Lidocaine 4% Patch

Lidocaine 4% Patch
SPL v6
SPL
SPL Set ID 078bc9a3-41b7-26a4-e063-6394a90a200d
Route
TOPICAL
Published
Effective Date 2023-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Titanium Dioxide Glycerin Disodium Ethylenediaminediacetate Sodium Polyacrylate (2500000 Mw) Propylparaben Water Kaolin Polysorbate 80 Povidone K90 Dihydroxyaluminum Aminoacetate Propylene Glycol Polyacrylic Acid (250000 Mw) Tartaric Acid

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-12

Description

Lidocaine

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine

Uses

For the temporary relief of pain

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Section 50570-1

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Section 51945-4

Questions or comments? 866-747-7365

Lidocaine 4% Patch

NDC 70512-812-30

Qty: 30 patches

Manufactured for:

SOLA Pharmaceuticals

Baton Rouge, LA 70810

Made in China

Section 53414-9

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

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Other Ingredients

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Active Ingredients

Lidocaine


Structured Label Content

Uses

For the temporary relief of pain

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Section 50570-1 (50570-1)

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Section 51945-4 (51945-4)

Questions or comments? 866-747-7365

Lidocaine 4% Patch

NDC 70512-812-30

Qty: 30 patches

Manufactured for:

SOLA Pharmaceuticals

Baton Rouge, LA 70810

Made in China

Section 53414-9 (53414-9)

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

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Other Ingredients

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Active Ingredients

Lidocaine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)