FDA.reportPublic FDA data

HOT COLD LIDOCAINE WITH MENTHOL PATCH

Manufacturer
Foshan Aqua Gel Biotech Co., Ltd.,
Effective date
2017-10-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:52:39

Label at a glance#

ProductHOT COLD LIDOCAINE WITH MENTHOL
Active ingredientLIDOCAINE, MENTHOL
Label structure13 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adults and children over 12 years: clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch for ...

Label contents#

Full prescribing information#

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OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic/ Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor 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 or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When Using This Product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children or 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic acid, Propylene glycol, Propylparaben, PVP, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Tween 80, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hot and cold china patch bulkhot and cold china patch bulk

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822686150GTIN-13: 0011822686150
EAN-13: 0011822686150
GTIN-12: 011822686150
UPC-A: 011822686150
GTIN storage (14 digits): 00011822686150		hot and cold china patch bulk.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69159-004-012024-01-30C16284748780-11030e365-502b-111a-e063-dadaa90a10e2HOT COLD LIDOCAINE WITH MENTHOL PATCH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69159-004-01HOT COLD LIDOCAINE WITH MENTHOL300 in 1 CASEPATCH3004
69159-004-01HOT COLD LIDOCAINE WITH MENTHOL1 in 1 PATCHPATCH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69159-004HOT COLD LIDOCAINE WITH MENTHOL (LIDOCAINE, MENTHOL) PATCH [FOSHAN AQUA GEL BIOTECH CO., LTD.,]4Legacy NDC, 2 package rows20171009_58ebb3fe-08ff-e8b0-e053-2991aa0a56de.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69159-00469159-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
POLYACRYLIC ACID (300000 MW)A8371R0U5JIACT
POVIDONEFZ989GH94EIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 806OZP39ZG8HIACT

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
5b1ffe32-1642-35e3-e053-2991aa0a7d8b58ebb3fe-08ff-e8b0-e053-2991aa0a56de2017-10-09WarningsExact identifier
spl id: 5b1ffe32-1642-35e3-e053-2991aa0a7d8b
spl set id: 58ebb3fe-08ff-e8b0-e053-2991aa0a56de

Reported adverse events (FAERS/openFDA)#

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