Cold Hot Medicated Patch 5% Menthol

Manufacturer
InterMed Laboratories Private Limited
Effective date
2025-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:25

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

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, isopropyl myristate, kaolin, methyl paraben, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxymethyl cellulose, sodium polyacrylate, sorbitan monooleate 80, sorbitol, tartaric acid, titanium dioxide, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PatPat

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71811-005-05Cold Hot Medicated Patch 5% Menthol1 in 1 POUCHPATCH12
71811-005-05Cold Hot Medicated Patch 5% Menthol5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71811-005COLD HOT MEDICATED PATCH 5% MENTHOL (MENTHOL) PATCH [INTERMED LABORATORIES PRIVATE LIMITED]2Current NDC, 2 package rows20250507_33ee0235-5a6e-0ea1-e063-6394a90a89a5.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
71811-00571811-005-05

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% MentholMENTHOLInterMed Laboratories Private Limited33ee0235-5a6e-0ea1-e063-6394a90a89a52025-05-06WarningsExact identifier
ndc (package): 71811-005-05
ndc (product): 71811-005
ndc11 (package): 71811000505
spl id: 34779952-9daf-c107-e063-6294a90a5c8b
spl set id: 33ee0235-5a6e-0ea1-e063-6394a90a89a5

Reported adverse events (FAERS/openFDA)#

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