COLD AND HOT MEDICATED LARGE- menthol patch 
Universal Distribution Center LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cold and Hot Medicated Large Patch

Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Uses

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 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 (1-800-222-1222) immediately.

DIRECTIONS

Adults and Children 12 years of age and older:

Children under 12 years of age: Consult a doctor.

Other information

Inactive ingredients

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

FAST RELIEF OF MINOR ACHES AND PAINS

*Compare to the active ingredient in Icy Hot® Patch

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.

*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

Largpth-1

COLD AND HOT MEDICATED LARGE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM428.5 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-033-411 in 1 BOX06/21/2017
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/21/2017
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(52000-033)

Revised: 3/2020
Document Id: cecb11b7-4f0c-4930-bcc7-8b0ec6027e39
Set id: dbc582bd-636f-469e-8aac-ecf5738e93c8
Version: 4
Effective Time: 20200313
 
Universal Distribution Center LLC