Storage and handling
Other information •Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight •Protect product from excessive moisture
Other information •Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight •Protect product from excessive moisture
Active ingredients
Lidocaine 4%
Purpose
Topical analgesic
Uses temporarily releives minor pain
Warnings for external use only.
Do not use
•more than one patch on your body at a time or on cut •on wounds or damaged skin •with a heating pad
When using this product
•avoid contact with eyes, mucous membranes or rashes •use only as directed •do not bandage tightly
•do not use at the same time as other topical analgesics •dispose of used patch in a manner that always keeps products away from children and pets
Stop use and ask a doctor if
•you experience signs of skin injury, such as pain, swelling or blistering where product was applied •symptoms persist for more than 7
days or clear up and occur again within a few days •condition worsens •redness is present •irritation develops
Keep out of reach of children. On case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Pregnancy.breast-feeding warning. If pregant or breast-feeding, ask a health professional before use.
Directions Adults and children 12 years of age and over:
•Clean and dry affected area •Remove film from patch and apply to the skin (see package for instructions)
•Apply to affected area not more than 3 to 4 times daily •Remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a physician
Other information
•Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight •Protect product from excessive moisture
Inactive ingredients DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL,
PVP, POLYACRYLIC ACID, POLYSORBATE 80, SODIUM POLYACRYLATE, TITANIUM DIOXIDE, TARTARIC ACID, WATER
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69159-100-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-32b7-111a-e063-dadaa90a10e2 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69159-100-01 | Assured Pain Relief | 15 g in 1 PATCH | GEL | 15 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69159-100 | 69159-100-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIDOCAINE | 98PI200987 | ACTIB |
| DIHYDROXYALUMINUM AMINOACETATE | DO250MG0W6 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| POLYACRYLIC ACID (8000 MW) | 73861X4K5F | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SODIUM POLYACRYLATE (8000 MW) | 285CYO341L | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 8c11b9d5-2ef4-411c-84c3-7c9ccf06ae11 | bdbd4106-e4fe-4daf-a757-3aee3a87bb09 | 2017-09-08 | Warnings | 8c11b9d5-2ef4-411c-84c3-7c9ccf06ae11 bdbd4106-e4fe-4daf-a757-3aee3a87bb09 |
Adverse event summaries are temporarily unavailable. Other product information remains available.