Indications and uses
Temporarily relieves minor pain.
Loxyine Maximum Strength Lidocaine Pain Relieving Patch
- Manufacturer
- Sj Incorporation Ltd
- Effective date
- 2023-11-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:37
Label at a glance#
ProductLoxyine
Active ingredientLIDOCAINE
Label structure9 sections
Dosage and administration
Adults and children 12 years of age and over: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one path for up to 12 hours. Discard patch after single use. Children under 12 years of age: Consult a physician.
Storage and handling
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Lidocaine 4.0%
Purpose
Topical anesthetic
Uses
Temporarily relieves minor pain.
Warnings
For external use only
Do not use
- more than one patch on your body at a time
- On cut, irritated or swollen skin
- On puncture wounds
- For more than one week without consulting a doctor
- If you are allergic to any active or inactive ingredients
- If pouch is damaged or opened.
When using this product
- use only as directed
- Read and follow all directions and warning on this pack
- Do not allow contact with the eyes
- Do not use at the same time as other topical analgesics
- Do not bandage only tightly or apply local heat (such as heating pads) to the area of use
- Do not microwave
- 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
- Condition worsens
- Redness is present
- Irritation develops
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- You experience signs or skin injury, such as pain, swelling or blistering where the product was applied.
If pregnant or breast-feeding,
ask a healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.
Directions
Adults and children 12 years of age and over: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one path for up to 12 hours. Discard patch after single use.
Children under 12 years of age: Consult a physician.
Other information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Inactive ingredients
aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water.
Questions or comments?
Toll free 1-800-587-4041
Principal Display Panel
DailyMed RxNorm Mappings#
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83658-011-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-63d5-d83d-e063-dadaa90ab31f | Loxyine Maximum Strength Lidocaine Pain Relieving Patch |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83658-011-01 | Loxyine | 1 mg in 1 POUCH | PATCH | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Loxyine
- Lidocaine
- ALUMINIUM TRIGLYCINATE
- GLYCERIN
- KAOLIN
- METHYLPARABEN
- POLYACRYLIC ACID (8000 MW)
- POLYSORBATE 80
- PROPYLENE GLYCOL
- PROPYLPARABEN
- SODIUM POLYACRYLATE (8000 MW)
- TARTARIC ACID
- TITANIUM DIOXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83658-011 | 83658-011-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALUMINIUM TRIGLYCINATE | 5TLG1CL557 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYACRYLIC ACID (8000 MW) | 73861X4K5F | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM POLYACRYLATE (8000 MW) | 285CYO341L | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 0a9fe520-83b2-3452-e063-6294a90a15ab | cfd24059-707d-4474-8041-8fdc30b88631 | 2023-11-20 | Warnings | 0a9fe520-83b2-3452-e063-6294a90a15ab cfd24059-707d-4474-8041-8fdc30b88631 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.