsway Pharmaceuticals dba NFI, LLCShown hereM017 · Label 01/06/2025 · NDC 69993-400Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Lidocare 03: common questions

What is Lidocare 03 used for?
For the temporary relief of pain.
Is Lidocare 03 a prescription drug?
No. Lidocare 03 is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Lidocare 03?
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 Lidocare 03?
Kingsway Pharmaceuticals dba NFI, LLC lists Lidocare 03 with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/06/2025 · Label text is shown as published by the manufacturer. Not medical advice