Lidocaine 4% Topical Patch

Lidocaine 4% Topical Patch
SPL v8
SPL
SPL Set ID c31957dd-edea-ce98-e053-2a95a90a9c2d
Route
TOPICAL
Published
Effective Date 2021-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Flax Seed Polysorbate 80 Acrylic Acid

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-24

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. 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 70512-014-30

Qty: 30 Flex Patches

(5 per resealable pouch) x 6

Manufactured for:

SOLA Pharmaceuticals

Baton Rouge, LA 70810

Section 53414-9

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

Warnings

For external use only

Directions

Adults and children 12 years of age or 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

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Active Ingredients

Lidocaine 4%


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 70512-014-30

Qty: 30 Flex Patches

(5 per resealable pouch) x 6

Manufactured for:

SOLA Pharmaceuticals

Baton Rouge, LA 70810

Section 53414-9 (53414-9)

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

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age or 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

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Active Ingredients

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)