Lidocaine 4%

Lidocaine 4%
SPL v3
SPL
SPL Set ID 14edf7dc-c5dc-4b74-b583-0f87529f4536
Route
TOPICAL
Published
Effective Date 2024-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Butylated Hydroxytoluene Carboxymethylcellulose Sodium Glycerin Sorbitol Edetate Disodium Isopropyl Myristate Kaolin Silodrate Anhydrous 2-ethylhexyl Acrylate Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Water Sodium Polyacrylate (2500000 Mw) Sorbitan Sesquioleate Tartaric Acid Titanium Dioxide Urea

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-06-27
Description

Lidocaine 4%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the 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

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

Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Questions or comments? 877-367-3250

Section 51945-4

Packaged For:

Forreal Pharmaceuticals LLC

Royal Oak, MI 48067

Questions or Comments please call 877-367-3250

NDC 81877-514-15

Qty:15 Patches

(5 per Resealable Pouch) x 3

Lidocaine 4%

Topical Pain Patch

for temporary pain relief

Section 53414-9

If pregnant or breast-feeding

Ask a health professional before use.

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4%

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

Structured Label Content

Indications and Usage (34067-9)

For the 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)

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)

Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Questions or comments? 877-367-3250

Section 51945-4 (51945-4)

Packaged For:

Forreal Pharmaceuticals LLC

Royal Oak, MI 48067

Questions or Comments please call 877-367-3250

NDC 81877-514-15

Qty:15 Patches

(5 per Resealable Pouch) x 3

Lidocaine 4%

Topical Pain Patch

for temporary pain relief

Section 53414-9 (53414-9)

If pregnant or breast-feeding

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%

Other Information: (Other information:)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:08.687262 · Updated: 2026-03-14T23:03:02.507799