TopCare Pain Relief Patch

Manufacturer
Topco Associates LLC | Foshan Aqua Gel Biotech Co., Ltd
Effective date
2025-12-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:56

Label at a glance#

ProductTopCare Pain Relief Patch
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure12 sections

Dosage and administration

adults and children 12 years of age and over: clean and dry affected area carefully remove backing from patch starting at a corner. Appli sticky side of patch to affected area. Use one patch for up to 12 hours Dispatch patch after a single use. children under 12 years of age: consult a physician

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purposes

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than 1 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

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 topical 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • 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 was applied

If pregnant or breast-feeding,

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 800-222-1222 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove backing from patch starting at a corner.
  • Appli sticky side of patch to affected area.
  • Use one patch for up to 12 hours
  • Dispatch patch after a single use.
  • children under 12 years of age: consult a physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN4
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD4
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY4

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
76162-007-05TopCare Pain Relief Patch1 g in 1 POUCHPATCH14
76162-007-05TopCare Pain Relief Patch5 in 1 CARTONPATCH54

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-00776162-007-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
TopCare Pain Relief PatchLIDOCAINE, MENTHOLTopco Associates LLCd4c89c4f-d69a-7786-e053-2995a90a71e72025-12-28WarningsExact identifier
ndc (package): 76162-007-05
ndc (product): 76162-007
ndc11 (package): 76162000705
spl id: 470668b9-14d4-6b68-e063-6294a90a398f
spl set id: d4c89c4f-d69a-7786-e053-2995a90a71e7

Reported adverse events (FAERS/openFDA)#

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