Pain Relief Gel-Patch

Manufacturer
R & Y Group, LLC | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:31:48

Label at a glance#

ProductPain Relief Gel-Patch
Active ingredientMENTHOL, LIDOCAINE
Label structure13 sections

Dosage and administration

Adults and Children 12 years of age and over . Clean and dry affected area Remove film from patch and apply to the skin Apply to affected area not more than 3 to 4 times daily Remove patch from the skin after 8-hour application at most Children under 12 years of age : Consult a physician

Storage and handling

Store at 68° - 77° F (20° - 25° C) Store in a cool dry place away from direct sunlight

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w ...... Purpose: Topical Anesthetic

Menthol 1% w/w ...... Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic (Lidocaine)

Topical Analgesic (Menthol)

Use

INDICATIONS & USAGE SECTION

for temporary relief of pain

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

  • More than 1 patch at a time
  • If you are allergic to any ingredients of this product
  • On wounds or damaged skin
  • In large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • Localized skin reactions occur, such as a rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms clear up and occur again within a few days
  • Symptoms persist for more than 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a physician before use.

Keep out of reach of children.

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

Adults and Children 12 years of age and over.

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply to affected area not more than 3 to 4 times daily
  • Remove patch from the skin after 8-hour application at most

Children under 12 years of age: Consult a physician

Other Information

STORAGE AND HANDLING SECTION

  • Store at 68° - 77° F (20° - 25° C)
  • Store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Package label. Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01010707

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83016-171-01Pain Relief Gel-Patch12 g in 1 PACKETPATCH122
83016-171-07Pain Relief Gel-Patch7 in 1 POUCHPATCH72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83016-171PAIN RELIEF GEL-PATCH (LIDOCAINE, MENTHOL) PATCH [R & Y GROUP, LLC]2Current NDC, 2 package rows20241031_fe0478d8-2f06-cd56-e053-6294a90a58e5.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
83016-17183016-171-01, 83016-171-07

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
Pain Relief Gel-PatchLIDOCAINE, MENTHOLR & Y Group, LLCfe0478d8-2f06-cd56-e053-6294a90a58e52024-10-30WarningsExact identifier
ndc (package): 83016-171-01
ndc (package): 83016-171-07
ndc (product): 83016-171
ndc11 (package): 83016017107
ndc11 (package): 83016017101
spl id: 25ac4fb1-be51-69e9-e063-6394a90a7a64
spl set id: fe0478d8-2f06-cd56-e053-6294a90a58e5

Reported adverse events (FAERS/openFDA)#

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