FDA.reportPublic FDA data

ICY HOT ® Kids Pain Relief Patch

Manufacturer
Lead Chemical Co., Ltd.
Effective date
2025-04-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:39:33

Label at a glance#

ProductIcy Hot Kids Pain Relief
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure7 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

Dosage and administration

children 5 years of age and older: • patch may be cut into smaller sizes with scissors prior to removal of the backing • 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 backi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or on irritated or damaged skin
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not expose the area to local heat or to direct sunlight
  • 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
  • avoid applying into skin folds

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
  • redness is present or excessive skin irritation occurs
  • your child experiences severe burning 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.

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

children 5 years of age and older:

  • patch may be cut into smaller sizes with scissors prior to removal of the backing
  • 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
  • apply to affected area not more than 3 to 4 times daily
  • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.

children under 5 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water

Principal Display Panel – Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICY HOT®
KIDS
PAIN RELIEF
PATCH
FAST ACTING
EASY TO APPLY AND REMOVE
WEAR UP TO 8 HOURS
WITH NATURALLY-SOURCED
MENTHOL 5%
DEVELOPED WITH PEDIATRICIANS
AGES 5+
CONTAINS 5 PATCHES IN ONE RESEALABLE POUCH
3-1/8" x 4-5/8" (8 cm x 12 cm) EACH


PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION
Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
©2022     www.icyhot.com

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Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62168-0228ICY HOT KIDS PAIN RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO., LTD.]3Unmatched20250425_b11d93b9-39e1-46b5-ae7f-cbb5885e87e2.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
62168-022862168-0228-1

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
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
NONOXYNOL-30JJX07DG188IACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
TALC7SEV7J4R1UIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

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
8a63f38f-085a-4a7b-9dd2-a9c0c2ed827eb11d93b9-39e1-46b5-ae7f-cbb5885e87e22025-04-21WarningsExact identifier
spl id: 8a63f38f-085a-4a7b-9dd2-a9c0c2ed827e
spl set id: b11d93b9-39e1-46b5-ae7f-cbb5885e87e2

Reported adverse events (FAERS/openFDA)#

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