CORALITE COLD AND HOT MEDICATED- menthol patch 
United Exchange Corporation

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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90153 Coralite Cold & Hot Patch 2ct (NBE Icy Hot) (90153)

Active ingredient Purpose

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

Uses

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, soribitan monooleate, tartaric acid, titanium dioxide

Questions or comments?

Call 1-800-814-8028 Monday-Friday 9AM-5PM (PST)

Distributed By:

UNITED EXCHANGE CORP.

5836 Corporate Ave.

Cypress, CA. 90630 USA

1-800-814-8028

Made in China

90153

CORALITE COLD AND HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-147
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALCOHOL (UNII: 3K9958V90M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TARTARIC ACID (UNII: W4888I119H)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-147-021 in 1 POUCH10/23/2018
11 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/23/2018
Labeler - United Exchange Corporation (840130579)

Revised: 1/2022
Document Id: d5cce261-81d7-650a-e053-2a95a90a783d
Set id: 78ed2c27-9036-fe7f-e053-2991aa0a1ba2
Version: 3
Effective Time: 20220117
 
United Exchange Corporation