Indications and uses
for the temporary relief of pain
for the temporary relief of pain
Adults and children 12 years of age and older: Wash and dry the affected area. Peel off the backing film from one side of the patch carefully. Apply the exposed portion of the patch to the affected area. Gently press the patch with your hand to fit the affected area completely. Do not exercise vigorously during use to prevent the patch from falling off. Ues only 1 patch for a maximum of 8 hours. children under 12 ...
Active Ingredient
Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purpose
Topical Anesthetic
Uses
for the temporary relief of pain
Warnings
For external use only
Do not use
When using this product
Stop use and ask a doctor if
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 (1-800-222-1222).
Directions
Adults and children over 12 years:
children under 12 years of age: Ask a doctor before use
Other Information
store at room temperature 15°-30°C (59°-86°F).
Inactive ingredients
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water
Questions or Comments?
E-mail: info@carelivingusa.com
Child-Resistant Packaging
Manufactured for
CARE LIVING DIAGNOSTICS INC.
Made in China
Lidocaine 4%
Topical anesthetic
for the temporary relief of pain
For external use only
ask a health professional before use
lf swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222)
Adults and children 12 years of age and older:
children under 12 years of age:Ask a doctor before use.
store at room temperature 15°-30°C (59°-86°F).
aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water
E-mail:info@carelivingusa.com
0.246 g in 1 PATCH,5 PATCH in 1 CARTON
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83568-4643-5 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-1acf-a2ce-e063-dadaa90aadf7 | 019efef6-b8c0-59ec-e063-6294a90a3468 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83568-4643-1 | Pro Comfort 8 Hours Patch | 4 g in 1 PATCH | PATCH | 4 | 2 | |
| 83568-4643-5 | Pro Comfort 8 Hours Patch | 5 in 1 BOX | PATCH | 5 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83568-4643 | PRO COMFORT 8 HOURS PATCH (LIDOCAINE PATCH 4%) PATCH [CARE LIVING DIAGNOSTICS INC] | 2 | 2 package rows | 20230802_019efef6-b8c0-59ec-e063-6294a90a3468.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83568-4643 | 83568-4643-1, 83568-4643-5 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS | 1K713C615K | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYACRYLIC ACID (8000 MW) | 73861X4K5F | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| SODIUM POLYACRYLATE (8000 MW) | 285CYO341L | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| UREA | 8W8T17847W | IACT |
| ALCOHOL | 3K9958V90M | 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 |
|---|---|---|---|---|---|---|
| 019efef6-b8c1-59ec-e063-6294a90a3468 | 019efef6-b8c0-59ec-e063-6294a90a3468 | 2023-07-29 | Warnings | 019efef6-b8c1-59ec-e063-6294a90a3468 019efef6-b8c0-59ec-e063-6294a90a3468 |
Adverse event summaries are temporarily unavailable. Other product information remains available.