Indications and uses
Temporarily relieves pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations
Lidocaine Patch
- Manufacturer
- Alexso, Inc
- Effective date
- 2024-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:41:06
Label at a glance#
ProductLidocaine
Active ingredientLIDOCAINE
Label structure9 sections
Dosage and administration
Adults and children 12 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. Clean and dry the affected area. Open pouch and remove one patch. Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. Wash hands with soap and water after handlin...
Storage and handling
Store at room temperature 15°-30°C (59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
LIDOCAINE – Lidocaine 4% Patch
Alexso, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Lidocaine 4% Patch
Drug Facts
Active ingredient
Lidocaine 4%
Purpose
External analgesic
Uses
Temporarily relieves pain and itching associated with:
• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations
Warnings
For external use only.
Read all warnings and directions before use.
Do not use
• More than one patch at a time
• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product
Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.
When using this product
• Use only as directed.
• Avoid contact with eyes, mucous membranes, or rashes
• Do not tightly wrap or bandage the treated area
Stop use and ask a physician:
• If pregnant or breast feeding
• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 12 years of age and older:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 12 years: Ask a physician
Other information
Store at room temperature 15°-30°C (59°-86°F)
Avoid storing product in direct sunlight and protect product from excessive moisture.
Inactive ingredients
Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil
PRINCIPAL DISPLAY PANEL
Lidocaine 4% Patch
NDC 50488-2004-1
10 Patches per Box
Alexso, Inc
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50488-2004-1 | Lidocaine | 10 in 1 CARTON | PATCH | 10 | 4 | |
| 50488-2004-1 | Lidocaine | 100 g in 1 PATCH | PATCH | 100 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50488-2004 | LIDOCAINE PATCH [ALEXSO, INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241208_c4e41113-7bf1-4fe9-b460-73e7b839c7a2.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-2004-1 | EA - Each | 50488-2004 | c2dbb3e1-6499-46ad-b491-fe8ee0523062 | 1 | 2020-02-13 |
Products#
Every source-derived product name is available through these pages.
- Lidocaine
- WATER
- GLYCERIN
- PROPYLENE GLYCOL
- POLYSORBATE 80
- TARTARIC ACID
- DIHYDROXYALUMINUM AMINOACETATE
- METHYLPARABEN
- PEPPERMINT OIL
- SODIUM POLYACRYLATE (8000 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50488-2004 | 50488-2004-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIDOCAINE | 98PI200987 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| DIHYDROXYALUMINUM AMINOACETATE | DO250MG0W6 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| SODIUM POLYACRYLATE (8000 MW) | 285CYO341L | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lidocaine | LIDOCAINE | Alexso, Inc | c4e41113-7bf1-4fe9-b460-73e7b839c7a2 | 2024-12-09 | Warnings | 50488-2004-1 50488-2004 50488200401 c0947407-7431-413a-9278-2df9e92c0e91 c4e41113-7bf1-4fe9-b460-73e7b839c7a2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.