CORALITE COLD AND HOT MEDICATED- menthol patch

Coralite Cold and Hot Medicated by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Menthol 5%..................................Topical Analgesic

PURPOSE

Uses

• temporarily relives minor aches and pains of muscles and joints associated with:
• simple backache
• arthritis
• strains
• brusies
• sprains

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad
• 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

Stope use and ask a doctor if

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

QUESTIONS

Questions or comments?

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

DOSAGE & ADMINISTRATION

Distributed By:

UNITED EXCHANGE CORP.

Cypress, CA. 90630 USA

1-800-814-8028

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORALITE COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-154-01	1 in 1 POUCH	10/22/2018
1		5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/22/2018

Labeler - United Exchange Corporation (840130579)