Cold-Hot Medicated Patches

Manufacturer
Shopko Stores Operating Co., LLC | Beijing HKKY Medical
Effective date
2017-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:33

Label at a glance#

ProductCold-Hot Medicated Patches
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Glycerin, Sodium Polyacrylate, Water, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium
Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
■ muscle strains ■ muscle sprains ■ bruises ■ cramps

WARNINGS

WARNINGS SECTION

For External Use Only.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, but no more than 4 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

When using this product

OTC - WHEN USING SECTION

Use only as directed ■ Don’t bandage tightly or use with heating pad
■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

Stop use and ask a doctor

OTC - STOP USE SECTION

If condition worsens ■ If redness is present ■ If irritation develops
■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for:
Veridian Healthcare
Gurnee, IL 60031 USA

Large Patch Label Image
Large Patch Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN1
420222menthol 0.05 MG/MG Medicated PatchSCD1
420222menthol 5 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37012-952-052020-01-31C16284748780-19d75b9d0-0ad8-f424-e053-dadaa90a57ceShopko Cold-Hot Medicated Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-952-05Cold-Hot Medicated Patches1 in 1 POUCHPATCH11
37012-952-05Cold-Hot Medicated Patches6 in 1 BOXPATCH61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-952COLD-HOT MEDICATED PATCHES (MENTHOL) PATCH [SHOPKO STORES OPERATING CO., LLC]1Legacy NDC, 2 package rows20180808_ea4d32f1-60b1-469d-917d-7eff4638dc08.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
37012-95237012-952-05

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
202bbd20-f767-4d06-ad1c-40863c6a887bea4d32f1-60b1-469d-917d-7eff4638dc082017-10-01WarningsExact identifier
spl id: 202bbd20-f767-4d06-ad1c-40863c6a887b
spl set id: ea4d32f1-60b1-469d-917d-7eff4638dc08

Reported adverse events (FAERS/openFDA)#

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