Pain Relief Gel-Patch

Manufacturer
R & Y Group, LLC | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:32

Label at a glance#

ProductPain Relief Gel-Patch
Active ingredientLIDOCAINE, MENTHOL
Label structure13 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adult 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

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

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

Purpose

OTC - PURPOSE SECTION

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

  • Use only as directed
  • For external use only
  • Avoid contact with eyes
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

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

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

Stop use and consult a doctor if

OTC - STOP USE SECTION

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

Adult 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Package label. Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83016-172-01A83016-172-01A83016-172-01B83016-172-01B83016-172-0783016-172-07

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83016-17283016-172-01, 83016-172-07

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
0d00bbfb-a721-2bf1-e063-6394a90a0c71ebc923ff-3826-4def-e053-2995a90a1f722023-12-21WarningsExact identifier
spl id: 0d00bbfb-a721-2bf1-e063-6394a90a0c71
spl set id: ebc923ff-3826-4def-e053-2995a90a1f72

Reported adverse events (FAERS/openFDA)#

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