Indications and uses
Uses For the temporary relief of pain
Uses For the temporary relief of pain
Active ingredient:
Lidocaine 4%
Purpose:
Pain Relieving Patch
Uses
For the temporary relief of pain
Warnings
For external use only.
Do not use
more than 1 patch on your body at a time or with other topical anesthetics at the same time
on wounds, damaged skin, rashes, or swollen skin
with a heating pad or apply local heat to the area of use
in large quantities, particularly over raw surfaces or blistered areas
When using this product
use only as directed
do not bandage tightly
avoid contact with the eyes or on mucous membranes
dispose of used patch in manner that always keeps product away from children and pets.
Used patches still contain the drug product that can produce serious adverse effects if a
child or pet chews or ingests this patch.
Stop use and ask a doctor if
the condition for which this preparation is used persists or if a rash, redness or
irritation develops
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again
within few days
you experience pain, swelling or blistering of the skin
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children and pets. If swallowed, get medical help or contact a
Poison Control Center right away.
Uses
For the temporary relief of pain
Keep out of reach of children and pets. If swallowed, get medical help or contact a
Poison Control Center right away.
Directions
adults and children 12 years of age and older: Clean and dry affected area, cut open pouch
and remove patch from protective film by first peeling back center film. Apply exposed patch
to affected area. Carefully remove remaining film while pressing the patch to skin and leave in
place for up to 8 hours. (see images on carton)
use 1 patch at a time and not more than 3 to 4 times daily
children under 12 years of age: consult a physician
wash hands after use with cool water
Other information
store at 20-25°C (68-77°F)
store in a cool dry place away from direct sunlight
Inactive ingredients:
Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene,
Styrene/Isoprene/Styrene Block Copolymer
Questions or comments? 1-866-682-4639
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0731124444967 | GTIN-13: 0731124444967 EAN-13: 0731124444967 GTIN-12: 731124444967 UPC-A: 731124444967 GTIN storage (14 digits): 00731124444967 | 59316-899 carton label.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 |
| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59316-899 | 59316-899-04, 59316-899-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCEROL ESTER OF HYDROGENATED ROSIN | XH62RP786N | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| POLYISOBUTYLENE (55000 MW) | TQ77WR8A02 | IACT |
| STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER | K7S96QM8DV | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2026-05-15 | full-release | 2026-06-01 01:57:39 |
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 |
|---|---|---|---|---|---|---|
| Biofreeze Ultraflex | LIDOCAINE | Reckitt Benckiser LLC | 2655974b-a67d-9f07-e063-6294a90a54e8 | 2026-06-02 | Warnings | 59316-899-07 59316-899-04 59316-899 59316089904 59316089907 5348f92e-a770-de13-e063-6294a90adbcc 2655974b-a67d-9f07-e063-6294a90a54e8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.