SPL v4
SPL
SPL Set ID 3ce4af20-b227-5b98-e063-6394a90ab992
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Pvp Glycerin Propylparaben Titanium Dioxide Water Tartaric Acid Polysorbate 80 Propylene Glycol Sodium Polyacrylate (2500000 Mw) Dihydroxyaluminum Aminoacetate Polyacrylic Acid (8000 Mw) Methylparaben Kaolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Lidocaine 4%


Medication Information

Description

Lidocaine 4%

Uses

Temporarily relieves minor aches and pains

Section 43683-2

image of packaging uploaded

Warnings

For external use only

Directions

Adults and children over 12 years:

  • Clean and dry the affected area
  • Remove the protective film by firmly grasping both ends and gently puling until it separate in the middle
  • Carefully peel back part of the protective film and apply the exposed part of the patch to the affected area
  • Remove the remaining film while pressing the patch firmly to the skin
  • Use 1 patch for up to 8 hours

Children 12 years and under: Ask a doctor

Do Not Use:
  • More than 1 patch on your body at a time
  • On wounds, damaged, irritated or swollen skin
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
Administration

Remove patch from outer package.

Partially peel back protective film.

Place on affected area.

Remove remaining film while pressing patch to skin.

Active Ingredient

Lidocaine 4%

Other Information

Store at room temperature (20-25 C / 68-77 F)

Inactive Ingredients

Glycerin, Sodium polyacrylate, Water, Methylparaben, Propylparaben, Dihydroxyaluminum aminoacetate, Tartaric acid, PVP, Polysorbate 80, Kaolin, Titanium Dioxide, Propylene glycol, Polyacrylic acid

Questions Or Comments

864-432-4006 [email protected]

When Using This Product:
  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do not bandage tightly or apply local heat (such as heating pads) to the area
  • Do not use with other topical analgesics at the same time
  • Dispose of used patches safely, always keeping them away from children and pets
  • Used patches still contain medication that can cause serious harm if chewed or ingested
  • A temporary burning sensation may occur upon application but usually goes away in a few days
  • If a severe burning sensation occurs, stop use immediately
If Pregnant Or Breastfeeding

Ask a healthcare professional before use

Stop Use and Ask A Doctor If:
  • Condition worsens
  • You experience signs of skin injury, such as redness, irritation, pain, swelling, or blistering where the product was applied
  • Symptoms persist for more than 7 days, or clear up and return within a few days
4% Lidocaine Pain Relief Gel Patch

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Uses

Temporarily relieves minor aches and pains

Section 43683-2 (43683-2)

image of packaging uploaded

Warnings

For external use only

Directions

Adults and children over 12 years:

  • Clean and dry the affected area
  • Remove the protective film by firmly grasping both ends and gently puling until it separate in the middle
  • Carefully peel back part of the protective film and apply the exposed part of the patch to the affected area
  • Remove the remaining film while pressing the patch firmly to the skin
  • Use 1 patch for up to 8 hours

Children 12 years and under: Ask a doctor

Do Not Use: (Do not use:)
  • More than 1 patch on your body at a time
  • On wounds, damaged, irritated or swollen skin
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
Administration

Remove patch from outer package.

Partially peel back protective film.

Place on affected area.

Remove remaining film while pressing patch to skin.

Active Ingredient

Lidocaine 4%

Other Information

Store at room temperature (20-25 C / 68-77 F)

Inactive Ingredients

Glycerin, Sodium polyacrylate, Water, Methylparaben, Propylparaben, Dihydroxyaluminum aminoacetate, Tartaric acid, PVP, Polysorbate 80, Kaolin, Titanium Dioxide, Propylene glycol, Polyacrylic acid

Questions Or Comments (Questions or Comments)

864-432-4006 [email protected]

When Using This Product: (When using this product:)
  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do not bandage tightly or apply local heat (such as heating pads) to the area
  • Do not use with other topical analgesics at the same time
  • Dispose of used patches safely, always keeping them away from children and pets
  • Used patches still contain medication that can cause serious harm if chewed or ingested
  • A temporary burning sensation may occur upon application but usually goes away in a few days
  • If a severe burning sensation occurs, stop use immediately
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Ask a healthcare professional before use

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Condition worsens
  • You experience signs of skin injury, such as redness, irritation, pain, swelling, or blistering where the product was applied
  • Symptoms persist for more than 7 days, or clear up and return within a few days
4% Lidocaine Pain Relief Gel Patch (4% lidocaine pain relief gel patch)

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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