Cold and Hot Medicated Large Patch

Manufacturer
Universal Distribution Center LLC | Koolcare Technology Co., Ltd.
Effective date
2024-06-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:00:48

Label at a glance#

ProductCold and Hot Medicated Large
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

Temporarily relieve minor aches and pains of muscles and joints due to • simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps

Dosage and administration

Adults and Children 12 years of age and older: Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch Should be used up to 8 hours Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.

Storage and handling

store at room temperature 68° to 77°F (20° to 25°C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieve minor aches and pains of muscles and joints due to
• simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps

WARNINGS:

WARNINGS SECTION

EXTERNAL USE ONLY

When using this product
• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

STOP USE and ask a doctor if
• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 years of age and older:

  • Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
  • Should be used up to 8 hours
  • Should be used no more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

  • store at room temperature 68° to 77°F (20° to 25°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Icy Hot® Patch

EXTRA STRENGTH

Contains Menthol 5%

Pain relieving ointment on a breathable adhesive pad

EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove.

FAST RELIEF OF MINOR ACHES AND PAINS

*This product is NOT manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

Made in P.R.C.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHPatch-rev5CHPatch-rev5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-033COLD AND HOT MEDICATED LARGE (MENTHOL) PATCH [UNIVERSAL DISTRIBUTION CENTER LLC]5Legacy NDC20240614_dbc582bd-636f-469e-8aac-ecf5738e93c8.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
52000-03352000-033-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

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
f3ed1a1b-0c12-4bd8-b2e8-a3a4864de1a7dbc582bd-636f-469e-8aac-ecf5738e93c82025-07-21WarningsExact identifier
spl set id: dbc582bd-636f-469e-8aac-ecf5738e93c8

Reported adverse events (FAERS/openFDA)#

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