FEI LIDOCAINE&MENTHOL PAIN RELIEF GEL-PATCH, 5 Patches

Manufacturer
Fabrication Enterprises | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2022-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:03

Label at a glance#

ProductPoint relief Lidospot
Active ingredientMENTHOL, LIDOCAINE
Label structure13 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adult and Children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply stickly side of patch to affected area. Use one patch for up to 12 hours. 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic

Menthol 1.0% w/w ...... Purpose: Topical analgesic

Purposes

OTC - PURPOSE SECTION

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other analgesics
  • Do not bandage 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.

Do not use

OTC - DO NOT USE SECTION

  • 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.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • Condition worsen
  • 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 of skin injury such as pain, swelling or blistering where the product applied.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and Children 12 years of age and over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply stickly side of patch to affected area. Use one patch for up to 12 hours.

Children under 12 years of age: Consult a physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide, Polysorbate 80, Mineral Oil, Propylene Glycol, L(+)-Tartaric Acid, Polyacrylic Acid, PolyvinylPyrrolidone K90, Hydroxyacetophenone, Water

Other information

STORAGE AND HANDLING SECTION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Package label. Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01010505

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51452-173-052024-01-30C16284748780-11030e365-2cf9-111a-e063-dadaa90a10e2FEI LIDOCAINE&MENTHOL PAIN RELIEF GEL-PATCH, 5 Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-173-01Point relief Lidospot3 g in 1 PATCHPATCH31
51452-173-05Point relief Lidospot5 in 1 POUCHPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-173POINT RELIEF LIDOSPOT (LIDOCAINE, MENTHOL) PATCH [FABRICATION ENTERPRISES]1Legacy NDC, 2 package rows20220405_db72a44e-a827-9fa5-e053-2995a90aa7de.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51452-17351452-173-01, 51452-173-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
db72a44e-a828-9fa5-e053-2995a90aa7dedb72a44e-a827-9fa5-e053-2995a90aa7de2022-04-05WarningsExact identifier
spl id: db72a44e-a828-9fa5-e053-2995a90aa7de
spl set id: db72a44e-a827-9fa5-e053-2995a90aa7de

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.