Lidocaine Pain Relieving Patch - Lidocaine 4%

Lidocaine Pain Relieving Patch - Lidocaine 4%
SPL v2
SPL
SPL Set ID 3117273d-e006-2726-e063-6294a90a9c33
Route
TOPICAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Tartaric Acid Polysorbate 80 Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous Methylparaben Edetate Sodium Propylparaben Water Glycerin Carboxymethylcellulose Sodium, Unspecified Form Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-18

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses

For the temporary relief of pain

Section 50565-1

Keep Out of Reach of Children and Pets. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings:

For external use only.

Do Not Use

  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Directions:

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a physician.

  • Clean and dry affected area
  • Remove the film from the patch and apply to the affected area
  • Use 1 patch at a time and not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8 hours application

Active Ingredient

Lidocaine 4%

Other Information
  • Do not use if the pouch is opened or damaged
  • Tighlty reseal the pouch containing unused patches
  • Store at room temperature
  • Do not freeze
  • This package is child-resistant
Inactive Ingredients

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Methyl parahydroxybenzoate (Methylparaben), Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate (Propylparaben), Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.

Questions Or Comments?

Call toll-free 1-800-655-0252 or email: [email protected]

Principal Display Panel

Lidocaine Pain Relieving Patch Pouch 4%

NDC 68001-625-89

Rev 05/25

Lidocaine Pain Relieving Patch 5 Patch Carton 4%

NDC 68001-625-93

Rev 08/25

Lidocaine Pain Relieving Patch 30 Patch Carton 4%

NDC 68001-625-95

Rev 08/25

When Using This Product

  • Use only as directed
  • Do not bandage tightly
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not apply to open wounds or damaged skin
Stop Use and Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days or clears up and occurs again within a few days
  • Severe burning sensation, redness or irritation develops
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Structured Label Content

Uses

For the temporary relief of pain

Section 50565-1 (50565-1)

Keep Out of Reach of Children and Pets. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical anesthetic

Warnings:

For external use only.

Do Not Use (Do not Use)

  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Directions:

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a physician.

  • Clean and dry affected area
  • Remove the film from the patch and apply to the affected area
  • Use 1 patch at a time and not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8 hours application

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)
  • Do not use if the pouch is opened or damaged
  • Tighlty reseal the pouch containing unused patches
  • Store at room temperature
  • Do not freeze
  • This package is child-resistant
Inactive Ingredients (Inactive ingredients)

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Methyl parahydroxybenzoate (Methylparaben), Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate (Propylparaben), Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-655-0252 or email: [email protected]

Principal Display Panel

Lidocaine Pain Relieving Patch Pouch 4%

NDC 68001-625-89

Rev 05/25

Lidocaine Pain Relieving Patch 5 Patch Carton 4%

NDC 68001-625-93

Rev 08/25

Lidocaine Pain Relieving Patch 30 Patch Carton 4%

NDC 68001-625-95

Rev 08/25

When Using This Product

  • Use only as directed
  • Do not bandage tightly
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not apply to open wounds or damaged skin
Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor if)

  • Condition worsens
  • Symptoms persist for more than 7 days or clears up and occurs again within a few days
  • Severe burning sensation, redness or irritation develops
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Advanced Ingredient Data


Raw Label Data

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