COLD AND HOT MEDICATED PATCH- menthol 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 Universal Distribution Center LLC, Zhejiang Dingtai Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

arthritis simple backache muscle strains bursitis tendonitis strains bruises cramps

WARNINGS

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 times a day  
• children under 12 years of age: consult a doctor

Other information

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

Inactive ingredients

glycerin, sodium polyacrylate, aluminum glycinate, kaolin, methylparaben, propylparaben, alcohol, titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80, purified 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

Packaging

INGREDIENTS AND APPEARANCE

COLD AND HOT MEDICATED PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	205.5 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-032-42	1 in 1 BOX	06/21/2017
1		2 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 not final	part348	06/21/2017

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(52000-032)