Lidaflex

Lidaflex
SPL v10
SPL
SPL Set ID b9e49529-13b4-1b0b-e053-2995a90adc7a
Route
TOPICAL
Published
Effective Date 2021-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-27
Description

Active ingredients: Lidocaine 4%

Medication Information

Warnings and Precautions

Warnings:

For external use only

Indications and Usage

Uses:

For temporary relief of pain

Dosage and Administration

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

Description

Active ingredients: Lidocaine 4%

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 pathch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Section 51727-6

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Section 51945-4

​Manufactured for:

SOLA Pharmaceuticals

655 Highlandia Dr. Ste B

Baton Rouge, LA 70810

For questions for comments call 866-747-7365

LidaFlex Patch

Topical Pain Patch

For temporay pain relief

NDC 70512-012-30

Qty: 30 Flex Patches

(5 per Resealable Pouch) x 6

Section 53414-9

If Pregnant or breast-feeding

Ask a health professional before use.

Section 55105-1

Purpose:

Topical Anesthetic

Section 55106-9

Active ingredients:

Lidocaine 4%

Section 60561-8

Other information:

  • Avoid storing product in direct sunlight
  • Protect product from exceessive moisture

Structured Label Content

Indications and Usage (34067-9)

Uses:

For temporary relief of pain

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings:

For external use only

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 pathch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Section 51727-6 (51727-6)

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Section 51945-4 (51945-4)

​Manufactured for:

SOLA Pharmaceuticals

655 Highlandia Dr. Ste B

Baton Rouge, LA 70810

For questions for comments call 866-747-7365

LidaFlex Patch

Topical Pain Patch

For temporay pain relief

NDC 70512-012-30

Qty: 30 Flex Patches

(5 per Resealable Pouch) x 6

Section 53414-9 (53414-9)

If Pregnant or breast-feeding

Ask a health professional before use.

Section 55105-1 (55105-1)

Purpose:

Topical Anesthetic

Section 55106-9 (55106-9)

Active ingredients:

Lidocaine 4%

Section 60561-8 (60561-8)

Other information:

  • Avoid storing product in direct sunlight
  • Protect product from exceessive moisture

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.596836 · Updated: 2026-03-14T23:11:05.615438