CORALITE COLD AND HOT- menthol patch 
United Exchange Corp.

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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Coralite Pain Relief menthol Patch 2 ct. 90150 (2021) ZDP

Drug Facts

Active ingredient Purpose

Menthol 5%......................................................Topical analgesic

Uses

Warnings

For external use only

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

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) right away.

Directions

Other information

Inactive ingredients

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

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in China

90150.1

CORALITE COLD AND HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
TARTARIC ACID (UNII: W4888I119H)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
KAOLIN (UNII: 24H4NWX5CO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-205-022 in 1 POUCH04/04/2019
11 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/04/2019
Labeler - United Exchange Corp. (840130579)

Revised: 5/2023
Document Id: fb344343-9c5f-9e81-e053-6394a90ada74
Set id: 85bd7658-e951-7daf-e053-2a91aa0a9f54
Version: 4
Effective Time: 20230508
 
United Exchange Corp.