Indications and uses
For the temporary relief of pain.
Parche Leon Gel Patch (SHANGHAI G)
- Manufacturer
- Pharmadel LLC
- Effective date
- 2025-01-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:42:50
Label at a glance#
ProductParche de Leon
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure7 sections
Dosage and administration
adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor - clean dry affected area - remove patch from film - apply sticky side of patch to affected area - use one patch at a time - leave patch on affected area for up to 8-hours at a time
Label contents#
Full prescribing information#
Drug Facts
Active Ingredients & Purpose
OTC - PURPOSE SECTION
| Active ingredients (in each patch) | Purpose |
| Lidocaine 4% ................. | External analgesic |
| Menthol 1% .................... | External analgesic |
Uses
For the temporary relief of pain.
Warnings
FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
Do not use
- in large quantities, particularly over raw surfaces or blistered areas
- on sensitive skin
- if allergic to any ingredients in this product
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
If pregnant of breast-feeding
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a doctor
- clean dry affected area
- remove patch from film
- apply sticky side of patch to affected area
- use one patch at a time
- leave patch on affected area for up to 8-hours at a time
Other Information
- store at room temperature 59-86 F (15-30 C)
- do not store in direct sunlight or expose to excessive heat
TAMPER EVIDENT: Do not use if packet containing the patch is torn or broken.
Inactive Ingredients
dihydroxyaluminum aminoacetate anhydrous, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid,
polysorbate 80, propylene glycol, povidone k90, sodium polyacrylate, tartaric acid, titanium dioxide, water
Principal Display Panel
5 Patches (5.5 in x 3.94 in (13.97 cm x 10 cm) each)
- Maximum Strength
- Fast Acting pain relief
Products#
Every source-derived product name is available through these pages.
- Parche de Leon
- Lidocaine, Menthol
- EDETATE DISODIUM
- PROPYLENE GLYCOL
- WATER
- DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS
- POVIDONE K90
- KAOLIN
- POLYSORBATE 80
- POLYACRYLIC ACID (800000 MW)
- TITANIUM DIOXIDE
- GLYCERIN
- SODIUM POLYACRYLATE (8000 MW)
- TARTARIC ACID
- HYDROXYACETOPHENONE
- MINERAL OIL
- LIDOCAINE
- MENTHOL, UNSPECIFIED FORM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-040 | 55758-040-01, 55758-040-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 2b9cfd90-ff0e-839b-e063-6294a90aa29d | da833ccc-9a94-6bfc-e053-2a95a90a4da3 | 2025-01-13 | Warnings | 2b9cfd90-ff0e-839b-e063-6294a90aa29d da833ccc-9a94-6bfc-e053-2a95a90a4da3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.