Thera Care Cold Hot Medicated Patch

Manufacturer
Veridian Healthcare | Unexo Life Sciences, Private Limited
Effective date
2024-08-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:18:13

Label at a glance#

ProductThera Care Cold Hot Medicated Patch
Active ingredientMENTHOL
Label structure12 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 aches and pains of muscles and joints: ■ 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

Use only as directed

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

■ Don’t bandage tightly or use with a 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 ■ redness is present ■ If irritation develops ■symptoms persist for more than 7 days or clear up and occur again within a few days.■ You experience signs of skin injury, such as 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 in infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away

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 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age: Consult a physician.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature, not to exceed 86F (30C)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients

alcohol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methacrylic ac d and ethyl acrylate copolymer, methylparaben, polysorbate 80, polyvinyl alcohol, povidone, propylparaben, sodium polyacrylate, sorb tan monooleate, sorb tol, tartaric acid, titanium dioxide, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackPack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN3
420222menthol 0.05 MG/MG Medicated PatchSCD3
420222menthol 5 % Medicated PatchSY3

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
71101-954-05Thera Care Cold Hot Medicated Patch5 in 1 BOXPATCH53
71101-954-05Thera Care Cold Hot Medicated Patch9 g in 1 POUCHPATCH93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-954THERA CARE COLD HOT MEDICATED PATCH (MENTHOL) PATCH [VERIDIAN HEALTHCARE]3Current NDC, Legacy NDC, 2 package rows20240830_b1ce129d-06a1-7755-e053-2995a90abd7d.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
71101-95471101-954-05

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
Thera Care Cold Hot Medicated PatchMENTHOLVeridian Healthcareb1ce129d-06a1-7755-e053-2995a90abd7d2024-08-29WarningsExact identifier
ndc (package): 71101-954-05
ndc (product): 71101-954
ndc11 (package): 71101095405
spl id: 20d6f5cc-2c81-74a0-e063-6394a90abfed
spl set id: b1ce129d-06a1-7755-e053-2995a90abd7d

Reported adverse events (FAERS/openFDA)#

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