FDA.reportPublic FDA data

COLD AND HOT MEDICATED PATCH

Manufacturer
Universal Distribution Center LLC
Effective date
2025-09-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:38:51

Label at a glance#

ProductCOLD AND HOT MEDICATED
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

Temporarily relieve minor pain associated with: • arthritis • simple backache • muscle strains • bursitis • tendonitis • strains • 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 pain associated with:
• arthritis • simple backache • muscle strains • bursitis • tendonitis • strains • bruises • cramps

WARNINGS

WARNINGS SECTION

For 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
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

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Icy Hot® Patch

EXTRA STRENGTH

Contains Menthol 5%

Works on contact for cooling pain relief

Pain relieving ointment on a breathable adhesive pad

*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 CHINA

www.universaldc.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLD AND HOT MEDICATEDCOLD AND HOT MEDICATED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN7
420222menthol 0.05 MG/MG Medicated PatchSCD7
420222menthol 5 % Medicated PatchSY7

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
52000-422-41COLD AND HOT MEDICATED2 in 1 POUCHPATCH27
52000-422-41COLD AND HOT MEDICATED8.5 g in 1 PATCHPATCH8.57
52000-422-42COLD AND HOT MEDICATED24 in 1 BOXPATCH247
52000-422-42COLD AND HOT MEDICATED2 in 1 POUCHPATCH27

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-42252000-422-41, 52000-422-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-07-29full-release2026-06-01 01:08:53

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 AND HOT MEDICATEDMENTHOLUniversal Distribution Center LLCc19aa620-401d-43c4-804c-3611cc39e9f22025-09-29WarningsExact identifier
ndc (package): 52000-422-41
ndc (package): 52000-422-42
ndc (product): 52000-422
ndc11 (package): 52000042241
ndc11 (package): 52000042242
spl id: 9e02f5b6-ecf5-4f1e-8b28-196b86d0f325
spl set id: c19aa620-401d-43c4-804c-3611cc39e9f2

Reported adverse events (FAERS/openFDA)#

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