CORALITE COLD AND HOT- menthol patch

Coralite Cold and Hot by

Drug Labeling and Warnings

Coralite Cold and Hot by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

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

PURPOSE

Uses

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

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad or at the same time with other topical analgesic
• on a child under 12 years of age with arthritis-like conditions

ASK DOCTOR

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

WHEN USING

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

STOP USE

Stop use and ask a doctor if

• conditions worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• open pouch and remove patch
• carefully peel off protective backing and apply sticky side to affected area
• adults and children 12 years of age and older:
• do not wear patch for more than 8 hours
• apply to affected area no more than 3 times daily
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by:

UNITED EXCHANGE CORP.

Cypress, CA 90630 USA

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE COLD AND HOT 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	210 mg

Inactive Ingredients
Ingredient Name	Strength
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)
LANOLIN (UNII: 7EV65EAW6H)
GLYCERYL ROSINATE (UNII: SD112V492J)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-214-01	1 in 1 POUCH; Type 0: Not a Combination Product	09/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/26/2023

Labeler - United Exchange Corp. (840130579)