FDA.reportPublic FDA data

Pain Relief Sleeve

Manufacturer
Great Lakes Wholesale, Marketing, and Sales, Inc | Illinois Industrial Tool, Inc | Planet (Suzhou) Medical Products Co., Ltd
Effective date
2016-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:08

Label at a glance#

ProductPain Relief Sleeve Large
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 16.0%

OTC - PURPOSE SECTION

Topical Analgesic Patch

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS SECTION

For external use only

When using this product:

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad

OTC - STOP USE SECTION

Stop using and ask a doctor

if redness is present or irritation develops. Condition worsens, or if symptioms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

INSTRUCTIONS FOR USE SECTION

  • Adults and children over 12 years: pull sleeve onto knee or large ankles or elbows until the colored section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight.
  • Children 12 years or younger: consult a doctor

INACTIVE INGREDIENT SECTION

diethylene glycol monoethyl ether acetate, cetanol, glycerol, glycerol monostearate, methylparaben, 2(2-aminoethoxy) ethanol, sorbitan sesquiolate, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf extract, methyl orange-xylene cyanol solution, ethylenediaminetetracetic acid tetrasodium salt hydrate.

DESCRIPTION SECTION

NDC 64092-506-1, ITEM 863906

GLS

Personal Care Solutions

Extra Strength

Menthol 16%

Pain Relief Sleeve

KNEE & Small-Medium ankles & elbows

Medicated Sleeve

Pain relieving Lotion on a Breathable Sleeve

Medium

Ideal for KNEE

EXPANDS TO FIT 5" TO 12" (12.5cm to 30.5cm)

IN CIRCUMFERENCE

Contains 1 Sleeve Patch

KNEE

  • ELBOT
  • ANKLE
  • WRIST

NDC 64092-520-1, ITEM 863920

GLS

Personal Care Solutions

Extra Strength

Menthol 16%

Pain Relief Sleeve

KNEE & Large Ankles & Elbows

Medicated Sleeve

Pain relieving Lotion on a Breathable Sleeve

Large Sleeve

Ideal for KNEE

EXPANDS TO FIT 8" TO 24" (20 CM TO 61 CM)

IN CIRCUMFERENCE

Contains 1 Sleeve Patch

KNEE

  • ELBOW
  • ANKLE
  • WRIST

NDC 64092-520-1, ITEM 863920

GLS

Personal Care Solutions

Extra Strength

Menthol 16%

Pain Relief Sleeve

KNEE & Large Ankles & Elbows

Medicated Sleeve

Pain relieving Lotion on a Breathable Sleeve

XLarge Sleeve

Ideal for KNEE

EXPANDS TO FIT 12" TO 28" (30.5 CM to 70 CM)

IN CIRCUMFERENCE

Contains 1 Sleeve Patch

KNEE

ELBOW
ANKLE
WRIST

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years: pull sleeve onto knee or large ankle or elbow until the colored section of the sleeve is positioned directly over the affected area. sleeve should feel snug, but not tight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Med Pain PatchMed Pain PatchLarge pain patchLarge pain patchX large pain patchX large pain patch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043743menthol 16 % Medicated PatchPSN1
1043743menthol 0.16 MG/MG Medicated PatchSCD1
1043743menthol 16 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64092-506-012020-01-31C16284748780-19d75b9d0-448c-f424-e053-dadaa90a57ce42f0f24c-97e0-4a3d-e054-00144ff8d46c
64092-520-012020-01-31C16284748780-19d75b9d0-448c-f424-e053-dadaa90a57ce42f0f24c-97e0-4a3d-e054-00144ff8d46c
64092-544-012020-01-31C16284748780-19d75b9d0-448c-f424-e053-dadaa90a57ce42f0f24c-97e0-4a3d-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64092-506-01Pain Relief SleeveMedium5 mL in 1 PATCHPATCH51
64092-520-01Pain Relief SleeveLarge5 mL in 1 PATCHPATCH51
64092-544-01Pain Relief SleeveExtra Large5 mL in 1 PATCHPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64092-506PAIN RELIEF SLEEVE LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE EXTRA LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE MEDIUM (MENTHOL) PATCH [GREAT LAKES WHOLESALE, MARKETING, AND SALES, INC]1Legacy NDC, 1 package rows20161207_42f0f24c-97e0-4a3d-e054-00144ff8d46c.zip
64092-520PAIN RELIEF SLEEVE LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE EXTRA LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE MEDIUM (MENTHOL) PATCH [GREAT LAKES WHOLESALE, MARKETING, AND SALES, INC]1Legacy NDC, 1 package rows20161207_42f0f24c-97e0-4a3d-e054-00144ff8d46c.zip
64092-544PAIN RELIEF SLEEVE LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE EXTRA LARGE (MENTHOL) PATCH PAIN RELIEF SLEEVE MEDIUM (MENTHOL) PATCH [GREAT LAKES WHOLESALE, MARKETING, AND SALES, INC]1Legacy NDC, 1 package rows20161207_42f0f24c-97e0-4a3d-e054-00144ff8d46c.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
64092-50664092-506-01
64092-52064092-520-01
64092-54464092-544-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
POLYSORBATE 806OZP39ZG8HIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CETYL ALCOHOL936JST6JCNIACT
MONOETHANOLAMINE5KV86114PTIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL ORANGE6B4TC34456IACT
EDETIC ACID9G34HU7RV0IACT
SOLASULFONEH12JE4313SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
POLYSORBATE 806OZP39ZG8HIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CETYL ALCOHOL936JST6JCNIACT
MONOETHANOLAMINE5KV86114PTIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL ORANGE6B4TC34456IACT
EDETIC ACID9G34HU7RV0IACT
SOLASULFONEH12JE4313SIACT
MENTHOLL7T10EIP3AACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
POLYSORBATE 806OZP39ZG8HIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CETYL ALCOHOL936JST6JCNIACT
MONOETHANOLAMINE5KV86114PTIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL ORANGE6B4TC34456IACT
EDETIC ACID9G34HU7RV0IACT
SOLASULFONEH12JE4313SIACT
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
42f0f24c-97e1-4a3d-e054-00144ff8d46c42f0f24c-97e0-4a3d-e054-00144ff8d46c2016-12-05WarningsExact identifier
spl id: 42f0f24c-97e1-4a3d-e054-00144ff8d46c
spl set id: 42f0f24c-97e0-4a3d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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