Cold Hot Medicated Patch 5% Menthol

Manufacturer
Veridian Healthcare | InterMed Laboratories Private Limited
Effective date
2025-03-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:58

Label at a glance#

ProductCold Hot Medicated Patch 5% Menthol
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient ...............................................................................................Purpose

Menthol 5%...............................................................................................Topical Analgesic

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

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.

When using this product

OTC - WHEN USING SECTION

When using this product

■ Use only as directed

■ Rare cases of serious burns have been reported with products of this type

■Don't bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes

■ Don't apply to wounds or damaged skin

■ Do not use at the same time as other topical analgesics.

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.■ You experience signs injury, such a s pain, swelling, or blistering where the product was applied.

If pregnant or breastfeeding

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

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

Children under 12 years of age: consult a physician.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

dihydroxyaluminium aminoacetate, disodium EDTA, gelatin, glycerin, isopropyl myristate, methyl paraben, polysorbate 80, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, sorbitan monoleate 80, sorbitol, tartaric ac d, titanium dioxide, urea, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN2
420222menthol 0.05 MG/MG Medicated PatchSCD2
420222menthol 5 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-060-05Cold Hot Medicated Patch 5% Menthol1 in 1 POUCHPATCH12
71101-060-05Cold Hot Medicated Patch 5% Menthol5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-060COLD HOT MEDICATED PATCH 5% MENTHOL (MENTHOL) PATCH [VERIDIAN HEALTHCARE]2Current NDC, 2 package rows20250313_2d413707-794c-2fa8-e063-6394a90a06bf.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-06071101-060-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d413707-794c-2fa8-e063-6394a90a06bf2025-03-11WarningsExact identifier
ndc (package): 71101-060-05
ndc (product): 71101-060
ndc11 (package): 71101006005
spl id: 30119772-fbfe-1feb-e063-6394a90a3d3a
spl set id: 2d413707-794c-2fa8-e063-6394a90a06bf

Reported adverse events (FAERS/openFDA)#

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