Icy Hot Max Pain Relief Patch

Manufacturer
Lead Chemical Co. Ltd.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:07:33

Label at a glance#

ProductIcy Hot
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure12 sections

Dosage and administration

adults and children 12 years of age and older: • 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 a...

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

  • on puncture wounds, cuts, irritated, damaged or swollen skin
  • more than 1 patch on your body at a time or with other topical analgesics at the same time
  • with a heating pad or apply local heat to the area of use

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes and mucous membranes
  • rare cases of serious burns have been reported with products of this type
  • a transient burning sensation may occur upon application but generally disappears in several days
  • 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 or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • severe burning sensation, redness, or irritation develops
  • 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 12 years of age and older:

  • 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 at a time and not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIDOCAINE 4% + MENTHOL 1%

ICY HOT®
MAX
Pain Relief Patch

LIDOCAINE
PATCH

  • Maximum Strength Lidocaine
    Without a Prescription*
  • Penetrates for Fast, Targeted Relief
  • Comfortable Fabric
  • Stays in Place

*Among OTC Topical Analgesics
Contains 1 Patch
3-15/16” x 5-1/2” (10 cm x 14 cm)

CHATTEM®
A SANOFI COMPANY
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2020
www.icyhot.com     Made in Japan.

image-01
image-01

Label

DailyMed Pharmacologic Classes#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62168-1720-2Icy Hot1 in 1 POUCHPATCH16
62168-1720-2Icy Hot400 in 1 CARTONPATCH4006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62168-1720ICY HOT (LIDOCAINE, MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]6Current NDC, Legacy NDC, 2 package rows20240119_1830c5ce-60e2-40e7-96cb-c5f7b9357ae5.zip

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
62168-172062168-1720-2

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
Icy HotLIDOCAINE, MENTHOLLead Chemical Co. Ltd.1830c5ce-60e2-40e7-96cb-c5f7b9357ae52024-01-02WarningsExact identifier
ndc (package): 62168-1720-2
ndc (product): 62168-1720
ndc11 (package): 62168172002
spl id: 2ce5d809-4f1b-45b9-93f5-3fcd41b9ed34
spl set id: 1830c5ce-60e2-40e7-96cb-c5f7b9357ae5

Reported adverse events (FAERS/openFDA)#

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