FDA.reportPublic FDA data

Icy Hot

Manufacturer
Nichiban Company Limited
Effective date
2009-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:06

Label at a glance#

ProductIcy Hot Medicated Roll, Medium
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

adults and children over 12 years : tear or cut roll to desired size carefully remove backing from one end of strip and place on affected area remove remaining backing and press into place wear Icy Hot Medicated Roll for up to 8 hours repeat as necessary, but no more than 3 to 4 times daily children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • do not overwrap or wrap strips over themselves
  • do not wrap around neck
  • do not apply over large areas of the body or apply in strips longer than 6 inches
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

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

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

adults and children over 12 years:

  • tear or cut roll to desired size
  • carefully remove backing from one end of strip and place on affected area
  • remove remaining backing and press into place
  • wear Icy Hot Medicated Roll for up to 8 hours
  • repeat as necessary, but no more than 3 to 4 times daily

children 12 years or younger: ask a doctor

SPL UNCLASSIFIED SECTION

Keep carton as it contains important information for usage of this product.

Distributed by Chattem, Inc.

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

© 2009 www.icyhot.com

MADE IN JAPAN
[NDC Code]

Principal Display Panel - Medium Roll, Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Reseal Pouch After Opening

ICY HOT® MEDICATED ROLL
Menthol 7.5%

CUSTOMIZED PAIN RELIEF

  • Tear or Cut to Any Length
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

EXTRA STRENGTH
MEDIUM - 2"

Pain Relieving Ointment on Breathable, Flexible Fabric

2" x 60" (5 cm x 150 cm)

Medium Roll Pouch
Medium Roll Pouch

Principal Display Panel - Large Roll, Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Reseal Pouch After Opening

ICY HOT® MEDICATED ROLL
Menthol 7.5%

CUSTOMIZED PAIN RELIEF

  • Tear or Cut to Any Length
  • Lasts up to 8 Hours
  • Comfortable, Flexible, Stays in Place

EXTRA STRENGTH
LARGE - 3"

Pain Relieving Ointment on Breathable, Flexible Fabric

3" x 43" (7.5 cm x 110 cm)

Large Roll Pouch
Large Roll Pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010823menthol 7.5 % Medicated PatchPSN1
1010823menthol 0.075 MG/MG Medicated PatchSCD1
1010823menthol 7.5 % Medicated PatchSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44014-085-012019-10-21C16284748780-1956f9ecf-c5e8-621f-e053-dbdaa90a74adDrug Facts
44014-085-032019-10-21C16284748780-1956f9ecf-c5e8-621f-e053-dbdaa90a74adDrug Facts
44014-086-022019-10-21C16284748780-1956f9ecf-c5e8-621f-e053-dbdaa90a74adDrug Facts
44014-086-072019-10-21C16284748780-1956f9ecf-c5e8-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44014-085-01Icy HotMedicated Roll, Medium1 in 1 POUCHPATCH11
44014-085-03Icy HotMedicated Roll, Medium170 in 1 BOXPATCH1701
44014-086-02Icy HotMedicated Roll, Large150 in 1 BOXPATCH1501
44014-086-07Icy HotMedicated Roll, Large1 in 1 POUCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44014-085ICY HOT MEDICATED ROLL, MEDIUM (MENTHOL) PATCH ICY HOT MEDICATED ROLL, LARGE (MENTHOL) PATCH [NICHIBAN COMPANY LIMITED]1Legacy NDC, 2 package rows20091228_3656d7ee-bd4c-422c-8e4b-f24517dddc57.zip
44014-086ICY HOT MEDICATED ROLL, MEDIUM (MENTHOL) PATCH ICY HOT MEDICATED ROLL, LARGE (MENTHOL) PATCH [NICHIBAN COMPANY LIMITED]1Legacy NDC, 2 package rows20091228_3656d7ee-bd4c-422c-8e4b-f24517dddc57.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44014-08544014-085-01, 44014-085-03
44014-08644014-086-07, 44014-086-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
MENTHOLL7T10EIP3AACTIB

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
3656d7ee-bd4c-422c-8e4b-f24517dddc573656d7ee-bd4c-422c-8e4b-f24517dddc572009-12-23WarningsExact identifier
spl id: 3656d7ee-bd4c-422c-8e4b-f24517dddc57
spl set id: 3656d7ee-bd4c-422c-8e4b-f24517dddc57

Reported adverse events (FAERS/openFDA)#

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