OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)
Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)
Active Ingredient
Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)
Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)
Purpose
(Lidocaine) Topical Anesthetic
(Menthol) Topical Analgesic
Warnings
For external use only
Use
Temporary relief of pain
Do not use
• On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged skin • on puncture wounds • for more than one week without consulting a doctor.
When using this product
• Use only as directed. Read and follow all directions and warnings on this label
• Do not allow contact with eyes and mucous membranes
• Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use
• Do not use at the same time as other topical analgesics
Stop use if
• Condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and occur within a few days
Ask a doctor if
• Condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and occur within a few days
Flammable
• Keep away from fire or flame
If pregnant or breast-feeding
Keep out of reach of children
If swallowed, get medical help or contact the Poison Control Center right away
Directions
Adults and children 12 years of age and over:
Children under 12 years old: Consult a doctor
Inactive Ingredients
Aloe Vera Extract, Carbomer, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water
Child-resistant packaging. Close the cap tightly after use.
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 5060643133300 | GTIN-13: 5060643133300 EAN-13: 5060643133300 GTIN storage (14 digits): 05060643133300 | Principal Display Panel-Menthol Lidocaine.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84008-002-01 | Pain Relief Gel-Roll On | 73 mL in 1 BOTTLE | GEL | 73 | 1 | |
| 84008-002-02 | Pain Relief Gel-Roll On | 1 in 1 BOX | GEL | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84008-002 | 84008-002-01, 84008-002-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| POLYACRYLIC ACID (250000 MW) | 9G2MAD7J6W | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| LAVENDER OIL | ZBP1YXW0H8 | IACT |
| .ALPHA.-TOCOPHEROL, D- | N9PR3490H9 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
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 |
|---|---|---|---|---|---|---|
| Pain Relief Gel-Roll On | LIDOCAINE AND MENTHOL | Bullet point LLC | 42c70681-494b-47c9-e063-6394a90a80be | 2025-11-04 | Warnings | 84008-002-02 84008-002-01 84008-002 84008000201 84008000202 42c70b4f-638a-658c-e063-6294a90a0ea8 42c70681-494b-47c9-e063-6394a90a80be |
Adverse event summaries are temporarily unavailable. Other product information remains available.