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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Active ingredient Purpose

Menthol 7.5%...............................................................Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

Warnings

For external use only

Do not use

Ask a doctor before use if you have redness over the affected area

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

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

Inactive ingredients

aluminum silicate, butylated hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, polyisobutylene (85000 MW), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

Distributed by:

UNITED EXCHANGE CORP.

Cypress, CA 90630 USA

Made in China

90214.1

CORALITE COLD AND HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-214
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL210 mg
Inactive Ingredients
Ingredient NameStrength
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
LANOLIN (UNII: 7EV65EAW6H)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)  
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
GLYCERYL ROSINATE (UNII: SD112V492J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-214-011 in 1 POUCH; Type 0: Not a Combination Product09/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/26/2023
Labeler - United Exchange Corp. (840130579)

Revised: 9/2023
Document Id: 064a6149-a0e3-8a73-e063-6394a90a7953
Set id: 064a6149-a0e2-8a73-e063-6394a90a7953
Version: 1
Effective Time: 20230926
 
United Exchange Corp.