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

Active Ingredient

Lidocaine 4%

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

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

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Lidocaine 4%

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

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

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