COLD AND HOT MEDICATED PATCH patch

COLD AND HOT MEDICATED Patch by

Drug Labeling and Warnings

COLD AND HOT MEDICATED Patch by is a Otc medication manufactured, distributed, or labeled by Henan Enokon Medical Instrument Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Use

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

Warnings

EXTERNAL USE ONLY

When Using

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

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

Ask Doctor

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

Keep Out Of Reach Of Children

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

Directions

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

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

*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 CHINA

www.universaldc.com

Inactive ingredients

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

Questions

www.universaldc.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD AND HOT MEDICATED PATCH 
cold and hot medicated patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83559-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83559-015-01	24 in 1 BOX	01/31/2026
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/31/2026

Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Enokon Medical Instrument Co., Ltd.		701730676	manufacture(83559-015)