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

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

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

CHPatch-rev5

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)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
KAOLIN (UNII: 24H4NWX5CO)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL 95% (UNII: 7528N5H79B)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
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 DrugM01706/21/2017
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
Koolcare Technology Co., Ltd.602479389manufacture(52000-033)

Revised: 6/2024
Document Id: 0cf74d17-574c-40b0-8a3e-0953838b9a22
Set id: dbc582bd-636f-469e-8aac-ecf5738e93c8
Version: 5
Effective Time: 20240604
 
Universal Distribution Center LLC